NCT Number Title Acronym Status Conditions Interventions Outcome Measures Sponsors Gender Age Enrollment Funders Study Type Study Designs Other IDs Start Date Primary Completion Date Completion Date Last Verified First Submitted First Posted Results First Submitted Results First Posted Last Update Submitted Last Update Posted URL Setting Stage Sponsor_Type Controlled Multi-Arm Pediatric Country_PI Cancer_Group Cancer_Type Drug_INN Primary-EP Phase DrugBank Removed
NCT03170115 Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer ICAR Recruiting Rectal Cancer, Adenocarcinoma|Locally Advanced Malignant Neoplasm|Chemoradiation Drug: Aspirin; Drug: Placebo Oral Tablet Tumor downstaging after induction chemotherapy followed by chemoradiotherapy with or without aspirin; Radiological Tumor response rate after induction chemotherapy; Pathological Tumor response rate; Pathologic complete response; Disease-free survival; Overall survival Instituto Nacional de Cancer, Brazil All 18 Years to 75 Years (Adult, Older Adult) 80 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment ICAR trial 30/11/2017 07/01/2022 07/01/2022 30/05/2017 28/02/2018 https://ClinicalTrials.gov/show/NCT03170115 Advanced/Metastatic Hospital/University/Research Institute Y N N Brazil GI Rectal Cancer Acetylsalicylic Acid Response rate; OS; DFS/RFS/EFS; Other (specify) Phase 2 DB01048 N
NCT02969681 Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer Vitality Recruiting Colorectal Neoplasms Drug: ascorbic acid; Drug: Chemotherapy Progression Free Survival; Overall Survival; Response Rate Sun Yat-sen University All 18 Years to 75 Years (Adult, Older Adult) 428 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VitC001 01/01/2017 12/01/2019 12/01/2020 21/11/2016 27/02/2019 https://ClinicalTrials.gov/show/NCT02969681 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Colon Cancer Ascorbic acid PFS Phase 3 DB00335 N
NCT02678975 Disulfiram in Recurrent Glioblastoma Active, not recruiting Glioma|Glioblastoma Drug: Disulfiram; Dietary Supplement: Copper; Drug: Alkylating Agents Survival 6 mo; Progression free survival; Survival 12 and 24 mo; Median overall survival; Health related quality of life; Volumetric tumor assessment; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Sahlgrenska University Hospital, Sweden; St. Olavs Hospital; Lund University Hospital; Karolinska University Hospital; University Hospital, Linkoeping; Region rebro County; Ryhov County Hospital; Uppsala University Hospital All 18 Years and older (Adult, Older Adult) 88 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment no ID yet 01/01/2017 15/01/2021 15/01/2021 02/10/2016 11/09/2020 https://ClinicalTrials.gov/show/NCT02678975 Recurrent/Refractory Hospital/University/Research Institute Y N N Sweden CNS Glioblastoma Disulfiram OS Phase 2/3 DB00843 N
NCT01844076 Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal ADenocarcinoma Active, not recruiting Colorectal Adenocarcinoma Drug: Phase I (Quinacrine); Drug: Capecitabine Phase I - Tolerability and Safety; Phase II - Rate of Response Fox Chase Cancer Center All 18 Years and older (Adult, Older Adult) 19 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GI-078 01/01/2016 04/01/2021 04/01/2021 05/01/2013 05/07/2020 https://ClinicalTrials.gov/show/NCT01844076 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Mepacrine Safety and/or Dose; Response rate Phase 1/2 DB06691 N
NCT01342692 Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes AZA-PLUS Active, not recruiting MDS Drug: Azacitidine; Drug: Azacitidine associated with Valproic acid; Drug: Azacitidine associated with Lenalidomide; Drug: Azacitidine associated with Idarubicine Remission, complete, partial or medullary after 6 cycles; Stable disease with hematological improvement; Duration of response; Progression to acute myeloid leukemia; Overall survival; Number of adverse events Assistance Publique - H pitaux de Paris All 18 Years and older (Adult, Older Adult) 320 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment P081225 06/01/2011 07/01/2018 06/01/2019 27/04/2011 19/02/2019 https://ClinicalTrials.gov/show/NCT01342692 Localised/Locoregional Hospital/University/Research Institute Y Y N France Other Haem-onc Myelodysplastic Syndromes Valproic Acid Safety and/or Dose; Response rate; OS; Other (specify) Phase 2 DB00177 N
NCT04054362 Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma PINBALL Recruiting Pancreatic Cancer Drug: Paclitaxel protein bound; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paricalcitol Clinical benefit Barts The London NHS Trust All 18 Years and older (Adult, Older Adult) 14 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 12255 29/11/2018 30/06/2021 30/06/2021 13/08/2019 16/12/2019 https://ClinicalTrials.gov/show/NCT04054362 Advanced/Metastatic Hospital/University/Research Institute N N N United Kingdom GI Pancreatic Cancer Paricalcitol Other (specify) Phase 2 DB00715 N
NCT01586260 Preventative Trial of DFMO in Patients With High Risk Neuroblastoma in Remission Active, not recruiting Neuroblastoma Drug: DFMO To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS); To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS); Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Biology studies Giselle SaulnierSholler; Cancer Prevention Pharmaceuticals, Inc.; University of Arizona; University of Hawaii; University of Vermont; Beat NB Cancer Foundation; Atrium Health All up to 21 Years (Child, Adult) 89 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention NMTRC 003 06/01/2012 26/04/2021 26/04/2021 26/04/2012 18/11/2020 https://ClinicalTrials.gov/show/NCT01586260 Localised/Locoregional Hospital/University/Research Institute N N Y United States Other Neuroblastoma Eflornithine DFS/RFS/EFS Phase 2 DB06210 N
NCT04096911 Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer Recruiting Uterine Cervical Neoplasms|Cervical Cancer|Cervical Neoplasms|Cervix Cancer Drug: Sintilimab; Drug: quadrivalent HPV vaccine Objective Response Rate; Progression-free survival; Overall survival; Duration of Response Buhai Wang; Innovent Biologics (Suzhou) Co. Ltd.; Northern Jiangsu Province People's Hospital Female 18 Years and older (Adult, Older Adult) 20 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment WBH-7209 31/07/2019 31/03/2021 31/03/2021 20/09/2019 20/09/2019 https://ClinicalTrials.gov/show/NCT04096911 Recurrent/Refractory Company N N N China Gynaecological Cervical Cancer HPV vaccine Response rate; PFS; OS; Other (specify) Phase 2 DB01275 N
NCT03831178 Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting DHA-WIN Recruiting Breast Cancer Dietary Supplement: Docosahexaenoic acid (DHA); Drug: Placebo oral capsule Percent change in Ki67 index from baseline to surgical excision.; Percent of DHA in plasma phospholipids between DHA and placebo arms.; Change in immune function (e.g. ability to produce IL-2 after stimulation) following DHA supplementation in combination with chemotherapy.; Age of participants and other factors affecting DHA incorporation; Percent change on markers of apoptosis (e.g. caspase-3) following DHA or placebo supplementation.; Pathological complete response rate; Comparison of rate of chemotherapy associated grade 3 and 4 toxicities between treatment arms. AHS Cancer Control Alberta; Canadian Institutes of Health Research (CIHR); University of Alberta Female 18 Years and older (Adult, Older Adult) 52 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment IIT-0005 28/08/2019 03/01/2021 09/01/2021 02/05/2019 10/02/2019 https://ClinicalTrials.gov/show/NCT03831178 Localised/Locoregional Collaborative Group Y N N Canada Breast Any Breast Cancer Omega 3 Biomarker Phase 2 DB00338 N
2020-000725-27 Intratumoral Influenza Vaccine for Early Colorectal Cancer Ongoing Patients with colorectal cancer Drug: Influenza vaccine Safety endpoints Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. We will conduct the pilot study in order to measure potential safety issues in a small cohort of patients before including patients in the phase 2 study. The investigation will be put on hold if unacceptable safety issues are detected. Primary safety endpoints: 1. Evaluation of serious adverse events 2. Evaluation of any adverse events reported. Center for Surgical Science, Department of Surgery, Zealand University Hospital All Adult 18-64 30 Not applied yet - https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000725-27/DK Localised/Locoregional Hospital/University/Research Institute N N N Denmark GI Colon Cancer; Rectal Cancer Influenza vaccine Safety and/or Dose Phase 2 DB01029 N
NCT02607072 Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients: a Multi-center Randomized Trial APREMEC Recruiting Colorectal Cancer Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily; Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily; Drug: Placebo 3-year disease free survival The Fourth Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University; Anhui Provincial Hospital All 18 Years and older (Adult, Older Adult) 3000 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment APREMEC-01 10/01/2015 10/01/2020 10/01/2022 17/11/2015 18/11/2015 https://ClinicalTrials.gov/show/NCT02607072 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y Y N China GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 3 DB01048 N
NCT03491410 Breast Cancer Active Surveillance, Alternative Option, Aspirin Included Not yet recruiting Breast Cancer Drug: Aspirin Low Dose; Drug: Placebo Oral Tablet Overall Survival; Metastatic Disease Stability; Tumor response till patient decides to exit the active surveillance Centro Hospitalar Lisboa Ocidental All 18 Years and older (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment CHLOBREASTASP 06/01/2018 31/12/2019 31/05/2023 04/09/2018 04/09/2018 https://ClinicalTrials.gov/show/NCT03491410 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Portugal Breast Breast - Other Acetylsalicylic Acid Response rate; OS Phase 2/3 DB01048 N
NCT02945033 Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk ASPIK French Recruiting Colorectal Cancer Drug: aspirin intake; Drug: placebo intake; Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk; Biological: Molecular analysis of exon 9 and 20 of PI3K; Biological: blood intake Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first; Number of alive patient; Number of pills taken by the patient for compliance evaluation; Number of severe bleeding grade 3-4 events; Number of participants with treatment-related adverse events University Hospital, Rouen; Federation Francophone de Cancerologie Digestive All 18 Years and older (Adult, Older Adult) 264 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2015/222/HP 07/12/2018 07/01/2024 07/01/2024 26/10/2016 24/10/2019 https://ClinicalTrials.gov/show/NCT02945033 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N France GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Safety and/or Dose; OS; Recurrence rate Phase 3 DB01048 N
NCT03464305 ASPIRIN Trial Belgium ASPIRIN Recruiting Colon Cancer Drug: acetylsalicylic acid; Drug: Placebo 5 year overall survival; Disease Free Survival; Time to Treatment Failure University Hospital, Antwerp; Kom Op Tegen Kanker; Anticancerfund All 45 Years and older (Adult, Older Adult) 400 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment BE 2017-001397-41 22/02/2018 31/12/2026 31/12/2026 14/03/2018 22/12/2020 https://ClinicalTrials.gov/show/NCT03464305 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Belgium GI Colon Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 3 DB01048 N
NCT01936233 Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery Recruiting Hepatocellular Carcinoma|Recurrence Drug: Aspirin; Drug: Lamivudine recurrence free survival; overall survival; adverse events Fudan University All 18 Years to 75 Years (Adult, Older Adult) 112 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LC-ASPIRIN 08/01/2013 12/01/2021 12/01/2023 09/06/2013 08/05/2019 https://ClinicalTrials.gov/show/NCT01936233 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 3 DB01048 N
NCT02804815 Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours Recruiting Cancer|Breast Cancer|Prostate Cancer|Colorectal Cancer|Gastro-oesophageal Cancer Drug: Aspirin 100mg; Drug: Aspirin 300mg; Drug: Placebo 100mg; Drug: Placebo 300mg Overall Survival; Invasive disease-free survival (IDFS); Disease-free survival (DFS); Overall survival; Biochemical recurrence-free survival (bRFS); Adherence; Number of participants with serious haemorrhage (grade 3 or above) as measured by CTCAE V4.0. Data will be collected on case report forms.; Number of participants with treatment-related (active drug and placebo) cardiovascular events as assessed by CTCAE v4.0; Number of participants with second malignancies as assessed by case report form; Number of participants that show a decline in cognition and extent of decline as assessed by the Montreal Cognitive Assessment (MoCA) University College, London All 16 Years and older (Child, Adult, Older Adult) 11000 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Other 14/0814; 2013-004398-28; 120104 10/01/2015 10/01/2026 10/01/2026 17/06/2016 21/02/2021 https://ClinicalTrials.gov/show/NCT02804815 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y Y N United Kingdom Breast; Urological; GI Any Breast Cancer; Prostate Cancer; Esophageal Cancer; Colon Cancer; Rectal Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS; Recurrence rate Phase 3 DB01048 N
NCT03900871 Clinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma Not yet recruiting Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma Drug: Acetylsalicylic acid disease free survival Hebei Medical University Fourth Hospital All 18 Years to 70 Years (Adult, Older Adult) 600 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2018051702 04/10/2019 30/04/2020 30/04/2024 04/03/2019 04/03/2019 https://ClinicalTrials.gov/show/NCT03900871 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Esophageal Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 1 DB01048 N
NCT03290820 Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients Not yet recruiting Nasopharyngeal Carcinoma Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Aspirin Distant-metastasis-free survival; Overall survival; Aspirin-related toxicities Sun Yat-sen University All 18 Years to 70 Years (Adult, Older Adult) 184 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2017-FXY-067 01/01/2018 30/09/2024 30/09/2024 25/09/2017 26/10/2017 https://ClinicalTrials.gov/show/NCT03290820 Localised/Locoregional Hospital/University/Research Institute Y N N China Head and Neck Nasopharyngeal Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 2 DB01048 N
NCT04840004 Efficacy and Safety of High Dose Aprepitant Treatment in Patients With Advanced Non-Small Cell Lung Cancer Recruiting Non Small Cell Lung Cancer|Advanced Cancer|Refractory Cancer Drug: Aprepitant Effect; Progression Free Survival and Overall Survival; High Dose PlusVitech S.L.; ECONiX Ara t rma Analiz ve Dan manl k A. . All 18 Years and older (Adult, Older Adult) 24 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PLUSV_00 03/10/2021 15/12/2021 15/12/2021 04/09/2021 05/04/2021 https://ClinicalTrials.gov/show/NCT04840004 Advanced/Metastatic; Recurrent/Refractory Company N N N Turkey Lung Non-Small Cell Lung Cancer Aprepitant Response rate Phase 2 DB06692 N
NCT04801511 Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer CORT Recruiting Rectal Cancer Drug: Vitamin C PCR rate; acute toxicity; Resection rate of anus preserving surgery; 2-year survival rate; 2-year disease-free survival rate Zhou Fuxiang; Zhongnan Hospital All 18 Years to 70 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCCSC R02 03/08/2021 30/06/2023 31/12/2024 17/03/2021 17/03/2021 https://ClinicalTrials.gov/show/NCT04801511 Localised/Locoregional Hospital/University/Research Institute N N N China GI Rectal Cancer Ascorbic acid Response rate Phase 2 DB00335 N
NCT04463459 Effect of Vitamin C and E in Breast Cancer Patients Undergoing Chemotherapy Recruiting Breast Cancer Drug: Vitamin C, Vitamin E To measure the serum level of MDA and RBC glutathione in breast cancer patients receiving chemotherapy and following administration of vitamin C and vitamin E concurrent to chemotherapy. Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Female 30 Years to 70 Years (Adult, Older Adult) 80 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment BSMMU/2019/8874 10/10/2019 20/07/2020 15/09/2020 07/09/2020 07/09/2020 https://ClinicalTrials.gov/show/NCT04463459 Any/All Stages Hospital/University/Research Institute Y N N Bangladesh Breast Any Breast Cancer Ascorbic acid Biomarker Other DB00335 N
NCT04035096 The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients Not yet recruiting Colon Cancer Stage Iv Drug: Ascorbic Acid; Other: Control group Change from baseline by computerized tomography of Chest, abdomen and pelvis; Number of participants with changes of tumor markers National Taiwan University Hospital All 20 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201901083MINB 01/01/2020 31/12/2021 30/06/2022 29/07/2019 29/07/2019 https://ClinicalTrials.gov/show/NCT04035096 Advanced/Metastatic Hospital/University/Research Institute Y N N Taiwan GI Colon Cancer Ascorbic acid Response rate Phase 1/2 DB00335 N
NCT04516681 IV Ascorbic Acid in Peritoneal Metastatic Colorectal Cancer Recruiting Colorectal Cancer|Vitamin C|GLUT3 Drug: Ascorbic acid; Drug: FOLFOXIRI Protocol Objective Response Rate; Progression Free Survival; Overall Survival Fudan University All 18 Years to 75 Years (Adult, Older Adult) 400 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Vitamin C-GLUT3-2020 09/01/2020 09/01/2022 09/01/2023 18/08/2020 18/08/2020 https://ClinicalTrials.gov/show/NCT04516681 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Colon Cancer Ascorbic acid Response rate Phase 3 DB00335 N
NCT04488783 Potentiation of Chemotherapy in Brain Tumors by Zinc Recruiting Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically Dietary Supplement: zinc and ascorbate progression free survival (PFS); overall survival (OS); Tcell count; Level of Interleukin 6; Tumor Necrosis Factor quantification Sheba Medical Center All 18 Years to 90 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 4266-17-SMC 30/07/2020 30/07/2022 30/12/2022 28/07/2020 28/07/2020 https://ClinicalTrials.gov/show/NCT04488783 Localised/Locoregional Hospital/University/Research Institute N N N Israel CNS Glioblastoma Ascorbic acid PFS Other DB00335 N
NCT03799094 Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations Recruiting Carcinoma, Non-Small-Cell Lung Drug: Vitamin C; Drug: Tyrosine kinase inhibitor Progression free survival; Overall survival Clifford Hospital, Guangzhou, China All 18 Years to 75 Years (Adult, Older Adult) 150 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 2/2018-19 12/05/2018 31/12/2020 31/12/2022 01/10/2019 01/10/2019 https://ClinicalTrials.gov/show/NCT03799094 Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Ascorbic acid PFS Phase 1/2 DB00335 N
NCT03986268 Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy Recruiting Vitamin D Deficiency|Chemotherapy Effect|Pathology Drug: Vit D pathological complete response (PCR); pathological complete response (PCR) relations with vitamin D levels; pathological complete response (PCR) ratio regarding molecular sub types Florence Nightingale Hospital, Istanbul Female 18 Years to 65 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019-40016-06 05/10/2019 12/10/2020 12/10/2020 14/06/2019 22/07/2020 https://ClinicalTrials.gov/show/NCT03986268 Localised/Locoregional Hospital/University/Research Institute Y N N Turkey Breast Any Breast Cancer Cholecalciferol Response rate Other Not found in DrugBank N
NCT03389659 XELOX/mFOLFOX Plus Vitamin D3 vs. XELOX/mFOLFOX as Firstline Chemotherapy in mCRC Not yet recruiting Vitamin D3 Drug: vitamin D3; Drug: Placebo PFS(progression-free survival); OS(overall survival); DCR; ORR; Incidence of Treatment-Emergent Adverse Events Tianjin Medical University Cancer Institute and Hospital All 18 Years and older (Adult, Older Adult) 750 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment TianjinCIH20171212 02/01/2018 12/01/2021 06/01/2022 01/03/2018 01/03/2018 https://ClinicalTrials.gov/show/NCT03389659 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Cholecalciferol PFS Phase 3 Not found in DrugBank N
NCT03652467 The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma Recruiting Hepatocellular Carcinoma Non-resectable Drug: Conventional TACE; Drug: Deferoxamine and conventional TACE Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer; Time to Progression; Overall Survival; Percentage of Participants With Complete Response or Partial Response; Duration of Response; Tumor Necrosis; Number of Participants With Iron Reduction of Liver; The Prognostic Value of Reduction of Liver Iron; Number of Participants With Drug-Related Treatment-Emergent Adverse Events Jinan Military General Hospital All 18 Years and older (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment JNZY20181245 09/01/2018 09/01/2022 31/12/2023 29/08/2018 22/02/2019 https://ClinicalTrials.gov/show/NCT03652467 Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Liver Cancer Deferoxamine PFS Phase 1 DB04932 N
NCT04265274 Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer. Recruiting Metastatic Breast Cancer Drug: Disulfiram; Drug: Vinorelbin; Drug: Cisplatin; Drug: Copper Objective response rates; Progression-free survival; overall survival National Cancer Institute, Slovakia Female 18 Years and older (Adult, Older Adult) 28 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BREAST-SK-001 01/01/2020 01/01/2022 01/01/2023 02/11/2020 03/03/2021 https://ClinicalTrials.gov/show/NCT04265274 Recurrent/Refractory Hospital/University/Research Institute N N N Slovakia Breast Breast Cancer - ER/HR+; Breast Cancer - HER2- Disulfiram Response rate Phase 2 DB00843 N
NCT03950830 Disulfiram and Cisplatin in Refractory TGCTs. DISGCT Recruiting Germ Cell Tumor Drug: Disulfiram Overall response rate; Progression-free survival; Overall survival National Cancer Institute, Slovakia Male 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GCT-SK-006 14/05/2019 31/12/2021 31/12/2022 15/05/2019 08/06/2020 https://ClinicalTrials.gov/show/NCT03950830 Recurrent/Refractory Hospital/University/Research Institute N N N Slovakia Urological Testicular Cancer Disulfiram Response rate Phase 2 DB00843 N
NCT04226066 Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors Recruiting Advanced Malignant Solid Tumors Biological: T601; Combination Product: T601+5-FC AEs (adverse events); Assessment of ORR (objective response rate); Assessment of DCR (disease control rate); Assessment of PFS (progression free survival); Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.; Determination of 5-FC, 5-FU and FBAL concentration in plasma by updated LC/MS/MS method; T601 antibody test by ELISA Tasly Tianjin Biopharmaceutical Co., Ltd. All 18 Years to 75 Years (Adult, Older Adult) 69 Industry Interventional Study Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment T60101 20/11/2019 31/05/2021 31/05/2022 13/01/2020 12/07/2020 https://ClinicalTrials.gov/show/NCT04226066 Advanced/Metastatic Company N N N China Multiple cancer types Any solid tumours Flucytosine Safety and/or Dose; Response rate Phase 1/2 DB04841 N
NCT03848039 Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9 HOPE9 Not yet recruiting Cervical Intraepithelial Neoplasia Biological: Gardasil-9; Drug: Placebo evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix); impact of the vaccine on prevalent post-surgery infections; impact of the vaccine in the post-surgical surveillance times, comparison of viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic picture in the post-operative period Alessandro Ghelardi; Azienda USL Toscana Nord Ovest Female 18 Years and older (Adult, Older Adult) 1220 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention HOPE9 STUDY; 2018-003507-19 12/01/2020 12/01/2022 05/01/2028 20/02/2019 11/05/2020 https://ClinicalTrials.gov/show/NCT03848039 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Italy Gynaecological Cervical Cancer HPV vaccine Recurrence rate Phase 3 DB01275 N
NCT02416739 Anticancer Activity of Nicotinamide on Lung Cancer Active, not recruiting Non-Small-Cell Lung Carcinoma Drug: Nicotinamide Hazard ratio (PFS) of the nicotinamide arm to the placebo arm; Response rate; Difference in quality of life between the nicotinamide arm and the placebo arm; Overall survival Il Yeong Park, Ph.D.; Chungbuk National University All 18 Years and older (Adult, Older Adult) 110 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment Amina-X-002 03/01/2015 03/01/2020 06/01/2020 15/04/2015 27/01/2020 https://ClinicalTrials.gov/show/NCT02416739 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Korea, Republic of Lung Non-Small Cell Lung Cancer Nicotinamide Response rate; PFS; OS; QoL Phase 2/3 DB01115 N
NCT03516253 Fish Oil and EPO in Breast Cancer Active, not recruiting Breast Cancer Dietary Supplement: Fish oil + EPO Change in disease status; Change in quality of life; Changes in nutritional status; Changes in lipid profiles; Changes in plasma fatty acids profiles; Changes in interleukins; Changes in activity of superoxide dismutase.; Changes in activity of catalase.; Changes in activity of glutathion peroxidase.; Changes in activity of glutathion reductase. University of Belgrade Female 45 Years to 65 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science VMA-253-18 20/02/2019 20/12/2022 20/06/2023 05/04/2018 05/04/2021 https://ClinicalTrials.gov/show/NCT03516253 Localised/Locoregional Hospital/University/Research Institute Y N N Serbia Breast Any Breast Cancer Omega 3 Safety and/or Dose; Response rate; QoL; Biomarker Other DB00338 N
NCT04664816 Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer Recruiting Non-Muscle Invasive Bladder Cancer Drug: n-3PUFAs Treatment; Drug: Placebo Treatment Time to first recurrence.; Recurrence-free survival Mansoura University All 18 Years to 90 Years (Adult, Older Adult) 110 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Prevention Omega3-NMIBC 12/01/2020 12/01/2022 12/01/2023 12/11/2020 21/12/2020 https://ClinicalTrials.gov/show/NCT04664816 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Urological Bladder Cancer Omega 3 DFS/RFS/EFS; Recurrence rate Other DB00338 N
NCT04175769 EPA+DHA for Non-small Cell Lung Cancer Patients. Not yet recruiting Non-small Cell Lung Cancer Dietary Supplement: Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); Other: Placebo Disease control rate; Progression-free survival; 1-year survival; Chemotherapy-induced toxicities; Change in skeletal muscle mass and adipose tissue; Change in Serum CRP; Change in Serum Albumin; Change in Fatty Acid Incorporation and Omega-3 Index; Changes in Quality of Life AHS Cancer Control Alberta; Cross Cancer Institute All 18 Years and older (Adult, Older Adult) 88 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment IIT-0001 01/01/2020 03/01/2022 09/01/2022 25/11/2019 26/11/2019 https://ClinicalTrials.gov/show/NCT04175769 Advanced/Metastatic Collaborative Group Y N N Canada Lung Non-Small Cell Lung Cancer Omega 3 Safety and/or Dose; PFS; OS; QoL; Biomarker Other DB00338 N
NCT03357757 Avelumab With Valproic Acid in Virus-associated Cancer LATENT Recruiting Cancer That is Associated With a Chronic Viral Infection|p16 Positive SCCHN|Squamous Cell Carcinoma of the Cervix|p16 Positive Squamous Cell Carcinoma of the Vagina or Vulva|p16 Positive Squamous Cell Carcinoma of the Penis|p16 Positive Squamous Cell Carcinoma of the Anus or Anal Canal|EBER Positive NPC|EBER Positive Hodgkins and Non-hodgkins Lymphona Drug: Valproic Acid; Biological: Avelumab Efficacy of Avelumab and VPA; Proportion of subjects who complete 4 doses of Avelumab in combination with VPA; Overall survival; Progression free survival; Number of participants with adverse events; Identify specific virus-associated cancers as candidates for subsequent study; Measurement of Immuno-score; Measurement of MHC expression; Measurement of cell-free tumoral DNA in blood; Phenotyping of Tumour Infiltrating Lymphocytes; DNA viral load; Expression of lytic viral genes; Cytotoxic T-Lymphocyte immunophenotyping; T-cell receptor sequencing; Hsp90 concentration in serum AHS Cancer Control Alberta; EMD Serono All 18 Years and older (Adult, Older Adult) 39 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LATENT 02/07/2018 30/03/2022 26/02/2027 30/11/2017 07/05/2019 https://ClinicalTrials.gov/show/NCT03357757 Localised/Locoregional Hospital/University/Research Institute N N N Canada Multiple cancer types Other multiple cancer group (specify) Valproic Acid Safety and/or Dose; PFS; OS; Other (specify) Phase 2 DB00177 N
NCT02124174 Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS Recruiting Acute Myelogenous Leukemia AML|Myelodysplastic Syndrome MDS Drug: Vidaza and Valproic Acid Survival; Disease Relapse Patrick Stiff; Loyola University All 2 Years to 89 Years (Child, Adult, Older Adult) 50 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 203835 01/01/2012 01/01/2022 01/01/2022 28/04/2014 26/04/2021 https://ClinicalTrials.gov/show/NCT02124174 Advanced/Metastatic Hospital/University/Research Institute N N Y United States Leukemia; Other Haem-onc Acute Myeloid Leukemia, Adult; Acute Myeloid Leukemia, Childhood; Myelodysplastic Syndromes Valproic Acid OS; Recurrence rate Phase 2 DB00177 N
NCT02595138 Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer Active, not recruiting Triple Negative Breast Cancer Drug: Zoledronic acid disease free survival; overall survival; Number of Participants with Adverse Events as a Measure of Safety and Tolerability Chinese Academy of Medical Sciences; Beijing Municipal Science Technology Commission Female 18 Years and older (Adult, Older Adult) 430 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CH-BC-039 10/01/2015 10/01/2018 12/01/2023 11/03/2015 11/03/2015 https://ClinicalTrials.gov/show/NCT02595138 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Breast Cancer - TNBC Zoledronic Acid Safety and/or Dose; OS; DFS/RFS/EFS Phase 3 N
NCT03932071 Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma Recruiting Lung Metastases|Tumor Necrosis Drug: Zoledronic Acid rate of lung metastasis; rate of tumor recurrence; rate of tumor necrosis less than 90 Second Affiliated Hospital, School of Medicine, Zhejiang University All Child, Adult, Older Adult 150 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention ChiCTR-IPR-16008568 01/01/2017 01/01/2020 01/01/2023 30/04/2019 05/06/2019 https://ClinicalTrials.gov/show/NCT03932071 Localised/Locoregional Hospital/University/Research Institute Y N Y China Bone Sarcoma Osteosarcoma Zoledronic Acid Recurrence rate; Other (specify) Phase 4 N
2009-017137-22 Clinical course after substitution of Vitamin-D deficiency in patients with lung cancer or oesophageal carcinoma. Double blind randomised prospective, placebo-controlled study. Vitamin D3 in thoracic surgery Ongoing Patients admitted for treatment on a general thoracic surgery division with the following conditions: Lung cancer Esophageal cancer Cancer of the gastroesophageal junction (GEJ) Drug: Oleovit D3 Tropfen; Drug: Colecalciferol; Placebo Determination of the 25(OH)Vitamin D - levels in a patient collective requiring general thoracic surgery. The main hypothesis of the study is, that high-dose supplementation of vitamin D will reduce perioperative/periinterventional morbidity and mortality and will prolong survival or tumour-free survival in patients treated for lung cancer or oesophageal carcinoma. Klinische Abteilung f uuml;r Thorax -u. Hyperbare Chirurgie, Medizinische Universit auml;t Graz All Adult 18-64 400 - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017137-22/AT Perioperative Localised/Locoregional Hospital/University/Research Institute Y N N Austria Lung; GI Any lung cancers; Esophageal Cancer Cholecalciferol OS; DFS/RFS/EFS; Biomarker Phase 3 Not found in DrugBank N
2017-000695-28 Pilot study of Vitamin D biological effects in patients with resectable urinary tract urothelial carcinoma. Ongoing Patients with resectable urinary tract urothelial carcinoma candidates to radical cystectomy o nephroureterectomy. Drug: Colecalciferol (Vitamin D); Drug: COLECALCIFEROL Tumor expression of differentiation and Vitamin D response markers (RNA and protein), comparing pre- versus post- intervention with Vitamin D. Hospital Universitari Germans Trias i Pujol All Adult 18-64 50 Fundaci oacute;n Asociaci oacute;n Espa ntilde;ola contra el C aacute;ncer - https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000695-28/ES Localised/Locoregional Hospital/University/Research Institute N N N Spain Urological Bladder Cancer Cholecalciferol Biomarker Phase 4 Not found in DrugBank N
2019-002748-25 Repurposing disulfiram as treatment for metastatic colorectal cancer An investigator initiated clinical phase II trial Disulfiram colorectal cancer Ongoing Metastatic, non-resectable and irinotecan-resistant colorectal cancer Drug: disulfiram Primary objective: Disease-control rate (complete response, partial response and/or stable disease gt;= 18 weeks Department of Oncology, Odense Universitetshospital All Adult 18-64 28 Danish Cancer Society - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002748-25/DK Advanced/Metastatic Hospital/University/Research Institute N N N Denmark GI Colon Cancer; Rectal Cancer Disulfiram Other (specify) Phase 2 DB00843 N
2019-001972-12 A phase 1b/2 open-label, dose-escalating study of safety and efficacy of disulfiram, copper and vinorelbine in advanced solid tumors and advanced breast cancer Disulfiram trial Ongoing in phase 1b part: advanced and/or treatment refractory solid malignancies in phase 2 part : advanced or metastatic HER2-negative breast cancer Drug: disulfiram; Drug: vinorelbine Phase 1b: Safety and tolerability assessments include adverse event (AE), vital signs, physical examination, electrocardiogram (ECG) and clinical laboratory tests. Phase 2: clinical benefit rate (CBR=CR+PR+SD ge;18 weeks) per RECIST 1.1. Department of Oncology, Herlev amp; Gentofte Hospital All Adult 18-64 52 Danish Cancer Society - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001972-12/DK Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Denmark Multiple cancer types; Breast Any solid tumours; Breast Cancer - HER2- Disulfiram Safety and/or Dose; Response rate; Other (specify) Phase 1/2 DB00843 N
2019-000558-68 Phase II study of disulfiram and cisplatin in refractory testicular germ cell cancer. GCTSK006 Ongoing platina refractory testicular germ cell cancer Drug: cisplatina; Drug: DISULFIRAM Overall response rate (ORR) by RECIST 1.1 (intent-to-treat population) N aacute;rodn yacute; onkologick yacute; uacute;stav Male Adult 18-64 20 N aacute;rodn yacute; onkologick yacute; uacute;stav - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000558-68/SK Recurrent/Refractory Hospital/University/Research Institute N N N Slovakia Urological Testicular Cancer Disulfiram Response rate Phase 2 DB00843 N
2016-000089-45 A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study GB - no longer in EU/EEA Anaplastic Astrocytoma Drug: Eflornithine; Drug: Lomustine; Drug: EFLORNITHINE HYDROCHLORIDE The primary endpoint is the duration of overall survival as measured from the date of randomization. Orbus Therapeutics, Inc. All Adult 18-64 340 Orbus Therapeutics, Inc. - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000089-45/GB Palliative Recurrent/Refractory Company Y N N United States CNS Astrocytoma Eflornithine OS Phase 3 DB06210 N
2014-001523-69 Preclinical and clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of head and neck Valproic acid ndash; Cisplatin and Cetuximab in Head And Neck CancEr Ongoing Recurrent and/or metastatic squamous cell carcinoma of head and neck Drug: Valproic Acid; Drug: Erbitux; Drug: CETUXIMAB The overall response rate Istituto Nazionale Tumori di Napoli - Fondazione G. Pascale All Adult 18-64 39 Ricerca Corrente - Ministry of Health - https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-001523-69/IT Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Italy Head and Neck Any head and neck squamous cell carcinoma Valproic Acid Response rate Phase 2 DB00177 N
2014-004194-16 A multicenter, single-arm, phase II study to evaluate the activity of pre-operative zoledronate in triple negative breast cancer patients, according to p53 level TRIPLE NEGATIVE Ongoing Newly diagnosed, untreated, operable triple negative breast cancer The study is primarily aimed at assessing the anti-tumor activity of pre-operative zoledronate (zol), measured through its effect on the Ki67 proliferative surrogate biomarker, in patients with TNBC selected according to the p53 expression (high vs low p53 expression). Primary endpoint of the study is the proportion of responder patients, defined as those with at least 30 reduction in Ki67 at surgery with respect to core-biopsy analysis. Prior to enrolment, the FFPE diagnostic core biopsy specimens will be analyzed by the study pathologist to determine the presence of invasive TNBC and the Ki67/p53 values. The ki67/p53 evaluation will be then repeated after treatment at the time of definitive surgery. IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI All Adult 18-64 40 Associazione Italiana per la Ricerca sul Cancro - https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004194-16/IT Localised/Locoregional Hospital/University/Research Institute N N N Italy Breast Breast Cancer - TNBC Zoledronic Acid Biomarker Phase 2 N
2009-016932-11 Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with HER2-negative breast cancer. NEO-ZOTAC Ongoing Patients with locally advanced or large resectable HER2-negative breast cancer Drug: Zometa; Drug: pegfilgrastim The primary endpoint of this study is the pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery. BOOG Study Center B.V Female Adult 18-64 250 - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-016932-11/NL Neo-adjuvant/Window Localised/Locoregional Collaborative Group Y N N Netherlands Breast Breast Cancer - HER2- Zoledronic Acid Response rate Phase 3 N
2011-003154-12 Circulating Tumor Cells in Patients with Castration Resistant Metastatic Prostate Cancer Undergoing Zoledronate Therapy Cicero- Z Ongoing hormone refractory metastatic prostate cancer Drug: ZOLEDRONIC ACID Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid Privat auml;rztliche urologische Partnerschaft GbR, EuromedClinic Male Adult 18-64 60 Novartis - https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-003154-12/DE Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Germany Urological Prostate Cancer Zoledronic Acid Other (specify) Phase 4 N
2006-000426-31 STUDIO DI FASE I DELLA COMBINAZIONE FARMACOLOGICA TRA ACIDO ZOLEDRONICO E DOCETAXEL IN PAZIENTI CON CARCINOMA PROSTATICO METASTATICO ORMONO - REFRATTARIO ZANTE Ongoing carcinoma prostatico metastatico ormono refrattario Drug: Docetaxel middot; Determinare la dose massima tollerata (MTD) e la tossicita' dose-limitante (DLT) di DTX in due diverse sequenze di somministrazione con ZOL in pazienti affetti da carcinoma prostatico ormono-refrattario con metastasi ossee. ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE Male Adult 18-64; Elderly 65+ 36 - https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-000426-31/IT Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Italy Urological Prostate Cancer Zoledronic Acid Safety and/or Dose Phase 1/2 N
2013-001188-22 Interleukin 2 and zolendronic acid as maintaining treatment in multiple myeloma patients after autologous bone marrow transplant Ongoing Multiple Myeloma patients underwent to autologous bone marrow transplant Drug: zoledronic acid Clinical and laboratoristic progression of disease (onset or increase of monoclonal component, increased beta-2 microglobulin in two consecutive quarterly checks, progression of bone lesions, onset or progression of renal insufficiency). AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA All Adult 18-64 43 Regione Toscana e Ministero della Salute - https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001188-22/IT Any/All Stages Hospital/University/Research Institute N N N Italy Other Haem-onc Multiple Myeloma Zoledronic Acid PFS Phase 2 N
2019-004207-13 Tocotrienol and Bevacizumab in metastatic colorectal cancer. A randomized phase II marker trial Toco-CoR Ongoing Metastatic colorectal cancer Drug: Fluorouracil; Drug: Calciumfolinate; Drug: Bevacizumab; Drug: CALCIUM FOLINATE; Placebo The rate of progression free patients at six months Vejle Hospital All Adult 18-64 74 Vejle Hospital - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004207-13/DK Advanced/Metastatic Hospital/University/Research Institute Y N N Denmark GI Colon Cancer; Rectal Cancer Acetaminophen PFS Phase 2 DB00819 N
2012-002107-17 International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours Euro Ewing 2012 GB - no longer in EU/EEA Ewing's Sarcoma Family of Tumours Drug: Vincristine; Drug: Ifosfamide; Drug: Etoposide; Placebo Event-free survival (EFS) University of Birmingham All Under 18; Adult 18-64; Elderly 65+ 600 CTAAC - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-002107-17/GB Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N Y United Kingdom Bone Sarcoma Ewing Sarcoma Zoledronic Acid DFS/RFS/EFS Phase 3 N
2010-022104-50 A randomized phase II study of paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV non-squamous-non-small cell lung cancer: NVALT12 NVALT12 Ongoing metastatic non-squamous non-small-cell lung cancer Drug: Nitroglycerin transdermal patch Progression free survival. Stichting NVALT Studies All Adult 18-64 222 - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022104-50/NL Advanced/Metastatic Collaborative Group Y N N Netherlands Lung Non-Small Cell Lung Cancer Nitroglycerin PFS Phase 2 DB01422 N
2011-004062-15 Prospective, open label, randomized phase II trial to assess a multimodal molecular targeted therapy in children, adolescent and young adults with relapsed or refractory high risk neuroblastoma RIST-rNB-2011 Ongoing Relapsed or refractory high risk neuroblastoma Drug: Sprycel; Drug: Temodal; Drug: Irinotecan Kabi; Drug: DASATINIB; Drug: TEMOZOLOMIDE; Drug: IRINOTECAN; Drug: SIROLIMUS The primary endpoint is progression-free survival (PFS), which is defined as the time interval between randomization and date of progression (first time at which progression can be declared) according to bull; Imaging criteria (MRI, MIBG. CT, US) and/or bull; Bone marrow morphology or bull; date of death of any cause Patients with no progression until end of study or patients lost to follow up will be classified as censored cases at the latest date they will be confirmed to be progression free. University Hospital of Regensburg All Under 18; Elderly 65+ 114 Medac GmbH - Contolled|Randomised|Open|Cross over https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004062-15/AT Recurrent/Refractory Hospital/University/Research Institute Y N N Germany Other Neuroblastoma Sirolimus PFS Phase 2 DB01261 N
2012-001106-26 PHASE II MULTICENTRIC AND PROSPECTIVE TRIAL WITH GEMCITABINE AND RAPAMYCIN IN SECOND LINE OF METASTATIC OSTEOSARCOMA OSTEOSARCOMA METASTASICO PREVIOUSLY TREATED Ongoing Patients diagnosed with metastatic osteosarcoma cancer types that have been treated with chemotherapy and have active disease that permits to receive this treatment combination. Drug: GEMCITABINE HYDROCHLORIDE Analyze progression-free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated. JAVIER MART Iacute;N BROTO All Under 18; Adult 18-64 33 Direcci oacute;n General de Farmacia y Productos Sanitarios del Ministerio de Sanidad, Pol iacute;tica Social e Igualdad - https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-001106-26/ES Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Spain Bone Sarcoma Osteosarcoma Sirolimus PFS Phase 2 DB01261 N
ACTRN12616001350415 the efficacy of histone deacetylase inhibitor valproic acid in the treatment of gliomas Recruiting Brain Cancer;
Brain Cancer
;Cancer - Brain Addition of oral valproate (dose is epilepsy dose titrated to plasma concentration so changes) or placebo to standard care.
start dose is 15-20mg/kg, titrated in 100-200mg amounts depending on clinical status. Once daily until completion of second scan after chemotherapy/radiotherapy scan (3-4 months). VPA commences 4-5 days pre surgery to enable CSF samples at time of surgery. Blood concentrations to monitor adherence. F-DOPA and F-MISO PET uptake using standard PET measurement tool[After treatment completed. this includes the chemotherapy (Temozolamide and the RT) and is usually 3-4 months. As the original (standard) pre-op scan is not being done (as too much brain shift to interpret PET volumes accurately post op), the second scan, at the completion of chemo and radiotherapy is the primary time point.] RBWH All 18 Years: No limit 20 RBWH Foundation Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy; 01/01/2013 27/09/2016 13/01/2020 https://anzctr.org.au/ACTRN12616001350415.aspx Localised/Locoregional Hospital/University/Research Institute Y N N Australia CNS Glioblastoma Valproic Acid Other (specify) Phase 4 DB00177 N
ACTRN12615000778583 Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients Not yet recruiting Prostate cancer;
Prostate cancer;Cancer - Prostate;Metabolic and Endocrine - Metabolic disorders Metformin treatment over 6 weeks; oral tablets, dose - 500 mg twice daily for the first week, followed by 1000 mg twice daily from the second week for 5 weeks. Adherence monitored by empty tablet packet return. No washout between metformin and placebo, as study visits will be at baseline and at the end of each treatment. A composite primary outcome is serum IGF-1, IGF-2, IGFBPs (IGFBP-1 to 3) and bioactive IGF-1[Baseline and at 6 and 12 weeks] Western Sydney Local Health District Male 50 Years: 80 Years 26 Department of Endocrinology internal funds, UWS Blacktown Clinical School. Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy; 03/08/2015 27/07/2015 13/01/2020 https://anzctr.org.au/ACTRN12615000778583.aspx Localised/Locoregional Hospital/University/Research Institute Y N N Australia Urological Prostate Cancer Metformin Biomarker Phase 4 DB00703 N
ACTRN12607000082404 A pilot study to evaluate the feasibility, safety and tolerability of neoadjuvant triple therapy with zoledronic acid, docetaxel, and luteinising hormone-releasing hormone (LH-RH) analogue for men with high-risk prostate cancer to be treated by radical prostatectomy Not yet recruiting Prostate cancer;
Prostate cancer;Cancer - Prostate Docetaxel 75mgm/m2 intravenously every 3 weeks for 4 cycles.
Zoledronic acid 4mgm intravenously every 3 weeks for 4 cycles.
Goserelin acetate 10.5 mgm subcutaneously x 1 dose.
All administered prior to radical prostatectomy. Safety: haematology and biochemistry evaluation.[Weekly whilst receiving therapy, then 3/12 and 24/12 following radical prostatectomy.];Tolerability: assessment of adverse events.[Weekly during therapy, then 3/12 and 24/12 following radical prostatectomy.] Urology Department The Royal Melbourne Hospital Male 18 Years: No limit 15 The Royal Melbourne Hospital Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy; 01/04/2007 24/01/2007 13/01/2020 https://anzctr.org.au/ACTRN12607000082404.aspx Localised/Locoregional Hospital/University/Research Institute N N N Australia Urological Prostate Cancer Zoledronic Acid Safety and/or Dose Phase 2 N
ACTRN12606000079549 The LoPeZ study Recruiting Metastatic non-small cell lung carcinoma with bony metastases;
Metastatic non-small cell lung carcinoma with bony metastases;Cancer - Lung - Non small cell;Cancer - Bone Zoledronic acid, 4 mg intravenously monthly for six months The primary endpoint is the Visual metabolic response rate in asymptomatic non-osseous lesions[At 1 and 3 months, as determined by changes from baseline on [18F]-FDG PET/CT scans] Peter MacCallum Cancer Centre All 18 Years: Not stated 14 Novartis pharmaceuticals Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy; 06/02/2006 23/02/2006 13/01/2020 https://anzctr.org.au/ACTRN12606000079549.aspx Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Australia Lung Non-Small Cell Lung Cancer Zoledronic Acid Response rate Phase 2 N
ACTRN12611000301965 Immunomodulatory effect of anaesthetic technique in breast cancer surgery Not yet recruiting breast cancer;partial mastectomy with sentinel lymph node dissection;
breast cancer
partial mastectomy with sentinel lymph node dissection;Cancer - Breast;Anaesthesiology - Anaesthetics general anaesthesia with propofol 3 microg/ml, remifentanil 2 ng/ml in air (1 L/min) delivered at the same time with oxygen (1L/min) mixture and continuously maintained with propofol 3 microg/ml, remifentanil 2 ng/ml in air (1 L/min) delivered at the same time with oxygen (1L/ min) mixture during operation (approximately 90-120 minutes) activated T-cell panel (CD4/CD8/CD69/CTLA4) in peripheral blood will be evaluated using flow cytometry after monoclonal antibody staining[before anaesthetic induction, before discharge from the post anaesthesia care unit (PACU), 24 hour after end of operation];regulatory T cell subset(CD4/CD25/FoxP3) in peripheral blood will be evaluated using flow cytometry after monoclonal antibody staining[before anaesthetic induction, before discharge from the post anaesthesia care unit (PACU), 24 hour after end of operation] Jie Ae Kim Female 30 Years: 60 Years 60 Samsung Medical Center Clinical Research Development Program grant, CRS110-07-1 Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; 28/03/2011 22/03/2011 13/01/2020 https://anzctr.org.au/ACTRN12611000301965.aspx Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of Breast Any Breast Cancer Propofol Biomarker Phase 4 DB00571 N
ChiCTR2000038589 A multicenter, randomized, controlled clinical study of abiraterone combined with dutasteride in the treatment of castration-resistant prostate cancer Recruiting prostate cancer dutasteride+abiraterone:dutasteride+abiraterone;placebo+abiraterone:abiraterone; progression-free survival;PSA decrease range;overall survival;bone events;liver function; Shanghai Tongji Hospital Male - dutasteride+abiraterone:128;placebo+abiraterone:64; Shanghai Shenkang Hospital Development Center Interventional Study Parallel 17/09/2020 24/09/2020 30/11/2020 http://www.chictr.org.cn/showproj.aspx?proj=61685 Recurrent/Refractory Hospital/University/Research Institute Y N N China Urological Prostate Cancer Dutasteride Response rate; PFS; OS; Biomarker; Other (specify) Not available/Missing DB11742 N
ChiCTR2000037943 Metformin combined with FOLFIRI+bevacizumab in the second-line treatment of non-diabetic RAS mutant metastatic colorectal cancer: a multi-center, single-arm phase II clinical study Recruiting Colorecal cancer Single arm:Metformin; Effect;toxicity;Quality of Life; Sun Yat-Sen University Cancer Center All - Single arm:116; Sun Yat-sen University Cancer Center Clinical Research 308 Project Interventional Study Single arm 08/01/2020 09/04/2020 16/11/2020 http://www.chictr.org.cn/showproj.aspx?proj=60832 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Metformin Safety and/or Dose; Response rate; QoL Phase 2 DB00703 N
ChiCTR2000037740 A prospective study of dextromethorphan and metformin in treating patients with esophageal squamous cell carcinoma sufferering the failure of radiography and chemotherapy Recruiting esophageal squamous cell carcinoma Metformin treatment group:Metformin hydrochloride;Dextromethorphan treatment group:Dextromethorphan hydrobromide;Metformin and dextromethorphan treatment group:Metformin hydrochloride and Dextromethorphan hydrobromide;Placebo group:Placebo; Disease-free survival;Overall survival;CD44;SOX2;OCT4;a7nAchR;Inflammation marker;Immune cell marker;PD-L1;PD-1; Jinan University All - Metformin treatment group:150;Dextromethorphan treatment group:150;Metformin and dextromethorphan treatment group:150;Placebo group:150; Self-funding Interventional Study Parallel 15/09/2020 31/08/2020 11/02/2020 http://www.chictr.org.cn/showproj.aspx?proj=53770 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Head and Neck Any head and neck squamous cell carcinoma Metformin OS; DFS/RFS/EFS; Biomarker Not available/Missing DB00703 N
ChiCTR2000036618 Precision therapy strategy for osteosarcoma based on molecular typing: a prospective, single-center, one-brachial umbrella phase II exploratory clinical study Pending osteosarcoma A:Everolimus 5mg qd + Anlotinib 8mg-12mg day 1-21,28-day cycle;B:Camrelizumab 3mg/kg + Ipilimumab 1 mg/kg, 21-days cycle;C:Palbociclib 125mg day 1-21 + gemcitabine 600mg/m2 day 1,8,15,22, 28-days cycle;D:Olaparib 300mg bid day 1-14 + gemcitabine 600mg/m2 day 1,8,15,22, 28-days cycle;D:Metformin 2000mg qd + gemcitabine 675mg/m2 day 1,8, docetaxol 900mg/m2 day 8, 21-days cycle; Objective mitigation rate (ORR); Shanghai General Hospital All - A:3;B:3;C:4;D:4;D:4; Project special fund Interventional Study Factorial 10/01/2020 24/08/2020 21/09/2020 http://www.chictr.org.cn/showproj.aspx?proj=59675 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N China Bone Sarcoma Osteosarcoma Metformin Response rate Phase 2 DB00703 N
ChiCTR2000036467 A prospective single center study on the safety and efficacy of TACE + lovastatinib + PD1 monoclonal antibody in trans transplantation of hepatocellular carcinoma beyond Hangzhou standard Pending Hepatocellular carcinoma Experimental group:Combined intervention of PD-1 mAb + lovastatin + TACE;Control group:TACE intervention alone; disease free survival;CD4+ / CD8+ ratio; Huashan Hospital Affiliated to Fudan University All - Experimental group:30;Control group:30; Shanghai Shenkang Hospital Development Center Interventional Study Parallel 09/01/2020 23/08/2020 14/09/2020 http://www.chictr.org.cn/showproj.aspx?proj=59555 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Lovastatin DFS/RFS/EFS Not available/Missing DB09212 N
ChiCTR2000035935 The effect of local radical treatment on the breast cancer with bone oligometastasis Pending Breast cancer Experimental group:Surgery combined with radiofrequency ablation + Systemic anti-tumor therapy + bone repair therapy for breast cancer (4mg Zoleic acid vgtt q.m. / 6mg ibandronic acid vgtt q.m.);Control group:Systemic anti-tumor therapy + bone repair therapy for breast cancer (4mg Zoleic acid vgtt q.m. / 6mg ibandronic acid vgtt q.m.); Progression Free Survival; Shanghai Tenth People's Hospital Female - Experimental group:80;Control group:40; Hospital Development Center Interventional Study Parallel 01/01/2021 20/08/2020 24/08/2020 http://www.chictr.org.cn/showproj.aspx?proj=58950 Advanced/Metastatic Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Ibandronic Acid PFS Not available/Missing DB05266 N
ChiCTR2000035469 Effect of continuous intravenous infusion of lidocaine on postoperative recovery and long-term outcomes of patients with pancreatic cancer: A prospective, randomized controlled trial Pending Pancreatic cancer Lidocaine Group :Intravenous infusion of lidocaine;Control Group:Intravenous infusion of saline; Overall survival; Zhongshan Hospital, Fudan University All - Lidocaine Group :415;Control Group:415; National Natural Science Foundation of China 81871591 Interventional Study Parallel 09/01/2020 08/12/2020 17/08/2020 http://www.chictr.org.cn/showproj.aspx?proj=57569 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Pancreatic Cancer Lidocaine OS Not available/Missing DB08882 N
IRCT20120922010901N7 The effect of metformin in patients with ovarian cancer Recruiting Serum CA125 changes.
Elevated cancer antigen 125 [CA 125];R97.1 Intervention 1: Intervention group: Metformin starts with a daily dose of 500 mg and during one week the dose will be increased to 1500 mg daily in three divided doses (500 mg every 8 hours). This group will also receive carboplatin € paclitaxel periodically (every 21 days). Intervention 2: Control group: Will receive carboplatin € paclitaxel periodically (every 21 days). Response to treatment. Timepoint: Three months after the intervention. Method of measurement: Serum level of cancer antigen 125. Tabriz University of Medical Sciences Female 18 years: no limit 90 Tabriz University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using even and odd numbers, respectively. The number zero is considered as even. 22/07/2020 26/07/2020 17/08/2020 http://en.irct.ir/trial/49801 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Gynaecological Ovarian Epithelial Cancer Metformin Response rate Phase 3 DB00703 N
ChiCTR2000034678 Ascorbic acid (vitamin C tablets) enhances the efficacy of targeted drugs in advanced renal cell carcinoma: a multicenter randomized controlled trial Recruiting Renal cell carcinoma experimental group: Vitamin C tablets ;control group :Blank; Disease progression-free survival ; Affiliated Hospital of Qingdao University All - experimental group:59;control group :59; raise independently Interventional Study Parallel 07/01/2020 14/07/2020 20/07/2020 http://www.chictr.org.cn/showproj.aspx?proj=56452 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Urological Renal Cell Carcinoma Ascorbic acid DFS/RFS/EFS Phase 4 DB00335 N
ChiCTR2000034398 Gemcitabine plus nab-paclitaxel, paricalcitol and PD-1 antibody for locally advanced pancreatic cancer: a phase II, single center, single arm study Pending Pancreatic cancer experimental group:gemcitabine plus nab-paclitaxel, paricalcitol and PD-1 antibody; ORR; Sun Yat-Sen Cancer Center All - experimental group:21; Sponsored by the company Interventional Study Single arm 08/01/2020 07/04/2020 07/06/2020 http://www.chictr.org.cn/showproj.aspx?proj=56055 Localised/Locoregional Hospital/University/Research Institute N N N China GI Pancreatic Cancer Paricalcitol Response rate Phase 2 DB00715 N
ChiCTR2000034397 Gemcitabine, plus nab-paclitaxel, pirfenidone for pancreatic cancer with liver metastasis: a phase II, single center, single arm study Pending Pancreatic cancer experimental group:gemcitabine plus nab-paclitaxel, pirfenidone; ORR; Sun Yat-Sen Cancer Center All - experimental group:33; Sponsered by company Interventional Study Single arm 08/01/2020 07/04/2020 07/06/2020 http://www.chictr.org.cn/showproj.aspx?proj=56065 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Pancreatic Cancer Pirfenidone Response rate Phase 2 DB00554 N
KCT0005192 Identification of anti-tumor effect of propofol using microRNA profile analysis in patients undergoing lung cancer surgery Not yet recruiting ;Neoplasms Drug, Procedure/Surgery : Upon arrival at the operating room, patients #39; electrocardiogram, peripheral oxygen saturation (SpO2), non-invasive arterial pressure and bispectral index(BIS) are monitored. General anesthesia is induced and maintained with propofol and remifentanil in the propofol group. In the sevoflurane group, anesthesia is induced and maintained with sevoflurane inhalation and remifentanil. For maintenance of anesthesia, propofol effect site concentration is targeted 3-5 g/kg in the propofol group, and sevoflurane is administered 1-1.5 MAC in the sevoflurane group for maintaining BIS 40-60. Venous or arterial blood is drawn through intravenous or arterial catheter at the pre-operative time point and immediately before emergence from anesthesia. microRNA profile Hallym University Medical Center All 20(Year): 90(Year) 30 Hallym University Medical Center Interventional Study Primary Purpose : Basic Science, Intervention Model : Parallel, Blinding/Masking : Single, Blinding Target : Subject, Allocation : Not Applicable 13/07/2020 07/01/2020 13/07/2020 http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=17071 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of Lung Non-Small Cell Lung Cancer Propofol Biomarker Not available/Missing DB00571 N
ChiCTR2000034140 Study on Metformin Plus Temozolomide in Patient With Recurrent Glioblastoma Multiforme Pending Glioblastoma Multiforme Case series:Metformin Plus Temozolomide; Progression Free Survival; Sun Yat-sen University Cancer Center All - Case series:67; Sun Yat-sen University Cancer Center 308 Plan Interventional Study Single arm 06/01/2019 26/06/2020 29/06/2020 http://www.chictr.org.cn/showproj.aspx?proj=49143 Recurrent/Refractory Hospital/University/Research Institute N N N China CNS Glioblastoma Metformin PFS Phase 1/2 DB00703 N
ChiCTR2000034035 Five-year prognosis of postmenopausal patients with hormone receptor-positive early breast cancer treated with different stains and aromatase inhibitors: a prospective, randomized controlled trial Pending Breast Cancer Lipophilic stain simvastatin treatment:Simvastatin;Hydrophilic stain simvastatin treatment:Pravastatin; 5-year relapse-free survival; The First Hospital of China Medical University Female 50: 70 Lipophilic stain simvastatin treatment:187;Hydrophilic stain simvastatin treatment:187; self-raised Interventional Study Parallel 15/07/2020 21/06/2020 22/06/2020 http://www.chictr.org.cn/showproj.aspx?proj=55473 Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Breast Cancer - ER/HR+ Pravastatin; Simvastatin DFS/RFS/EFS Phase 4 DB00457; DB00877 N
IRCT20200313046756N1 Vitamin D, Probiotics and Breast Cancer Recruiting Breast Cancer. Intervention 1: Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a single oral capsule, with food, and with a probiotic placebo capsule for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention 2: Intervention group: Patients who receive single probiotics capsule daily at 1 billion CFU before meals with a single vitamin D3 placebo capsule for at least 16 weeks from cancer diagnosis until surgery. Intervention 3: Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a capsule, with food and probiotic capsules daily with 1 billion CFU for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention 4: Intervention group: Patients who receive one vitamin D3 placebo capsule with food and one probiotic placebo capsule daily before meals for 16 consecutive weeks from breast cancer diagnosis until surgery. Measurement of Miller-Payne Grade Index on Residual Tumor Tissue. Timepoint: 4 months after intervention. Method of measurement: Microscopic examination.;Residual Cancer Burden Score on residual tumor tissue. Timepoint: 4 months after intervention. Method of measurement: By http://www.mdanderson.org/breastcancer_RCB.;Ki-67 nuclear protein as a biomarker of cell proliferation. Timepoint: ?At the beginning of the intervention, by Core needle biopsy and 4 months later (after surgery) on the residual tumor tissue. Method of measurement: Immunohistochemical staining. Kerman University of Medical Sciences Female 18 years: no limit 88 Kerman University of Medical Sciences;Zist Takhmir Pharmaceutical Company Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients will be divided into four intervention groups by the factorial method.Randomization Method: FactorialRandomization Unit: PersonRandomization Tool: Random Number Table, Blinding description: People will be kept blind.1. Patients: Each patient will receive a label according to the random number table that will appear on the patient's drug box. Medicines do not differ in appearance, taste, odor. The patient consumes two capsules daily.2. Physician: The analyzing team will give the medicine boxes to the physician, and the physician will provide the medication based on the random number table. 04/08/2020 28/03/2020 21/04/2020 http://en.irct.ir/trial/46512 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y Y N Iran Breast Any Breast Cancer Calcipotriol; Calcitriol; Cholecalciferol Response rate; Biomarker Phase 3 DB00136; DB08907; Not found in DrugBank N
KCT0004674 Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients Not yet recruiting ;Neoplasms Drug : Aspirin arm: Daily oral aspirin 100 mg for 5 years
Placebo arm: Daily oral placebo for 5 years The incidence of gastric cancer between the intervention and placebo groups National Cancer Center All 19(Year): 70(Year) 1700 National Cancer Center Interventional Study Primary Purpose : Prevention, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Outcome Accessor, Allocation : RCT NCT04214990 19/02/2020 30/01/2020 24/02/2020 http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14998 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Gastric Cancer Acetylsalicylic Acid Recurrence rate Phase 3 DB01048 N
ChiCTR2000029245 The efficacy and safety of the combination of transcatheter arterial chemoembolisation with metronidazole in hepatocellular carcinoma Pending Hepatocellular carcinoma experimental group:TACE combined with Metronidazole;control group:TACE; Survival rate at 1-year; Beijing Ditan Hospital, Capital Medical University All - experimental group:116;control group:116; Beijing Talents Project Interventional Study Parallel 03/01/2020 20/01/2020 20/01/2020 http://www.chictr.org.cn/showproj.aspx?proj=47069 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Metronidazole OS Other DB01011 N
ChiCTR2000028905 Metformin for chemoradiotherapy prevention in advanced nasopharyngeal carcinoma patients: a double-blind, placebo-controlled, randomized clinical trial Pending nasopharyngeal carcinoma Treatment group:Metformin and chemoradiotherapy;Control group:Placebo and chemoradiotherapy; Progression free survival; Hunan Cancer Hospital All - Treatment group:101;Control group:101; National Natural Science Foundation of China (No.81874329) Interventional Study Parallel 03/01/2020 01/06/2020 13/01/2020 http://www.chictr.org.cn/showproj.aspx?proj=48015 Advanced/Metastatic Hospital/University/Research Institute Y N N China Head and Neck Nasopharyngeal Cancer Metformin PFS Phase 4 DB00703 N
KCT0004571 Phase II trial evaluating the efficacy and safety of physician chosen chemotherapy with hormonal therapy in patients with heavily pretreated advanced ovarian cancer: A multicenter pilot study Recruiting ;Neoplasms Drug : Receptor status is assessed by immunohistochemistry using recurrent tissues obtained from biopsy as determined by central laboratory. Dominant receptor, which means the receptor that has the highest expression, will be determined and hormonal therapeutic agent for the dominant receptor will be selected. In addition to chemotherapy, ER dominant EOC patients will be treated with tamoxifen 40 mg (20mg, bid, oral), daily and PR dominant patients will be treated with megestrol acetate 160mg (once, oral), daily. Hormonal therapies are performed from day 1 of 1st cycle of chemotherapy until progression of disease or unacceptable toxicity. objective response rate Inha University Hospital Female 19(Year): No Limit 58 Dalim BioTech Interventional Study Primary Purpose : Other(To evaluate the efficacy and safety of combination therapy of various types of physician chosen chemotherapy and tailored targeting hormonal therapies in patients with heavily pretreated advanced OC), Intervention Model : Parallel, Blinding/Masking : Open, Allocation : Non-RCT 11/08/2019 20/12/2019 14/01/2020 http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14535 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N Korea, Republic of Gynaecological Ovarian Epithelial Cancer; Fallopian Tube Cancer Megestrol Acetate Response rate Phase 2 DB01065 N
IRCT20191203045594N1 The effect of metformin on treatment of squamous cell carcinoma of neck Pending Malignant neoplasm of larynx.
Malignant neoplasm of larynx, unspecified;C32.9 Intervention group: The patients with proven diagnosis of squamous cell carcinoma of hypopharynx, nasopharynx, and larynx receiving concurrent chemoradiation will take metformin orally twice daily (1000 mg/day) after eating from 7 to 11 days prior chemoradiotherapy until the end of it. The complete response. Timepoint: 12 weeks after the intervention. Method of measurement: Spiral CT scan.;Toxicity. Timepoint: Weekly. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE). Shiraz University of Medical Sciences All 18 years: 75 years 25 Shiraz University of Medical Sciences Interventional Study Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 18/12/2019 12/12/2019 17/12/2019 http://en.irct.ir/trial/43982 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N Iran Head and Neck Any head and neck squamous cell carcinoma Metformin Response rate Phase 2 DB00703 N
ChiCTR1900026213 Effect of optimized thoracic paravertebral nerve block on early and rapid recovery and long-term clinical outcome of radical lung cancer patients Recruiting Lung Cancer Sevoflurane:Sevoflurane;Sevoflurane+TPVB:Sevoflurane+TPVB;Sevoflurane+Optimized TPVB:Sevoflurane+Optimized TPVB;Propfol:Propofol;Propofol+TPVB:Propofol+TPVB;Propofol+Optimized TPVB:Propofol+Optimized TPVB; Stay duration in hospital; Henan Provincial People's Hospital All - Sevoflurane:55;Sevoflurane+TPVB:55;Sevoflurane+Optimized TPVB:55;Propfol:55;Propofol+TPVB:55;Propofol+Optimized TPVB:55; Self-raised Interventional Study Parallel 10/01/2019 26/09/2019 30/09/2019 http://www.chictr.org.cn/showproj.aspx?proj=43733 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Propofol PFS; OS; Biomarker; Other (specify) Not available/Missing DB00571 N
KCT0004236 Effect of adjunctive metformin on recurrence of non-DM colorectal cancer Recruiting ;Neoplasms Drug : This study is an open label randomized controlled clinical trial to examine the effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer. The 1g/day of metformin will be given to patients during adjuvant chemotherapy after surgery and continued for 4 years. recurrence rate Yonsei University Health System, Severance Hospital All 20(Year): 80(Year) 593 Yonsei University Health System, Severance Hospital Interventional Study Primary Purpose : Prevention, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT 07/08/2016 23/08/2019 12/02/2020 http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18121 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Colon Cancer; Rectal Cancer Metformin Recurrence rate Phase 2 DB00703 N
IRCT20190726044335N1 Therapeutic effect of metformin in rectal cancer Recruiting Rectal cancer.
Malignant neoplasm of rectum Intervention 1: Intervention group: The patients with rectal cancer in the case group will be taken the metformin 500 mg Po Bid after eating and taking into account the contraindications. Intervention 2: Control group: The patients with rectal cancer in the control group will not be taken the metformin. Pathologic complete response. Timepoint: Post operation. Method of measurement: Pathologic examination. Shiraz University of Medical Sciences All 18 years: 75 years 90 Shiraz University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random numbers table, Blinding description: The patient will not be unaware of the medication content. 23/08/2019 20/08/2019 10/07/2019 http://en.irct.ir/trial/41127 Localised/Locoregional Hospital/University/Research Institute Y N N Iran GI Rectal Cancer Metformin Response rate Phase 2 DB00703 N
KCT0003946 The Identification of the Safety and Efficacy of Tadalafil for the Suppression of Recurrence of Hepatocellular Carcinoma Recruiting ;Neoplasms Drug : Subjects will take a dose of 20mg of tadalafil once daily at 10 PM, and the therapy will last for one year. Toxicities of grade 3 or higher Seoul National University Hospital Male 19(Year): No Limit 24 Daewoong Research Development Center Interventional Study Primary Purpose : Treatment, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable 22/05/2019 20/05/2019 17/06/2019 http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14056 Localised/Locoregional Hospital/University/Research Institute N N N Korea, Republic of GI Liver Cancer Tadalafil Safety and/or Dose Phase 1/2 DB01079 N
ChiCTR1900021896 Prospective study for pd-1 inhibitor combined with liquid biopsy ctDNA detection combined with targeted drugs in the treatment of advanced unresectable liver cancer patients Recruiting hepatocelluar carcinoma Opdivo+targeted drug:Once every 2 weeks Opdivo drug therapy, medicine according to the 3 mg/kg body weight calculation Opdivo dose, intravenous drug. Using the technology of liquid biopsy ctDNA for gene mutation to screen suitable targeted drug including sorafenib, Lomatinib, Apatinib and sirolimus.other drugs including COX2 inhibitor aspi;Keytruda+targeted drug:The Keytruda drug treatment group will be given Keytruda drug treatment once every three weeks, with a dose of 200mg, usage and precautions the same as Opdivo drug. intravenous drug.Using the technology of liquid biopsy ctDNA for gene mutation to screen suitable targeted drug including sorafenib, Lomatinib, Apa; Objective response rate;Duration of response;Progression-free survival;Overall survival; The Third Affiliated Hospital of Sun Yat-sen University All - Opdivo+targeted drug:25;Keytruda+targeted drug:25; Researcher afford Interventional Study Case-Control study 12/01/2018 15/03/2019 18/03/2019 http://www.chictr.org.cn/showproj.aspx?proj=34506 Advanced/Metastatic Hospital/University/Research Institute N Y N China GI Liver Cancer Sirolimus Response rate; PFS; OS; Other (specify) Phase 4 DB01261 N
ChiCTR1900021641 A randomized controlled trial for the effect of metformin on prognosis in patients with oral cancer Pending oral cancer Experimental group:surgery + postoperative Metformin;Control group:surgury; Whether recurrence; Xiangya Hospital, Central South University All - Experimental group:73;Control group:73; Provincial planning project: B2017003, clinical and basic research on prevention and treatment of oral cancer recurrence of metformin; National Natural Science Foundation of China: 81837317, DEC1 Interventional Study Parallel 20/03/2019 03/02/2019 03/04/2019 http://www.chictr.org.cn/showproj.aspx?proj=35809 Localised/Locoregional Hospital/University/Research Institute Y N N China Head and Neck Oropharyngeal Cancer Metformin Recurrence rate Not available/Missing DB00703 N
ChiCTR1900021426 Effects of flurbiprofen on immune function in patients under radical operation for colon carcinoma Pending colon cancer FA+FA group:Flurbiprofen axetil 50mg i.v. before induction;FA+FA group:PCA with Sufentanil 1 g/kg +Flurbiprofen axetil 300mg+Tropisetron 10mg; Changes in perioperative immune-related cells, including: number of CD4+, CD8+ and NK cells, CD4+/CD8+ ratio; Affiliated Hospital of Xuzhou Medical University All - FA+FA group:75;FA+FA group:75; BEIJING TIDE PHRAMACEUTICAL CO.,LTD Interventional Study Parallel 03/01/2019 21/02/2019 25/02/2019 http://www.chictr.org.cn/showproj.aspx?proj=36161 Localised/Locoregional Hospital/University/Research Institute N Y N China GI Colon Cancer Flurbiprofen Biomarker Phase 4 DB04842 N
ChiCTR1900020701 A randomized controlled trial for intra-arterial infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy for unresectable gastric cancer Recruiting gastric cancer Group 1:Systemic chemotherapy plus oral chemotherapy group;Group 2:Arterial catheter infusion chemotherapy plus oral chemotherapy;Group 3:Arterial catheter infusion chemotherapy + oral chemotherapy + sodium bicarbonate; Successful conversion rate of operation; The Second affiliated Hospital, Zhejiang University School of Medicine All - Group 1:50;Group 2:50;Group 3:50; cientific research project of Zhejiang Province Interventional Study Randomized parallel controlled trial 01/01/2019 14/01/2019 28/01/2019 http://www.chictr.org.cn/showproj.aspx?proj=34916 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y Y N China GI Gastric Cancer Sodium Bicarbonate Other (specify) Not available/Missing DB00421 N
ChiCTR1800020425 Effects of total intravenous anesthesia and inhalation anesthesia on the prognosis of patients with endoscopic lung cancer Recruiting lung canser Group 1:Propofol intravenous combined general anesthesia;Group 2:Sevoflurane inhalation combined general anesthesia;Group 3:Propofol intravenous + sevoflurane inhalation combined general anesthesia; Secrete body outside;Micro vesicles;CD151;CD171;microRNA-10b-5p;microRNA-212-3p;microRNA-21-5p;IL-1;IL-6;IL-10;TNF-a;Total T-lymphocyte;Thlymphocyte;Tslymphocyte;NK cell;B lymphocyte;Cancer cells in the blood;Hydrothorax cancer cell;Total anesthesia drugs;Tumor marker;PET-CT;The pathologic types;Clinical staging;Tumor recurrence time;Time of distant metastasis; Affiliated Cancer Hospital of Guangxi Medical University All - Group 1:30;Group 2:30;Group 3:30; Affiliated Cancer Hospital of Guangxi Medical University Interventional Study Randomized parallel controlled trial 01/01/2019 29/12/2018 14/01/2019 http://www.chictr.org.cn/showproj.aspx?proj=34334 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Propofol PFS; OS; Biomarker Not available/Missing DB00571 N
ChiCTR1800016053 Effect of Ultrasound-guided thoracic paravertebral block on perioperative analgesia and tumor immune function in patients of video-assisted lung cancer surgery Recruiting lung cancer Experience group:thoracic paravertebral block + propofol general anesthesia;Control group:opioid + sevoflurane general anesthesia; pain score;opioid consumption;the number ofCD4+/CD8+ T and PD-1;VEGF;MMP-2; Third Affiliated Hospital of Army Medical University (Field Surgery Institute) All 40: 80 Experience group:50;Control group:50; self-collected Interventional Study Randomized parallel controlled trial 05/01/2018 05/08/2018 14/05/2018 http://www.chictr.org.cn/showproj.aspx?proj=21590 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Propofol Biomarker Not available/Missing DB00571 N
ChiCTR1800015808 Pilot Clinical Study of Chemo-Cocktail (TTF) for Recurrent Glioblastoma Recruiting Recurrent Glioblastoma TTF:temmozoldmide+tranilast+fasudil; Survival time;Survival time;Patient condition;Monitoring of blood, cerebrospinal fluid;Neuroimaging examination; Huashan Hospital, Fudan University All - TTF:10; No Treatment Study Case series 05/01/2018 22/04/2018 30/04/2018 http://www.chictr.org.cn/showproj.aspx?proj=25630 Recurrent/Refractory Hospital/University/Research Institute N N N China CNS Glioblastoma Fasudil; Tranilast OS Phase 1 DB01023; DB00752 N
ChiCTR1800015510 A single-arm exploratory trail of combination of abiraterone with dutasteride in the treatment of abiraterone resistant CRPC Temporary halt prostate cancer single arm:abiraterone+ dutasteride+ prednisone; progression-free survival; Shanghai Tongji Hospital Male - single arm:50; scientific research grands of Shanghai Tongji Hospital Interventional Study Single arm 06/01/2018 04/04/2018 16/02/2021 http://www.chictr.org.cn/showproj.aspx?proj=26413 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China Urological Prostate Cancer Dutasteride PFS Not available/Missing DB11742 N
IRCT20170314033080N2 Effect of losartan with whole bain radiotherapy in brain metastasis Recruiting Brain metastasis.
Malignant neoplasm of brain Intervention 1: Intervention group: whole brain radiation with 30 Gray in 10 fractions and using 25 mg losartan tablet during radition course. Intervention 2: Control group: standard treatment with whole brain radiation with 30 Gray in 10 fractions and using placebo during radiation course. Radiologic response of brain metastatic lesion. Timepoint: 6 weeks after ending of intervention. Method of measurement: RECIST V1.1criteria for response evaluation in solid tumors. Ahvaz Jundi Shapour university of Medical Science All 18 years: 90 years 60 Ahvaz Jundi Shapour university of Medical Science Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals randomly divided to two groups based on fourth permutation blocks, so that reasercher do not interfere with the allocation of treatment methods to patients, Blinding description: Participants in study which are patients with brain metastasis, after being informed about attending in a clinical study and obtaining consent, are unaware that they are taking Losartan pill in addition to standard radiotherapy or placebo. The researcher and the evaluator of outcome is also unaware which groups is taking drug and which group taking placebo. 21/03/2018 03/11/2018 26/03/2018 http://en.irct.ir/trial/25613 Advanced/Metastatic Hospital/University/Research Institute Y N N Iran Multiple cancer types Any solid tumours Losartan Response rate Phase 2 DB00227 N
ChiCTR1800014946 Thalidomide, Clarithromycin and Dexamethasone Regimen for Patients With Newly Diagnosed Multiple Myeloma Recruiting Multiple Myeloma Case series:Thalidomide, Clarithromycin and Dexamethasone; Percentage of participants with very good partial remission (VGPR) or better; Bejing Chaoyang Hospital All - Case series:37; Key Medical Program of Full Sail Plan of Beijing Municipal Administration of Hospitals: Multiple Myeloma Treatment Study Cohort study 03/01/2018 24/02/2018 26/02/2018 http://www.chictr.org.cn/showproj.aspx?proj=25260 Localised/Locoregional Hospital/University/Research Institute N N N China Other Haem-onc Multiple Myeloma Clarithromycin Response rate Other DB00283 N
ChiCTR-IPR-17013973 The effect of Metformin combine with FOLFOX + Bevacizumab as the first-line therapy in metastatic colorectal cancer, a randomized, open, prospective clinical study (BeFoLMe study) Pending Colorectal Cancer;C18.9,C20 Study Group:Metformin 250mg per day combine with FOLFOX + Bevacizumab;Control Group:FOLFOX + Bevacizumab; PFS, Progression-Free-Survival; Xiangya Hospital, Central South University All - Study Group:20;Control Group:20; Xiangya Hospital, Central South University Interventional Study Randomized parallel controlled trial 01/01/2018 15/12/2017 18/12/2017 http://www.chictr.org.cn/showproj.aspx?proj=23560 Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metformin PFS Phase 4 DB00703 N
ChiCTR-IOR-17011859 The Exploration of the Efficacy of Metformin Combined with First-line Chemotherapy for the Treatment of Ovarian Cancer Recruiting ovarian cancer optimal cytoreductive surgery group:TC;optimal cytoreductive surgery group:TC+metformin;non-optimal cytoreductive surgery group:TC;non-optimal cytoreductive surgery group? :TC+metformin; response rate;progression free survival; Obstetrics and Gynecology Hospital of Fudan University Female - optimal cytoreductive surgery group:20;optimal cytoreductive surgery group:20;non-optimal cytoreductive surgery group:20;non-optimal cytoreductive surgery group? :20; Science and Technology Commission of Shanghai Municipality (16411963600) Interventional Study Randomized parallel controlled trial 07/01/2016 07/04/2017 07/10/2017 http://www.chictr.org.cn/showproj.aspx?proj=20252 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Ovarian Epithelial Cancer Metformin Response rate; PFS Other DB00703 N
ChiCTR-IOR-17010695 The significance of minimal residual disease exmination on the multiple myeloma maintain treatment Pending Multiple myeloma maintain treatment:thalidomide and Clarithromycin;Observation:Observation; Progression Free Survival; Shanghai Changzheng Hospital All - maintain treatment:300;Observation:300; National Natural Science Foundation of China. Project approval number 30828017 Interventional Study Randomized parallel controlled trial 04/01/2017 21/02/2017 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=18048 Localised/Locoregional Hospital/University/Research Institute Y N N China Other Haem-onc Multiple Myeloma Clarithromycin PFS Other DB00283 N
IRCT2015112725256N1 Effect of Metformin on Glioblastoma Multiform Recruiting Glioblastom multiform.
Brain, unspecified;Brain, unspecified Intervention 1: Intervention Group will receive radiotherapy plus Temozolomide and Metformin 1g daily. The patients should take Metformin durng radiotherapy and after that till primay endpoint. Intervention 2: Control Group will receive radiotherapy and Temozolomide as routine adjuvant treatment.;Treatment - Drugs;Treatment - Drugs;Intervention Group will receive radiotherapy plus Temozolomide and Metformin 1g daily. The patients should take Metformin durng radiotherapy and after that till primay endpoint.;Control Group will receive radiotherapy and Temozolomide as routine adjuvant treatment. Overall survival. Timepoint: monthly. Method of measurement: alive or dead. Kerman Neuroscience Research Center All 18 years: no limit 60 Kerman Neuroscience Research Center Interventional Study Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 22/07/2016 08/04/2016 22/02/2018 http://en.irct.ir/trial/21147 Localised/Locoregional Hospital/University/Research Institute Y N N Iran CNS Glioblastoma Metformin OS Phase 2 DB00703 N
ChiCTR-IPR-16008553 Clinical study on the anti-cancer effect of metformin in the breast cancer patients with prediabetes during neoadjuvant chemotherapy. Pending breast cancer;prediabetes;diabetes Group 1:placebo;Group 2:metformin,850mg,Bid.; Pathologic complete response(PCR); Department of Endocrine and Breast Surgery of the First Affiliated Hospital of Chongqing Medical University Female - Group 1:250;Group 2:250; The metformin manufacturer provides financial assistance Interventional Study Randomized parallel controlled trial 30/06/2016 28/05/2016 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=14483 Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Metformin Response rate Phase 4 DB00703 N
ChiCTR-IPR-16008128 Effects of two types of anesthesia maintenance on body immunity and malignant behaviours of patients after cancer surgery Recruiting Malignant solid tumors Sevoflurane groupin in each tumor type:Sevoflurane for inhalation;Propofol groupin in each tumor type:Propofol for injection; The expression of hypoxia-induced molecules; Peking University First Hospital All - Sevoflurane groupin in each tumor type:30;Propofol groupin in each tumor type:30; Self-prepare Interventional Study Randomized parallel controlled trial 22/03/2016 22/03/2016 27/11/2017 http://www.chictr.org.cn/showproj.aspx?proj=13760 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Any solid tumours Propofol Biomarker Not available/Missing DB00571 N
ChiCTR-IPR-16008078 Effect of ulinastatin on clinical outcomes of patients with advanced lung cancer resection via thoracotomy Recruiting lung cancer U:continuously intravenously infusion ulinastatin;C:NS; postoperative pulmonary complications;hospital mortality;recurrence and metastasis rate;rate of survival; Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, Sichuan, China. All - U:120;C:120; Techpool Fund Interventional Study Randomized parallel controlled trial 06/01/2015 03/10/2016 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=12894 Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Any lung cancers Ulinastatin Safety and/or Dose; OS; Recurrence rate Phase 4 DB01586 N
ChiCTR-IIR-16007908 Zoledronate combinate with gefitinib in advanced non-small cell lung cancer with EGFR activation mutation: a multicenter, randomised controlled, phase II trial. Recruiting non small lung cancer Experimental group:Gefitinib and zoledronate. zoledronate 4 mg intravenous (IV) monthly +Gefitinib 250mg orally (PO) daily.Placebo Comparator: Arm B Gefitinib and placebo. Placebo was given to patients in the same way as that of zoledronate in Arm A.;Placebo Comparator:Gefitinib and placebo. Placebo was given to patients in the same way as that of zoledronate; Progression-free survival (PFS) of the patients.; Enshi Tujia and Miao Autonomous Prefecture Central Hospital All - Experimental group:25;Placebo Comparator:25; self-collected Interventional Study Randomized parallel controlled trial 02/05/2016 02/06/2016 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=13357 Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Zoledronic Acid PFS Phase 2 N
ChiCTR-IIR-16007801 Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer Recruiting non small cell lung cancer treatment group:vitamin C infusion;treatment group:Electro-Hyperthermia;treatment group:Lifestyle counseling ;control group:Lifestyle counseling ; Safety of vitamin C infusion in combination with oncothermia on NSCLC patients; CLIFFORD HOSPITAL All - treatment group:35;treatment group:35;treatment group:35;control group:35; CLIFFORD HOSPITAL Interventional Study Randomized parallel controlled trial 20/01/2016 20/01/2016 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=13023 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Ascorbic acid Safety and/or Dose; PFS; Biomarker Phase 1/2 DB00335 N
ChiCTR-IPR-15006066 Clinical research of chemotherapy consisted of temozolomide with concomitant sodium valproate and nicardipine for Glioma Pending glioma Standard Chemoradiotherapy :TMZ;TMZ+Nicardipine+Sodium Valproate:TMZ+Nicardipine+Sodium Valproate; KPS score;WHO tumor objective curative effect evaluation;survival time; Department of Neurosurgery, The Second Affiliated Hospital of Suzhou University All - Standard Chemoradiotherapy :20;TMZ+Nicardipine+Sodium Valproate:20; Chinese Anti Cancer Association Fund Interventional Study Randomized parallel controlled trial 03/01/2015 03/11/2015 18/04/2017 http://www.chictr.org.cn/showproj.aspx?proj=10540 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute Y N N China CNS Glioma Nicardipine; Valproic Acid Safety and/or Dose; OS; QoL Other DB06803; DB00177 N
CTRI/2012/07/002802 Metformin in Triple Negative Operable or Locally Advanced Breast cancer Open to Recruitment Health Condition 1: null- Locally advanced or Large Operable Breast cancer patients with Triple Negative hormone receptor status. Intervention1: Tab.Metformin 500mg OD: Patient randomised on Tab.Metformin plus taxane based chemotherapy arm will received Tab.metformin 500mg OD 7 days prior to chemotherapy 1st cycle till completion of 8 chemotherapy cycles.
Control Intervention1: Taxane/ Platinum based chemotherapy: Patient randomised on taxane/Platinum based chemotherapy will received 8 cycles of chemotherapy in neo adjuvant setting before surgery
Control Intervention2: Taxane and Platinum based chemotherapy: Patient randomized on taxane plus platinum based chemotherapy will receive 8 cycles of taxane plus platinum based chemotherapy in neo adjuvant setting before surgery
To see the effect of platinum based chemotherapy and metformin on disease free and overall survival and response rates in triple negative breast cancer.Timepoint: 5 years after completion of accrual Tata Memorial Centre - - 800 Tata Memorial Centre Interventional Study Randomized Factorial Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Other Blinding and masking:Open Label 02/04/2010 16/07/2012 27/01/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4759 Neo-adjuvant/Window Localised/Locoregional Hospital/University/Research Institute Y Y N India Breast Breast Cancer - TNBC Metformin OS; DFS/RFS/EFS Phase 3 DB00703 N
ACTRN12620000815965 Phase II Trial of Doxycycline with Radiotherapy for Rectal Cancer Not yet recruiting Rectal Cancer;
Rectal Cancer;Cancer - Bowel - Back passage (rectum) or large bowel (colon) Doxycycline is a broad-spectrum antibiotic, which prevents the binding of amino-acyltRNA to the messenger RNA-30S ribosomal subunit, preventing polyribosome formation. It is approved in New Zealand for the treatment of chronic prostatitis, sinusitis, syphilis, pelvic inflammatory disease, malaria, recurrent aphthous ulceration, and acne vulgaris. Doxycycline primarily exerts it's antimicrobial action by bacteriostasis. It also has antinflammatory effects.
Doxycycline will be administered as two 100mg tablets orally each morning, starting two days prior to the first dose of short-course radiotherapy (SCRT), until one day prior to surgery for rectal cancer. Surgery will be performed within three weeks of starting radiotherapy treatment. The duration of doxycycline will be between 12 and 23 days, and will be determined by each participant s individual treatment schedule.
Adherence will be assessed through a combination of a patient diary, and count of the number of tablets remaining in the drug container on the patients admission for rectal cancer surgery. Difference in the mean immunohistochemistry (IHC) H-scores for CD133 in resected tumours between the doxycycline and control groups.[Based on rectal cancers surgically resected within 3 weeks of radiotherapy.] Dr Natalie Briggs All 18 Years: No limit 40 Waikato Medical Research Foundation Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Type of endpoint: Safety/efficacy; 17/08/2020 14/08/2020 24/08/2020 https://anzctr.org.au/ACTRN12620000815965.aspx Localised/Locoregional Hospital/University/Research Institute N N N New Zealand GI Rectal Cancer Doxycycline Biomarker Phase 2 DB04855 N
ACTRN12612000852853 Preventing Colorectal Cancer Metastases following Surgical Removal of a Primary Tumor Recruiting Colorectal cancer;
Colorectal cancer;Cancer - Bowel - Back passage (rectum) or large bowel (colon) In the current study we aim at testing the safety and efficacy of our drug cocktail in patients undergoing excision of colorectal cancer. Both short-term outcomes (immune and endocrine indices), as well as 3-year recurrence rates will be assessed within patients. Specifically, we propose a double blind clinical trial with two major arms: (I) placebo treatment, and (II) treatment with a cocktail of a B-blocker (propranolol € to block catecholamines, oral tablet 40 mg , 3 times daily) and a COX2 inhibitor (etodolac € to block prostaglandin receptors, 200 mg oral tablets every 6 hours ). A total of 206 patients will be recruited. The drug treatment will be given for a total of 20-day period, commencing five days before surgery, with no time overlap with adjuvant therapy, and independently of any other routine therapy. The drug treatment is planned for only 15 post-operative days to reduce potential side effects, and because most immunological and endocrine perturbations induced by surgery dissipate during this period. Immune and endocrine baseline levels will be established in a group of thirty healthy matched control subjects.
Short-term endocrine and immune measures will include: serum levels of various cytokines; serum cortisol, C-reactive protien, Vascular endothelial growth factor, leukocyte subpopulations and their functional markers; and Natural killar cells activity. All indices will be assessed repeatedly within subjects, using freshly drawn blood samples that will be collected twice before surgery (days -5 and on the morning of surgery), and on post-operative days 1 and 3. Resected malignant tumors and normal colonic tissue will be tested for catecolamines (CA) and prostaglandines (PG) receptor expression. Clinical outcomes will include perioperative complic Tumor recurrence by abdominal CT scan and colonoscope[recurrence survey starts 6 months after surgery and then every 6 months for 2 years] Khaled Madbouly All 18 Years: 70 Years 200 Khaled Madbouly Interventional Study Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel; 15/08/2012 14/08/2012 13/01/2020 https://anzctr.org.au/ACTRN12612000852853.aspx Localised/Locoregional Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Etodolac; Propranolol Recurrence rate; Biomarker Phase 2 DB01628; DB00165 N
ACTRN12614000507684 Pre-surgical aromatase inhibitor combined with non-steroidal anti inflammatory drug treatment in breast cancer Recruiting post menopausal breast cancer;
post menopausal breast cancer;Cancer - Breast in window of time between diagnosis and surgery, post-menopausal women with ER positive breast cancer will be treated with an aromatase inhibitor alone, letrozole 2.5mg daily oral tablet, or with aspirin 200mg twice daily, oral tablet, in an anti inflammatory dose. Adherence will be monitored by twice weekly nurse review, and blood estradiol levels. change in biological markers, including inflammation and proliferation, over 14 days of treatment. Pre- and post treatment tumour samples will be compared, and studied by immunohistochemistry for immune cell subsets, inflammatory cells, and tumour cell Ki67. Gene expression profiling using the same tumour samples will also be studied at a later stage.[14 days, or day of surgery if this is sooner.] University of otago Female 50 Years: No limit 100 Health Research Council of New Zealand Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; 04/12/2014 13/05/2014 13/01/2020 https://anzctr.org.au/ACTRN12614000507684.aspx Localised/Locoregional Hospital/University/Research Institute Y N N New Zealand Breast Breast Cancer - ER/HR+ Acetylsalicylic Acid Biomarker Phase 2 DB01048 N
ACTRN12612000416897 Sequential evaluation of tumours undergoing pre-operative therapy with aromatase inhibitors and metformin (setup-aim) a neo-adjuvant pilot study in operable hormone sensitive breast cancer in post menopausal women Recruiting hormone positive operable breast cancer;
hormone positive operable breast cancer;Cancer - Breast 2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) plus aromatase inhibitor (oral tablets 1 mg Arimidex (trade name) or oral tablets 2.5 mg Femara (trade name)) all prior to surgery Reduction in tumour tissue Ki67 level (proliferative index)[At surgery to be performed 4 weeks after comencing treatment] Dr Vinod Ganju Female 18 Years: No limit 40 Victorian Breast Cancer Research Consortium Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy; 30/07/2014 13/04/2012 13/01/2020 https://anzctr.org.au/ACTRN12612000416897.aspx Localised/Locoregional Collaborative Group Y N N Australia Breast Breast Cancer - ER/HR+ Metformin Biomarker Other DB00703 N
ACTRN12613000520730 The effect of adjuvant therapy with aspirin on relapse prevention of hepatocellular carcinoma after curative resection: A prospective randomized controlled trial Not yet recruiting recurrence of hepatocellular carcinoma with microvascular tumor thrombus after curative resection;
recurrence of hepatocellular carcinoma with microvascular tumor thrombus after curative resection;Cancer - Liver After 1 month of the curative resection, the adjuvant group received 100mg aspirin tablet one time per one day by oral until tumor recurrence confirmed by Liver contrast-enhanced CT or MRI tumor with or without elevated AFP or 2 years after operation or the patient death during the study.
The monthly review after the blood, liver, kidney function, alpha-fetoprotein (AFP) and liver ultrasound. The three-monthly review of liver-enhanced CT or MRI. If bone pain, line ECT or check
The processing schedule of Adverse reactions:
a. Grade III adverse reactions: aspirin dose reduced by 50 ;
b. Grade III adverse reactions are continued more than 2 weeks or Grade IV adverse reactions: stop taking aspirin
c. When WBC <2.5 109 / L and/or PLT <40 109 / L: aspirin dose reduced by 50 and get drugs which can enhance white blood cells and/or platelet count;
d. When the dose of aspirin reduced but WBC and/or platelet count continued to decline: stop taking aspirin
A standardized clinical data management procedure will be carried out to make sure all of the data including the data on the adherences satisfy good clinical practice (GCP) requirements. All of the data will be entered in a verified database while the original paper records will be kept for at least 5 years. To make sure that the data in the database is consistent with the original one, a data validation process will be carried out. Disagreements were adjudicated by answering the query forms after referring to the original records. Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scan or selective hepatic arteriography in subjects with an elevated AFP level or with a newly identified mass[Time from curative resection to the first diagnosis of tumor recurrence];Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census[Every year after operation for 2 years] Estern hepatobiliary surgery hospital All 18 Years: 70 Years 120 Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; 01/06/2013 10/05/2013 13/01/2020 https://anzctr.org.au/ACTRN12613000520730.aspx Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Acetylsalicylic Acid DFS/RFS/EFS Not available/Missing DB01048 N
ACTRN12614000133639 The STRICT pilot study - Simvastatin Therapy for Reducing Inflammation in Colorectal cancer Trial Not yet recruiting Colorectal cancer;Systemic Inflammation;
Colorectal cancer
Systemic Inflammation;Cancer - Bowel - Back passage (rectum) or large bowel (colon);Inflammatory and Immune System - Other inflammatory or immune system disorders Participants will receive standard first line chemotherapy, as chosen by their treating medical oncologist. In addition, participants will be asked to take a daily 40mg dose of simvastatin orally in the evening from the first day of chemotherapy until tumour progression or patient is withdrawn from treatment due to clinician or patient decision.
Adherence to medication will be conducted using patient diaries, completion of a monthly Medication Adherence Record Scale-5 questionnaire, and pharmacy records. Toxicity: Incidence of serious Grade 3 or 4 toxicity graded according to NCI CTCAE version 4.03[until tumour progression (anticipated to be <12 months)] University of Sydney All 18 Years: No limit 10 Northern Translational Cancer Research Unit SeedFunding;Bosch Institute (University of Sydney) Translational Grant in Aid Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy; 01/04/2014 05/02/2014 13/01/2020 https://anzctr.org.au/ACTRN12614000133639.aspx Advanced/Metastatic Hospital/University/Research Institute N N N Australia GI Colon Cancer; Rectal Cancer Simvastatin Safety and/or Dose Phase 2 DB00877 N
ACTRN12610000936022 Vitamin D supplementation prior to surgery for colorectal cancer: a randomised pilot study. Not yet recruiting Colorectal Cancer;
Colorectal Cancer;Cancer - Bowel - Back passage (rectum) or large bowel (colon) Colorectal cancer patients scheduled to undergo routine elective surgery at Dunedin Hospital will be randomised to receive either a single oral 5mg dose of vitamin D3 (cholecalciferol), or identical placebo to be taken 7-21 days prior to surgery.
A dose of 5mg of vitamin D3 will consistently achieve therapeutic serum levels >80nmol/L, peaking at 1 week and gradually falling thereafter. The dose is safe and designed to rapidly achieve desirable levels without delaying surgery.
All patients enrolled will recieve all other treatment and care as they would have otherwise done so. A significant increase in the expression of genes containing the Vitamin D responsive element (VDRE), in tumour tissue, in patients receiving active study medication compared to placebo.
Previously published data on the effects of vitamin D on gene expression in a colorectal cancer cell line will be used to identify genes that are responsive to vitamin D. Affymetrix microarray data from these experiments are available from the NCBI GEO database under the accession number GSE444. In addition, genes representing vitamin D targets in normal colon tissues will be identified by searching publically available colon array databases for expressed genes which contain the VDRE. The VDRE element is present within the promoter region of genes activated by vitamin D and therefore acts as a convenient tag to identify vitamin D responsive genes.
RNA will be isolated from CRC samples from 50 patients, half of whom will have received vitamin D. RNA expression profiles of the 50 tumour RNA samples will then be generated in the Otago Genomics Facility using Affymetrix HG-U133+2.0 GeneChips. Evidence of activation of vitamin D pathways in the tumours from treated and untreated patients will be determined using the vitamin D responsive genes identified above. This will be accomplished by generating a vitamin D meta-gene to represent the coordinated expression of these genes across all tumours, so that tumours exhibiting a molecular response to vitamin D will have high levels of the meta-gene. This meta-gene will then be tested for association with treatment status, as well as clinicopathological (e.g. tumour stage, histology etc), molecular (e.g. proliferation) and immune reponse variables.[Tissue samples will be collected on the day of surgery. These will be batched and analysed in the laboratory within 6 months of the final patients surgery.];A significant difference between treatment groups with respect to macrophage activation against tumour tissue and their ability to prime T cells.
Macrophages isolated from the blood and tumour tissue of CRC patients will be infected with bacterial pathogens in vitro and their ability to destroy these agents measured by quantifying nitric oxide production using the Greiss reaction. Their ability to prime the adaptive immune response will also be measured by analysing activation of T cells recovered from patient tissues using flow cytometry of surface activation markers. Results will be compared between treatment and placebo groups.[Tissue samples will be collected on the day of surgery. These will be batched and analysed in the laboratory within 6 months of the final patients surgery.] University of Otago All 18 Years: No limit 50 University of Otago Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Bio-availability; 01/03/2011 03/11/2010 13/01/2020 https://anzctr.org.au/ACTRN12610000936022.aspx Localised/Locoregional Hospital/University/Research Institute Y N N New Zealand GI Colon Cancer; Rectal Cancer Calcipotriol; Calcitriol Other (specify) Phase 2 DB00136; DB08907 N
ACTRN12612001050842 Valproic acid and Metformin to treat patients with brain tumours Not yet recruiting Brain tumours - Glioblastoma multiforme (GBM);
Brain tumours - Glioblastoma multiforme (GBM);Cancer - Brain Valproic acid and metformin added to standard therapy (Temozolomide/radiotherapy)
Valproic acid: oral - 200 mg twice daily to a maximum of 60 mg/day; dose adjusted based on plasma levels; maximum of 10 months
Metformin: oral titrated upto 2 gm per day; maximum of 10 months To assess the tolerability and feasibility of adding sodium valproate and metformin to concurrent TMZ+XRT in patients with newly diagnosed GBM.
This outcome will be assessed by clinical examination, blood tests and adverse event monitoring[7 weeks from study entry] Flinders Centre for Innovation in Cancer, Flinders University/Flinders Medical centre All 18 Years: No limit 12 Flinders Centre for Innovation in Cancer, Flinders University/Flinders Medical centre Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety; 01/01/2013 03/10/2012 13/01/2020 https://anzctr.org.au/ACTRN12612001050842.aspx Localised/Locoregional Hospital/University/Research Institute N N N Australia CNS Glioblastoma Metformin; Valproic Acid Safety and/or Dose Phase 1 DB00703; DB00177 N
ACTRN12614001054606 Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy Recruiting Metastatic prostate cancer ;
Metastatic prostate cancer ;Cancer - Prostate This is a two-arm study. Both Arm 1 and Arm 2 will be receiving androgen deprivation therapy (ADT). The ADT used is a combined androgen blockade with luteinizing hormone releasing hormone (LHRH) agonist (45mg EligardTrademark) and AR antagonist (50mg Cosudex/bicalutamide) for the first 4 weeks as per standard of care. After that, EligardTrademark will continue as monotherapy 6 monthly unless clinically indicated for complete androgen blockade. At 12 weeks into ADT, participants will receive 1500mg metformin (3x500mg daily, with meals) or placebo depending on the treatment arm allocated after randomization.
Metformin or Placebo tablets will be dispensed every 12 weeks. Participants will need to return the unused tablets to the research team before or after each dispensing for drug accountability purpose. Moreover, participants will have 6 weekly medical review.
Arm 1
Metformin hydrochloride 500mg tablet
Dosage: 1500mg daily
Duration: 30 weeks
Mode of administration: Oral
Time to progression of disease defined as biochemical, radiographic or clinical progression[Prostate specific antigen and 6 weekly clincial review will be used to determine biochemical and clinical progression: every 6 weeks for 42 weeks and at week 54 (end-of-study visit)
CT scan and bone scan will be used to determine radiographic progression: if clinically indicated. Radiographically, Prostate Cancer Working Group (PCWG) 2 criteria will be used. ] Queensland University of Technology Male 18 Years: No limit 80 2014 Princess Alexandra Hospital Research Support Scheme Grants;Tolmar Australia Pty Ltd Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; 08/09/2014 02/10/2014 13/01/2020 https://anzctr.org.au/ACTRN12614001054606.aspx Advanced/Metastatic Hospital/University/Research Institute Y N N Australia Urological Prostate Cancer Metformin Other (specify) Phase 2 DB00703 N
ACTRN12616001021460 Sodium Valproate/Metformin Combination therapy for prostate cancer Not yet recruiting Prostate cancer;
Prostate cancer;Cancer - Prostate Combination of sodium valproate and metformin will be administered as oral tablets.
Three dose levels of the drugs are planned. First level € a fixed dose of Met and VPA at 500 mg twice daily will be given to the participants. If no dose limiting toxicity is seen in this cohort I (N=3), after the 4 weeks of drug administration, participants will be next dosed at level 2 dosing where the starting dose is 500 mg twice daily for both drugs. In this cohort II (N=3), Met dose alone will be increased to 1000 mg twice daily from week 2 onwards while VPA dose will be maintained at 500 mg twice daily. If no dose limiting toxicity is seen in this cohort II, subjects will be dosed at next dose level. Subjects in this cohort III (N=6) will have both the drug doses increased from the starting dose of 500 mg twice daily to 1000 mg twice daily sequentially. Dose escalation will not proceed beyond the 1000 mg twice daily schedule. Participants in cohort I will receive 4 weeks on Met and VPA 500mg each twice daily; cohort II week 1 Met and VPA 500mg each twice daily then Met 1000mg and VPA 500mg twice daily from week 2 -4; cohort III week 1 Met and VPA 500mg each twice daily then Met 1000mg and VPA 500mg twice daily from week 2; then Met 1000 mg and VPA 1000 mg twice daily week 3-4. All study drugs will be ceased at least 48 hours but no more than 7 days prior to surgery. Participants will be requested to return any left over tablets. To evaluate the safety of the combination of Metformin and VPA in men undergoing radical prostatectomy for prostate cancer.
Safety will be assessed using the common toxicity critieria (NCI-CTC v1.0) as well as physical examination and blood tests for organ function.[At the end of 4 weeks of commencement of study drug therapy] Flinders University Male 18 Years: No limit 12 The Repat Foundation: Road Home Grant Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Type of endpoint: Safety; 01/12/2016 02/08/2016 13/01/2020 https://anzctr.org.au/ACTRN12616001021460.aspx Localised/Locoregional Hospital/University/Research Institute N N N Australia Urological Prostate Cancer Metformin; Valproic Acid Safety and/or Dose; Biomarker Phase 1 DB00703; DB00177 N
ChiCTR2000038968 A prospective, randomized controlled, multicenter clinical trial of indomethacin in the treatment of abiraterone-resistant castration-resistant prostate cancer Recruiting Prostate Cancer experiment group:indomethacin treatment;control group:Abiraterone treatment; OS;PFS;PSA response rate; The Second Hospital of Tianjin Medical University Male - experiment group:60;control group:60; Special funds for clinical research projects of the Second Hospital of Tianjin Medical University Interventional Study Parallel 30/10/2020 10/11/2020 01/11/2021 http://www.chictr.org.cn/showproj.aspx?proj=61151 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Urological Prostate Cancer Indomethacin Response rate; PFS; OS Phase 4 Not found in DrugBank N
ChiCTR2000039296 Effects of intra-venous lidocaine in general anesthesia on postoperative inflammatory response and prognosis in patients with breast cancer Recruiting Breast Cancer Lidocaine Group:Total intravenous anesthesia was used. Lidocaine was used in the induction and maintenance of anesthesia;Opioids Group:Total intravenous anesthesia was used. Opioids was used in the induction and maintenance of anesthesia; NLR;LMR;IL-6;IL-8;OFS;OS; Tongji Hospital Affiliated to Tongji University Female - Lidocaine Group:120;Opioids Group:120; National Natural Science Foundation of China (No. 81974155) Interventional Study Parallel 01/01/2021 22/10/2020 25/01/2021 http://www.chictr.org.cn/showproj.aspx?proj=63173 Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Lidocaine PFS; OS; Biomarker Not available/Missing DB08882 N
ChiCTR2000039651 Effects of sevoflurane inhalation anesthesia on proliferation and apoptosis of colon cancer cells in vitro: a randomized controlled trial. Recruiting Colorectal cancer Sevo:Sevoflurane inhalation anesthesia was performed during the operation;Pro:propofol intravenous anesthesia was performed during the operation;Sevo+Pro:sevoflurane € propofol combined anesthesia during the operation; Postoperative mortality; Affiliated Hospital of Zunyi Medical University All - Sevo:10;Pro:10;Sevo+Pro:10; Doctoral project Interventional Study Parallel 11/01/2020 11/04/2020 02/08/2021 http://www.chictr.org.cn/showproj.aspx?proj=63427 Localised/Locoregional Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Propofol OS; Biomarker Not available/Missing DB00571 N
ChiCTR2000041072 A Phase II Open-Label Randomized Controlled Clinical Trial of Pembrolizumab Plus Chemotherapy Combined With Cox-2 Inhibitor (Celecoxib) Versus Pembrolizumab Plus Chemotherapy In Advanced Non-small Cell Lung Cancer (NSCLC) Recruiting Lung Cancer Trial group:Pembrolizumab + chemotherapy (squamous cell carcinoma: albumin paclitaxel + carboplatin / adenocarcinoma: pemetrexed + carboplatin) + celecoxib;Control group:Pembrolizumab + chemotherapy (squamous cell carcinoma: albumin paclitaxel + carboplatin / adenocarcinoma: pemetrexed + carboplatin); ORR;PFS;Side-effect; West China Hospital, Sichuan University All - Trial group:81;Control group:81; West China Hospital, Sichuan University Interventional Study Parallel 01/01/2021 17/12/2020 03/01/2021 http://www.chictr.org.cn/showproj.aspx?proj=66052 Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Celecoxib Safety and/or Dose; Response rate; PFS Phase 2 DB00567 N
ChiCTR2000040604 the effect of anaesthetic technique in patients undergoing NSCLC surgery- a multicenter study Pending non small cell lung cancer A:the sedative of induction and anesthesia maintenance is sevofluane;B:the sedative of induction and anesthesia maintenance is propofol;C:no;D:Paravertebral block pre-operation; NRF2;NLRP3;ROS;GSH;IL-11; National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College All - A:30;B:30;C:30;D:30; Sanming Project of Medical and Health in Shenzhen Interventional Study Parallel 12/07/2020 12/03/2020 15/03/2021 http://www.chictr.org.cn/showproj.aspx?proj=65257 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Propofol Biomarker Phase 4 DB00571 N
NCT00565708 Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers ASCOLT Active, not recruiting Colorectal Cancer Other: placebo; Drug: Acetylsalicylic acid Disease-free survival; Overall survival National Cancer Centre, Singapore; University of Oxford; Australasian Gastro-Intestinal Trials Group; INDOX Cancer Research Network All 18 Years and older (Adult, Older Adult) 1587 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment CDR0000577892; SINGAPORE-ICR-02; SINGAPORE-ASCOLT 12/01/2008 12/01/2025 06/01/2026 30/11/2007 13/09/2021 https://ClinicalTrials.gov/show/NCT00565708 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Singapore GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 3 DB01048 N
NCT03999723 Combining Active and Passive DNA Hypomethylation EVI-3 Recruiting Myelodysplastic Syndromes|Acute Myeloid Leukemia|Chronic Myelomonocytic Leukemia Dietary Supplement: Vitamin C; Dietary Supplement: Placebo Event-free survival; Adverse events and serious adverse events; Overall survival; Overall response rate; Patient-reported outcome (PRO) measures; Variant allele frequency (VAF) of mutated clones; Global 5-hydroxymethylcytosine (5-hmC)/5-methylcytosine (5-mC); Site specific 5-hmC/5-mC; Gene expression; mRNA expression of HERV and HERV specific T-cell responses; Duration of azacitidine (AZA) therapy Kirsten Gr nb k; Van Andel Research Institute; Karolinska University Hospital; Skane University Hospital; Sahlgrenska University Hospital, Sweden; Oslo University Hospital; Helsinki University Central Hospital; University of Southern California; Imperial College London; University of Copenhagen; Zealand University Hospital; Aalborg University Hospital; Odense University Hospital; Technical University of Denmark; Aarhus University Hospital; Norrland University Hospital; Uppsala University Hospital; Rigshospitalet, Denmark All 18 Years and older (Adult, Older Adult) 196 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment H-18040929 09/11/2019 03/01/2024 03/01/2024 27/06/2019 29/09/2021 https://ClinicalTrials.gov/show/NCT03999723 Any/All Stages Hospital/University/Research Institute Y N N Denmark Leukemia Acute Myeloid Leukemia, Adult Ascorbic acid DFS/RFS/EFS Phase 2 DB00335 N
NCT03596073 Topical Calcipotriene Treatment for Breast Cancer Immunoprevention Recruiting Breast Cancer Drug: Topical Calcipotriene Ointment; Other: Topical Vaseline The changes in the magnitude of CD3+ T cell infiltration in tumor microenvironment; The comprehensive changes in tumor immune microenvironment; The changes in tumor immune microenvironment in patients with neoplastic tumors versus benign lesions; The changes in tumor immune microenvironment in patients with stage I-II, versus stage 0 tumors; The changes in tumor immune microenvironment in patients with hormone receptor and Her2 positive versus triple negative tumors; Serum Serum Thymic Stromal Lymphopoietin (TSLP) levels (picogram/milliliter) before and after topical calcipotriene treatment compared to Vaseline control group; Disease free survival; Number of Participants with Treatment Related Adverse Events Massachusetts General Hospital All 50 Years and older (Adult, Older Adult) 120 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 18-040 11/07/2018 31/12/2022 31/07/2025 23/07/2018 11/04/2021 https://ClinicalTrials.gov/show/NCT03596073 Localised/Locoregional Hospital/University/Research Institute N N N United States Breast Any Breast Cancer Calcipotriol Biomarker Phase 1 DB00136 N
NCT03363659 Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme Active, not recruiting Glioblastoma|Glioblastoma Multiforme Drug: Disulfiram; Dietary Supplement: Copper gluconate; Drug: Temozolomide Progression Free Survival (PFS); Overall Survival; Quality of life (QOL) Aurora Health Care All 18 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 17.56 28/03/2018 31/12/2021 31/12/2022 12/06/2017 09/09/2021 https://ClinicalTrials.gov/show/NCT03363659 Any/All Stages Hospital/University/Research Institute N N N United States CNS Glioblastoma Disulfiram PFS Phase 2 DB00843 N
NCT02265770 An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma SIOP-EP-II Recruiting Childhood Ependymoma Drug: 16 weeks of VEC + CDDP; Drug: VEC + HD-MTX; Drug: Chemotherapy + Valproate; Radiation: Conformal radiotherapy; Drug: VEC; Drug: Chemotherapy; Radiation: conformal radiotherapy +/- boost Gross Total Resection rate; Progression-Free Survival; Number of treatment responders; Number of participants undergoing a second-look surgery; Overall Survival; Quality of Survival; Evaluation of neuropsychological morbidity; Comparison of neuroendocrine morbidity; Number of participants with adverse events as a measure of safety and tolerability; Radiotherapy-free survival rate Centre Leon Berard All up to 22 Years (Child, Adult) 480 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SIOP Ependymoma II (ET-13-002); 2013-002766-39; VHP358 06/02/2015 06/01/2028 08/01/2031 16/10/2014 13/10/2021 https://ClinicalTrials.gov/show/NCT02265770 Localised/Locoregional Hospital/University/Research Institute N N Y France CNS Ependymoma Valproic Acid Safety and/or Dose; Response rate; PFS; OS; QoL; Other (specify) Phase 2/3 DB00177 N
2021-001375-16 DIPGEN ndash; Multicenter, open label study using molecularly determined targeted therapies in children 3-18 years of age with DIPG (diffuse intrinsic pontine glioma- DIPG) DIPGen Ongoing diffuse intrinsic pontine glioma 1. Overall survival (OS) from the time of diagnosis until last visit or death. 2. Safety assessment of sirolimus administered during radiotherapy and in combination with trametinib as adjunctive treatment after irradiation. The Children's Memorial Health Institute All Under 18; Elderly 65+ 100 Medical Research Agency - Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001375-16/PL Localised/Locoregional Hospital/University/Research Institute N N N Poland CNS DIPG/DMG Sirolimus OS Phase 2 DB01261 N
NCT04617067 Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer Active, not recruiting Advanced Pancreatic Cancer Drug: Paricalcitol; Drug: Gemcitabine (GEM) and Nab-paclitaxel Progression free survival; Overall survival (OS); Time to treatment failure; Tumour response rate Duration of response Cancer Trials Ireland All 18 Years and older (Adult, Older Adult) 15 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CTRIAL-IE 19-33; 2020-000073-24 16/10/2020 04/01/2024 04/01/2024 11/05/2020 18/11/2021 https://ClinicalTrials.gov/show/NCT04617067 Advanced/Metastatic Collaborative Group N N N Ireland GI Pancreatic Cancer Paricalcitol Response rate; PFS; OS; Other (specify) Phase 2 DB00715 N
NCT04348747 Dendritic Cell Vaccines Against Her2/Her3, Cytokine Modulation Regimen, and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer Not yet recruiting Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Malignant Neoplasm in the Brain|Metastatic Triple-Negative Breast Carcinoma|Prognostic Stage IV Breast Cancer AJCC v8 Biological: Anti-HER2/HER3 Dendritic Cell Vaccine; Drug: Celecoxib; Biological: Pembrolizumab; Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod Central nervous system (CNS) objective response rate (ORR); Volumetric quantification of brain metastases; Non-CNS (i.e. of systemic disease) response rate; Median CNS progression free survival (PFS); Non-CNS PFS; Overall PFS; Proportion of patients who have a CNS PFS; Median overall survival (OS); Incidence of adverse events; Proportion of patients not requiring retreatment for their brain metastasis at 6 months since the first dose of anti-HER2/3 vaccine; Rate of failure of irradiated lesions Roswell Park Cancer Institute; National Cancer Institute (NCI) Female 18 Years and older (Adult, Older Adult) 23 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I-19-04120; NCI-2020-01520; P30CA016056 02/01/2022 02/01/2024 02/01/2025 16/04/2020 01/05/2022 https://ClinicalTrials.gov/show/NCT04348747 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - HER2+; Breast Cancer - TNBC Celecoxib Response rate Phase 2 DB00567 N
NCT05164952 Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole Recruiting Use of Zoledronic Acid in Breast Cancer Drug: Zoledronic Acid 4 MG The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.; percentage change in total hip BMD at each assessment, fracture incidence in percentage, time to disease recurrence in months (local relapse or distant metastasis), DFS in months, and safety.; Fracture incidence in percentage Assiut University Female 45 Years to 80 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Zoledronic Acid In Breast Ca 30/09/2021 30/08/2023 30/09/2023 21/12/2021 21/12/2021 https://ClinicalTrials.gov/show/NCT05164952 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Breast Cancer - ER/HR+ Zoledronic Acid Recurrence rate; Biomarker Phase 3 N
NCT02796261 Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients STELLAR Active, not recruiting Anaplastic Astrocytoma|Recurrent Anaplastic Astrocytoma Drug: Eflornithine; Drug: Lomustine Overall survival; Progression-free survival (PFS); Objective response rate (ORR) Orbus Therapeutics, Inc. All 18 Years and older (Adult, Older Adult) 343 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OT-15-001 07/01/2016 06/01/2023 06/01/2023 06/10/2016 21/01/2022 https://ClinicalTrials.gov/show/NCT02796261 Palliative Recurrent/Refractory Company Y N N United States CNS Astrocytoma Eflornithine OS Phase 3 DB06210 N
NCT02647099 Adjuvant Low Dose Aspirin in Colorectal Cancer ALASCCA Recruiting Colorectal Cancer Drug: Acetylsalicylic acid; Drug: Placebo Time To Recurrence (TTR); Disease free survival (DFS); Overall survival (OS); Frequency and severity of adverse events (AE) Anna Martling; Uppsala University Hospital; Skane University Hospital; Karolinska Institutet All 18 Years to 80 Years (Adult, Older Adult) 600 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 921-2014-7074 04/07/2016 08/01/2024 08/01/2026 01/06/2016 14/04/2022 https://ClinicalTrials.gov/show/NCT02647099 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Sweden GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS; Recurrence rate Phase 3 DB01048 N
NCT03326791 Aspirin in Colorectal Cancer Liver Metastases ASAC Recruiting Colorectal Cancer Liver Metastases|Colorectal Cancer|Liver Metastases Drug: Acetylsalicylic acid; Drug: Placebo Oral Tablet Disease Free Survival (DFS) after three years treatment; Time to recurrence (TTR) of disease after randomization; Overall survival (OS) three years after treatment start; Health-related Quality of Life with 36-item Short Form Health Survey (SF-36); Health-related Quality of Life with EuroQoL 5 Dimensions (EQ-5D); ASA in CRC and Cost-Effectiveness Analyses I; ASA in CRC and Cost-Effectiveness Analyses II; ASA in CRC and Cost-Effectiveness Analyses III Oslo University Hospital; Norwegian Cancer Society; The Research Council of Norway; Klinbeforsk All 18 Years and older (Adult, Older Adult) 800 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention 2014/2217 15/12/2017 02/01/2022 02/01/2026 31/10/2017 22/04/2022 https://ClinicalTrials.gov/show/NCT03326791 Advanced/Metastatic Hospital/University/Research Institute Y N N Norway GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS; Recurrence rate Phase 2/3 DB01048 N
NCT04697576 Intralesional Influenza Vaccine for the Treatment of Stage I, II, and IV Melanoma Recruiting Clinical Stage I Cutaneous Melanoma AJCC v8|Clinical Stage IA Cutaneous Melanoma AJCC v8|Clinical Stage IB Cutaneous Melanoma AJCC v8|Clinical Stage II Cutaneous Melanoma AJCC v8|Clinical Stage IIA Cutaneous Melanoma AJCC v8|Clinical Stage IIB Cutaneous Melanoma AJCC v8|Clinical Stage IIC Cutaneous Melanoma AJCC v8|Clinical Stage IV Cutaneous Melanoma AJCC v8|Metastatic Melanoma Biological: Ipilimumab; Biological: Nivolumab; Biological: Pembrolizumab; Biological: Quadrivalent Inactivated Influenza Vaccine; Procedure: Resection Incidence of adverse events (AEs); Maximum tolerated dose (MTD) in Cohorts #1 and #2; Tumor dimensions of injected (Cohorts #1); Tumor dimensions of non-injected lesions (Cohort #2); Time to disease progression (local or distant); Biomarker analysis; Granzyme B H-score; NanoString Pan Cancer Immune Profiling Panel; Tumor-infiltrating lymphocytes analysis; Degree of tumor regression (percent); Changes in micro ribonucleic acid (RNA) expression; T-cell subset evaluation and changes in circulating microRNA Carlo Contreras; Ohio State University Comprehensive Cancer Center All 18 Years to 90 Years (Adult, Older Adult) 36 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OSU-20221; NCI-2020-13282 20/10/2021 31/12/2023 31/12/2024 01/06/2021 29/04/2022 https://ClinicalTrials.gov/show/NCT04697576 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N Y N United States Skin Melanoma Influenza vaccine Safety and/or Dose; Biomarker; Other (specify) Phase 1 DB01029 N
NCT05116917 Immunotherapy Combined With Radiation and Influenza Vaccine for Pancreatic Cancer. INFLUENCE Recruiting Pancreatic Cancer Drug: Nivolumab; Drug: Ipilimumab; Biological: Influenza vaccine; Radiation: SBRT Objective response rate (ORR); Duration of response (DoR); Disease control rate (DCR); Progression free survival (PFS); Overall survival (OS); EORTC QLQ-C30; Treatment-related adverse events as assessed by CTCAE v5.0 Herlev Hospital All 18 Years and older (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GI 2118 11/05/2021 12/01/2023 12/01/2024 11/11/2021 16/03/2022 https://ClinicalTrials.gov/show/NCT05116917 Advanced/Metastatic Hospital/University/Research Institute N N N Denmark GI Pancreatic Cancer Influenza vaccine Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 2 DB01029 N
NCT03753334 Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer. RCT-EPAII-BCR Recruiting Prostate Cancer Combination Product: MAG-EPA; Dietary Supplement: Placebo group Prostate-specific antigen (PSA) doubling time from baseline to 12 months.; Fatty acid profiles in red blood cells, changes relative to baseline (time 0). CHU de Quebec-Universite Laval Male 18 Years to 100 Years (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2017-3407 07/10/2017 06/01/2023 12/01/2023 27/11/2018 31/03/2022 https://ClinicalTrials.gov/show/NCT03753334 Recurrent/Refractory Hospital/University/Research Institute Y N N Canada Urological Prostate Cancer Omega 3 Biomarker Phase 2 DB00338 N
NCT05300958 Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer Recruiting Triple Negative Breast Cancer Drug: Deferoxamine Plus Chemotherapy Objective Response Rate (ORR); clinical benefit rate (CBR); progression-free survival (PFS); overal survival (OS) Sun Yat-sen University Female 18 Years to 70 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SYSUCC-017 21/03/2022 30/09/2023 10/01/2024 29/03/2022 29/03/2022 https://ClinicalTrials.gov/show/NCT05300958 Advanced/Metastatic Hospital/University/Research Institute N N N China Breast Breast Cancer - TNBC Deferoxamine Response rate; PFS; OS Phase 2 DB04932 N
NCT02905578 A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1) Recruiting Pancreatic Neoplasms|Cancer of Pancreas|Cancer of the Pancreas|Neoplasms, Pancreatic|Pancreas Cancer|Pancreas Neoplasms|Adenocarcinoma Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: Pharmacological ascorbate Overall survival; Tumor Response; Progression free survival; Adverse event frequency and categorization Joseph J. Cullen; National Institutes of Health (NIH); National Cancer Institute (NCI); Holden Comprehensive Cancer Center; McGuff Pharmaceuticals, Inc.; University of Iowa All 18 Years and older (Adult, Older Adult) 65 Other; NIH; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 201801759; 3P30CA086862; 5U01CA140206; P01CA217797 28/11/2018 31/12/2025 31/12/2025 19/09/2016 07/08/2022 https://ClinicalTrials.gov/show/NCT02905578 Advanced/Metastatic Hospital/University/Research Institute Y N N United States GI Pancreatic Cancer Ascorbic acid OS Phase 2 DB00335 N
NCT02344355 A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme Active, not recruiting Glioblastoma Multiforme Drug: Temozolomide; Radiation: radiation therapy; Drug: Ascorbic Acid Overall Survival (OS); Progression Free Survival (PFS); Adverse Event Frequency Bryan Allen; Holden Comprehensive Cancer Center; National Cancer Institute (NCI); University of Iowa All 18 Years and older (Adult, Older Adult) 90 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201504786 13/03/2017 07/06/2022 12/01/2024 22/01/2015 07/11/2022 https://ClinicalTrials.gov/show/NCT02344355 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma Ascorbic acid OS Phase 2 DB00335 N
NCT02786875 Diet, Exercise and Vitamin D in Breast Cancer Recurrence DEDiCa Active, not recruiting Breast Cancer Other: low Glycemic Index Mediterranean diet; Other: Mediterranean diet; Behavioral: Moderate physical activity; Behavioral: Basic physical activity; Drug: high level Vitamin D; Drug: normal level Vitamin D Recurrence of disease at study end; Changes in glycemic markers; Changes in hormonal markers; Changes in cardiovascular risk factors; Changes in epigenetic factors National Cancer Institute, Naples; Unity Health Toronto; University of Catania Female 30 Years to 74 Years (Adult, Older Adult) 506 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment DEDiCa; 2015-005147-14 11/04/2016 10/10/2020 15/12/2023 06/01/2016 23/05/2022 https://ClinicalTrials.gov/show/NCT02786875 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Any Breast Cancer Cholecalciferol DFS/RFS/EFS; Recurrence rate; Biomarker Phase 3 Not found in DrugBank N
NCT02671890 Disulfiram and Chemotherapy in Treating Patients With Refractory Solid Tumors or Metastatic Pancreatic Cancer Recruiting Metastatic Pancreatic Adenocarcinoma|Refractory Malignant Solid Neoplasm|Stage IV Pancreatic Cancer AJCC v8 Drug: Chemotherapy; Drug: Disulfiram; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis Maximum tolerated dose (MTD) (Cohort I); Adverse events profile (Cohort I and II); Toxicity profile defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment (Cohorts I and II); Overall survival (OS) (Cohort I and II); Change in muscle area at the L3 level using a computed tomography (CT) scan (Cohort II); Response rate (Cohort II); Change in muscle area at the L3 level using a computed tomography scan (Cohort II); Changes in fist-grip strength as measured by hand dynamometer (Cohort II) Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 74 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MC1512; NCI-2016-00007; 15-003194; P30CA015083 25/02/2016 05/05/2023 05/05/2023 02/02/2016 06/02/2022 https://ClinicalTrials.gov/show/NCT02671890 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N United States Multiple cancer types; GI Any solid tumours; Pancreatic Cancer Disulfiram Safety and/or Dose Phase 1 DB00843 N
NCT02679144 Neuroblastoma Maintenance Therapy Trial NMTT Recruiting Neuroblastoma Drug: Difluoromethylornithine (DFMO) Number of participants with event free survival (EFS) during study.; Length of time that participants experience Overall Survival (OS); Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Peak Plasma Concentration (Cmax); Area under the plasma concentration versus time curve (AUC); Time to reach Peak Plasma Concentration (Tmax); Number of participants with ODC (Ornithine decarboxylase) single nucleotide polymorphisms. Wake Forest University Health Sciences; Beat NB Cancer Foundation; Team Parker for Life All 1 Year to 30 Years (Child, Adult) 258 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention NMTRC014 02/01/2016 02/01/2026 02/01/2029 02/10/2016 29/06/2022 https://ClinicalTrials.gov/show/NCT02679144 Localised/Locoregional Hospital/University/Research Institute N N Y United States Other Neuroblastoma Eflornithine DFS/RFS/EFS Phase 2 DB06210 N
NCT04564521 Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma. Recruiting Retinoblastoma Drug: Nitroglycerin; Drug: Normal saline The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent); The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent); The incidence of using vaso-active drugs (percent); The incidence of the side effect of nitroglycerin infusion (percent); The concentration of inhaled sevoflurane (vol ); The depth of anesthesia; Duration of anesthesia (min); Total procedure time (min); The procedural satisfaction score of radiologist (1-3); Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no) Seoul National University Hospital All up to 7 Years (Child) 36 Other Interventional Study Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment 2006-108-1134 28/09/2020 30/06/2024 30/12/2024 25/09/2020 06/03/2022 https://ClinicalTrials.gov/show/NCT04564521 Localised/Locoregional Hospital/University/Research Institute Y N Y Korea, Republic of Ocular Retinoblastoma Nitroglycerin Safety and/or Dose Other DB01422 N
NCT02333435 Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life RCT-EPA Active, not recruiting Prostate Cancer Dietary Supplement: EPA; Dietary Supplement: Placebo Change in Prostate Cancer Proliferative Index; Change in Inflammatory mediators levels- Systemic; Modulation of Inflammatory mediators levels - Prostatic; Modulation of the Quality of life of patients; Modulation of the psychosocial functioning of patients; Impact of inflammation on Quality of life; Impact of inflammation on psychosocial functioning CHU de Quebec-Universite Laval Male 18 Years and older (Adult, Older Adult) 130 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2012-1012 01/01/2015 12/01/2020 12/01/2023 01/07/2015 31/05/2022 https://ClinicalTrials.gov/show/NCT02333435 Localised/Locoregional Hospital/University/Research Institute Y N N Canada Urological Prostate Cancer Omega 3 QoL; Biomarker Phase 2 DB00338 N
NCT04729543 MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer MC2TCR Recruiting Melanoma|Melanoma, Uveal|Head and Neck Cancer Biological: Adoptive therapy with autologous MC2 TCR T cells Maximum Tolerated Dose (MTD) of MC2 TCR T cells; Objective anti-tumor responses of MC2 TCR T cells Erasmus Medical Center; Ludwig Institute for Cancer Research; Dutch Cancer Society; Stichting Coolsingel Rotterdam grant; Jan Ivo Stichting grant All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NL69011.000.19 20/10/2020 20/12/2022 20/10/2027 28/01/2021 06/02/2022 https://ClinicalTrials.gov/show/NCT04729543 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands Skin; Head and Neck Melanoma; Any head and neck squamous cell carcinoma Valproic Acid Safety and/or Dose; Biomarker Phase 1/2 DB00177 N
NCT03243461 International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013) HIT-HGG-2013 Recruiting Glioblastoma WHO Grade IV|Diffuse Midline Glioma Histone 3 K27M WHO Grade IV|Anaplastic Astrocytoma WHO Grade III|Diffuse Intrinsic Pontine Glioma|Gliomatosis Cerebri Drug: Temozolomide + Valproic Acid Comparison of effects of valproine acid with respect to historical control group. University of G ttingen; Deutsche Kinderkrebsstiftung; Hannover Medical School All 3 Years to 17 Years (Child) 167 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 01153; 2013-004187-56 17/07/2018 31/12/2023 31/12/2023 08/09/2017 06/06/2022 https://ClinicalTrials.gov/show/NCT03243461 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute N N Y Germany CNS Glioblastoma; DIPG/DMG; Astrocytoma; Other CNS Valproic Acid DFS/RFS/EFS Phase 3 DB00177 N
NCT05080790 Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma DiTuSarc Recruiting Leiomyosarcoma Drug: Dinutuximab Beta, Zoledronic acid, Interleukin-2 The primary objective of this study is to assess the feasibility of the combined treatment with dinutuximab beta, zoledronic acid and low-dose interleukin 2.; A secondary objective of this study is to assess the safety and tolerability of the combined treatment with dinutuximab beta, zoledronic acid and low-dose interleukin 2.; An additional secondary objective of this study is to assess the efficacy of the combined treatment with dinutuaseximab beta, zoledronic acid and low-dose interleukin 2. Institut f r Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest; EUSA Pharma, Inc. Female 18 Years and older (Adult, Older Adult) 10 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment DiTuSarc / GISG-20 15/11/2021 26/07/2024 26/07/2024 18/10/2021 06/03/2022 https://ClinicalTrials.gov/show/NCT05080790 Advanced/Metastatic Hospital/University/Research Institute N N N Germany Soft Tissue Sarcoma Leiomyosarcoma Zoledronic Acid Safety and/or Dose Phase 1 N
NCT00470223 Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma OS2006 Active, not recruiting Sarcoma Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: methotrexate; Drug: zoledronic acid; Procedure: conventional surgery Event-free survival; Overall survival; Percentage of good responders; Short term and long term toxicity UNICANCER; Novartis; Chugai Pharmaceutical; National Cancer Institute, France; SFCE; Ligue contre le cancer, France All 5 Years to 50 Years (Child, Adult) 318 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Sarcome 09/0603; UNICANCER-SARCOME-09-0603; 2006-003377-27 03/01/2007 12/01/2015 12/01/2025 05/07/2007 27/06/2022 https://ClinicalTrials.gov/show/NCT00470223 Neo-adjuvant/Window; Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N Y France Bone Sarcoma Osteosarcoma Zoledronic Acid Safety and/or Dose; Response rate; OS; DFS/RFS/EFS Phase 3 N
NCT04477200 Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma Recruiting Recurrent Glioblastoma|Recurrent Gliosarcoma|Recurrent Astrocytoma, Grade IV|Newly Diagnosed Glioblastoma|Newly Diagnosed Gliosarcoma|Newly Diagnosed Astrocytoma, Grade IV Drug: Mycophenolate Mofetil; Radiation: Radiation Therapy; Procedure: Re-resection (as part of standard of care); Drug: Temozolomide Concentration of mycophenolic acid (MPA) in tumor tissue in Phase 0 participants; Number of recurrent phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level; Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT1 period; Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT2 period; Concentrations of guanosine triphosphate (GTP) in tumor tissue in Phase 0 participants; Adverse events associated with treatment in all Phase 1 Participants; Adverse events associated with treatment in newly diagnosed phase 1 participants; Overall Response Rate in phase 1 participants with recurrent GBM/GS; Median Progression Free Survival (PFS) in phase 1 participants with recurrent GBM/GS; Median Freedom from Local Progression (FFLP) in phase 1 participants with recurrent GBM/GS; Median Overall Survival (OS) in phase 1 participants with recurrent GBM/GS University of Michigan Rogel Cancer Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 68 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UMCC 2019.192; HUM00175785; R37CA258346 08/05/2020 10/01/2024 10/01/2027 20/07/2020 07/11/2022 https://ClinicalTrials.gov/show/NCT04477200 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioblastoma; Astrocytoma; Other CNS Mycophenolate Safety and/or Dose; Biomarker Phase 1 DB08813 N
NCT01852890 Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I Active, not recruiting Pancreatic Neoplasms Drug: Ascorbate; Drug: Gemcitabine; Radiation: Radiation therapy Number of grade 3, 4, 5 adverse events during radiation; Time to progression; Overall survival; Number of grade 3, 4, 5 adverse events post-treatment Joseph J. Cullen; Holden Comprehensive Cancer Center; Gateway for Cancer Research; University of Iowa All 18 Years and older (Adult, Older Adult) 16 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201310772 01/01/2014 22/01/2019 01/01/2024 14/05/2013 26/07/2022 https://ClinicalTrials.gov/show/NCT01852890 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Ascorbic acid Safety and/or Dose Phase 1 DB00335 N
NCT03146962 High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies Recruiting Colorectal Cancer|Pancreatic Cancer|Lung Cancer Drug: Vitamin C Change in antitumor activity measured by pathologic response based on tumor regression grading in cohort A patients.; 3-month disease control rate (DCR) will be evaluated using RECIST v 1.1 in cohort B patients.; Maximal tolerated dose of high dose vitamin C in combination with Y90 radioembolization; Progression-free survival (PFS); Objective response rate (ORR); Assessment of pharmacokinetics of high dose vitamin C plasma levels concentrations; Safety of high dose vitamin C administration using CTCAE 4.03. Weill Medical College of Cornell University; Stand Up To Cancer All 18 Years and older (Adult, Older Adult) 78 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1610017688 29/03/2017 06/01/2023 06/01/2023 05/10/2017 10/04/2022 https://ClinicalTrials.gov/show/NCT03146962 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Multiple cancer types Multiple cancer types Ascorbic acid Other (specify) Phase 2 DB00335 N
NCT02420314 Pharmacological Ascorbate for Lung Cancer Active, not recruiting Carcinoma, Non-Small-Cell Lung Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid Tumor response; Progression free survival (PFS); Overall survival (OS); Adverse Event Frequency Joseph J. Cullen, MD, FACS; National Cancer Institute (NCI); National Institutes of Health (NIH); Holden Comprehensive Cancer Center; McGuff Pharmaceuticals, Inc.; University of Iowa All 18 Years and older (Adult, Older Adult) 55 Other; NIH; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201412760; 3P30CA086862 04/01/2015 12/01/2021 12/01/2024 17/04/2015 18/08/2022 https://ClinicalTrials.gov/show/NCT02420314 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Ascorbic acid Response rate Phase 2 DB00335 N
NCT02905591 A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC XACT-LUNG Recruiting Carcinoma, Non-Small-Cell Lung|Non-Small Cell Lung Cancer|Nonsmall Cell Lung Cancer|Non-Small-Cell Lung Carcinoma|NSCLC Drug: Radiation Therapy; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ascorbic Acid Progression rate at completion of radiation and chemotherapy; Tumor response; Progression free survival (PFS); Overall survival (OS); Adverse event frequency and categorization Joseph J. Cullen, MD, FACS; National Institutes of Health (NIH); National Cancer Institute (NCI); Holden Comprehensive Cancer Center; University of Iowa All 18 Years and older (Adult, Older Adult) 46 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201712770; 3P30CA086862; 5U01CA140206; 1P01CA217797-01A1 16/11/2018 12/01/2024 31/12/2026 19/09/2016 15/08/2022 https://ClinicalTrials.gov/show/NCT02905591 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Ascorbic acid Response rate Phase 2 DB00335 N
NCT01752491 A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme Active, not recruiting Glioblastoma|GBM|Glioblastoma Multiforme Drug: Ascorbate; Drug: Temozolomide; Radiation: Radiation therapy Number of grade 3, 4, 5 adverse events; Time to progression; Overall survival Joseph J. Cullen, MD, FACS; National Institutes of Health (NIH); National Cancer Institute (NCI); University of Iowa All 18 Years and older (Adult, Older Adult) 13 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201211713; P30CA086862; U01CA140206 04/01/2013 30/11/2015 31/12/2024 19/12/2012 26/07/2022 https://ClinicalTrials.gov/show/NCT01752491 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma Ascorbic acid Safety and/or Dose Phase 1 DB00335 N
NCT05184816 A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis Recruiting Leptomeningeal Metastases Drug: Deferoxamine (DFO) Frequency of dose-limiting toxicities (DLTs) during Phase Ia (Primary safety endpoint during dose-finding phase); Frequency of dose-limiting toxicities (DLTs) during Phase Ib (RP2D of IT-DFO in patients with LM from NSCLC); objective response rate (ORR) Memorial Sloan Kettering Cancer Center; Center for Experimental Therapeutics; F.M. KIRBY FOUNDATION All 18 Years and older (Adult, Older Adult) 35 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 21-378 22/12/2021 12/01/2024 12/01/2024 01/11/2022 16/09/2022 https://ClinicalTrials.gov/show/NCT05184816 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Deferoxamine Safety and/or Dose Phase 1 DB04932 N
NCT05077137 A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy TdVax Recruiting Melanoma Biological: Tetanus Diptheria Vaccine; Biological: Polio Boost Immunization Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy; Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies); Preliminary efficacy, as measured by objective response rate Duke University All 18 Years and older (Adult, Older Adult) 25 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Pro00108367 09/07/2021 09/01/2023 09/01/2024 14/10/2021 09/10/2022 https://ClinicalTrials.gov/show/NCT05077137 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Diphtheria vaccine; Tetanus vaccine Safety and/or Dose Phase 1 DB00975; DB00730 N
NCT04696029 DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma Recruiting Medulloblastoma Drug: Difluoromethylornithine Number of participants with event free survival (EFS) during study; Length of time that participants experience Overall Survival (OS); Determine the Overall Response Rate (ORR) of Participants using Modified RANO Criteria; Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Determine amount of DFMO in the CSF at 3 hours post dose Wake Forest University Health Sciences All up to 21 Years (Child, Adult) 118 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BCC016 29/03/2021 03/01/2028 03/01/2029 01/06/2021 08/04/2022 https://ClinicalTrials.gov/show/NCT04696029 Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS Medulloblastoma Eflornithine Response rate; OS; DFS/RFS/EFS Phase 2 DB06210 N
NCT02559778 Pediatric Precision Laboratory Advanced Neuroblastoma Therapy PEDS-PLAN Recruiting Neuroblastoma Drug: Ceritinib; Drug: dasatinib; Drug: sorafenib; Drug: vorinostat; Drug: DFMO Number of days from start of therapy to date of first relapse; Number of subjects that have a targeted agent chosen for treatment.; Number of subjects that receive 75 of dosing of medications while on study protocol during cycles 3-6.; Number of days that subjects remain alive; Overall Response Rate (ORR) of Participants by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans.; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; Amount of pain medicine required by Arm A versus Arm B; Number of subjects required to go off therapy due to treatment-related adverse events as assessed by CTCAE v4.0. Wake Forest University Health Sciences; Dell, Inc.; Beat NB Cancer Foundation; K C Pharmaceuticals Inc.; Team Parker for Life All up to 22 Years (Child, Adult) 500 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NMTRC012 09/01/2015 09/01/2027 09/01/2032 24/09/2015 27/09/2022 https://ClinicalTrials.gov/show/NCT02559778 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N Y United States Other Neuroblastoma Eflornithine DFS/RFS/EFS Phase 2 DB06210 N
NCT05055323 A Study to Determine if the Drug, Pyrvinium Pamoate, is Safe and Tolerable in Patients With Pancreatic Cancer Recruiting Resectable Pancreatic Ductal Adenocarcinoma|Stage 0 Pancreatic Cancer AJCC v8|Stage I Pancreatic Cancer AJCC v8|Stage IA Pancreatic Cancer AJCC v8|Stage IB Pancreatic Cancer AJCC v8|Stage II Pancreatic Cancer AJCC v8|Stage IIA Pancreatic Cancer AJCC v8|Stage IIB Pancreatic Cancer AJCC v8 Drug: Pyrvinium Pamoate Incidence of dose limited toxicity (DLT); Profile of pyrvinium pamoate (PP); Bioavailability of PP; Fatty tissue accumulation of PP Thomas Jefferson University All 18 Years and older (Adult, Older Adult) 18 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20F.041 29/07/2021 06/01/2023 06/01/2023 24/09/2021 08/03/2022 https://ClinicalTrials.gov/show/NCT05055323 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Pyrvinium Pamoate Safety and/or Dose; Biomarker Phase 1 DB01224 N
NCT03919292 Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca Recruiting Solid Tumor, Adult Drug: Neratinib; Drug: Divalproex Sodium Determination of Recommended Phase 2 Dose (RP2D); Evaluation of Treatment Related Adverse Events of Neratinib combined with Sodium Valproate; Solid Tumor Antitumor Effects; Glioblastoma Antitumor Effects; Progression Free Survival (PFS) Virginia Commonwealth University; Puma Biotechnology, Inc. All 18 Years and older (Adult, Older Adult) 113 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MCC-17-13821 05/01/2019 31/12/2023 31/12/2024 18/04/2019 23/09/2022 https://ClinicalTrials.gov/show/NCT03919292 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Valproic Acid Safety and/or Dose; PFS; Other (specify) Phase 1/2 DB00177 N
NCT05053750 TAME: A Pilot Study of Weekly Paclitaxel, Bevacizumab, and Tumor Associated Macrophage Targeted Therapy (Zoledronic Acid) in Women With Recurrent, Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Recruiting Epithelial Ovarian|Fallopian Tube|Primary Peritoneal Cancer Drug: Paclitaxel/Bev (control); Drug: Paclitaxel/Bev + ZA (experimental) To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab and ZA relative to weekly paclitaxel/bevacizumab M.D. Anderson Cancer Center; Gateway for Cancer Research; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 30 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-0694; NCI-2021-04298 14/12/2021 31/03/2023 31/03/2023 22/09/2021 08/11/2022 https://ClinicalTrials.gov/show/NCT05053750 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Fallopian Tube Cancer; Ovarian Epithelial Cancer; Primary Peritoneal Cancer Zoledronic Acid Biomarker Phase 1 N
NCT04046094 Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients Active, not recruiting Bladder Cancer Drug: Ascorbic Acid Post Treatment Pathological Staging; Overall change in patient-reported quality of life outcomes; Disease free survival rate (DFS) among participants University of Kansas Medical Center All 18 Years and older (Adult, Older Adult) 16 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IIT-2019-IVC_CarboGem 17/10/2019 09/12/2022 08/01/2024 08/06/2019 26/09/2022 https://ClinicalTrials.gov/show/NCT04046094 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Bladder Cancer Ascorbic acid DFS/RFS/EFS; QoL; Other (specify) Phase 1/2 DB00335 N
NCT03508726 High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas Active, not recruiting Soft Tissue Sarcoma Drug: Ascorbate Incidence of dose limiting toxicities (DLTs) using CTCAE, Version 4.0; Tumor response as assessed by pathological complete response rates (pCR); Disease progression as measured by time to disease progression (TTP); Overall response rate as measured by RECIST 1.1; Overall survival estimated using the Kaplan-Meier Method; Skin toxicity; Labile iron; Evaluate diffusion weighted imaging sequences Varun Monga, MD; University of Iowa All 18 Years and older (Adult, Older Adult) 25 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201901810 27/06/2019 06/03/2022 06/01/2024 26/04/2018 10/12/2022 https://ClinicalTrials.gov/show/NCT03508726 Localised/Locoregional Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma Any soft tissue sarcoma Ascorbic acid Safety and/or Dose; Response rate Phase 1/2 DB00335 N
NCT02553447 Cholecalciferol in Treating Patients With Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency Active, not recruiting Chronic Lymphocytic Leukemia|Non-Hodgkin Lymphoma|Untreated Chronic Lymphocytic Leukemia|Vitamin D Deficiency Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis Progression-free survival; Incidence of adverse events and serious events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0; Overall survival University of Nebraska; National Cancer Institute (NCI) All 19 Years and older (Adult, Older Adult) 197 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 556-15; NCI-2015-01502; P30CA036727 19/10/2015 24/03/2025 24/03/2025 17/09/2015 08/08/2022 https://ClinicalTrials.gov/show/NCT02553447 Any/All Stages Hospital/University/Research Institute Y Y N United States Lymphoma; Leukemia Non-Hodgkin Lymphoma, Adult; Chronic Lymphocytic Leukemia Cholecalciferol PFS Phase 1 Not found in DrugBank N
NCT04442412 Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy FIL_PREVID Recruiting Diffuse Large B-Cell Lymphoma|Elderly Patients Drug: Vitamin D3 (Cholecalciferol); Drug: RCHOP o R-miniCHOP at standard doses Progression-Free Survival; Overall Survival; Event Free Survival; Response rate; Early death rate; Rate of ECOG changes after prephase; Rate of patients who maintain 25(OH)VitD levels; Rate of 25(OH)VitD correction (VitD supplementation arm); time-to-deterioration physical functioning and fatigue Fondazione Italiana Linfomi ONLUS; GRADE Onlus All 65 Years and older (Older Adult) 430 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment FIL_PREVID 23/03/2021 09/01/2025 09/01/2030 22/06/2020 26/08/2022 https://ClinicalTrials.gov/show/NCT04442412 Adjuvant/Maintenance Any/All Stages Collaborative Group Y N N Italy Lymphoma Non-Hodgkin Lymphoma, Adult Cholecalciferol PFS Phase 3 Not found in DrugBank N
NCT02715609 Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Active, not recruiting Glioblastoma Multiforme Drug: Disulfiram; Drug: Copper Gluconate; Procedure: Surgery; Radiation: Radiation; Drug: Temozolomide Maximum tolerated dose (MTD) of the regimen (dose-escalation phase only); Overall survival (dose-expansion phase only); Toxicity associated with DSF when given concurrently with radiation therapy and temozolomide as measured by the grade and frequency of adverse events (dose- escalation phase only); Intratumoral drug uptake of DSF and its metabolites in resected GBM tissue (dose-escalation phase only); Proteasome inhibition of DSF on GBM tissues (dose-escalation phase only); Effect of DSF on DNA breaks on GBM tissues (dose-escalation phase only); Time to tumor progression (TTP) (dose-escalation phase only); Rate of pseudo-progression (PsP) (dose-escalation phase only); Progression-free survival (PFS); Overall survival (OS) (dose-escalation phase only); Active DSF metabolite concentration in plasma and tumor tissues (dose-expansion phase only); Pharmacodynamic studies on glutamate metabolism as measured by measurement of glutamine levels in plasma and tumor tissues (dose-escalation phase only); Pharmacodynamic studies on glutamate metabolism as measured by measurement of glutamate levels in plasma and tumor tissues (dose-escalation phase only); Pharmacodynamic studies on glutamate metabolism as measured by measurement of aspartate levels in plasma and tumor tissues (dose escalation phase only); Pharmacodynamic studies on glutamate metabolism as measured by measurement of glucose levels in plasma and tumor tissues (dose escalation phase only); Pharmacodynamic studies on glutamate metabolism as measured by measurement of lactate levels in plasma and tumor tissues (dose escalation phase only) Washington University School of Medicine All 18 Years and older (Adult, Older Adult) 35 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201604115 15/06/2016 28/02/2025 28/02/2025 22/03/2016 25/07/2022 https://ClinicalTrials.gov/show/NCT02715609 Any/All Stages Hospital/University/Research Institute N N N United States CNS Glioblastoma Disulfiram Safety and/or Dose; OS Phase 1/2 DB00843 N
NCT05236036 Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma Recruiting Astrocytoma|Glioblastoma|Glioblastoma, IDH-Wildtype|MGMT-Unmethylated Glioblastoma|Recurrent Glioblastoma Drug: Mycophenolate Mofetil; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy; Drug: Temozolomide Maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) for mycophenolate mofetil (MMF) (Group 1); MTD/RP2D for MMF (Group 2); Frequency of adverse events; Progression Free Survival (PFS); Overall survival (OS); Overall response rate (ORR); Quality of life (QOL) Northwestern University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 60 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NU 21C01; NCI-2021-12424; STU00215766; P30CA060553 08/08/2022 01/03/2025 01/03/2027 02/11/2022 25/08/2022 https://ClinicalTrials.gov/show/NCT05236036 Any/All Stages Hospital/University/Research Institute N N N United States CNS Glioblastoma Mycophenolate Safety and/or Dose Phase 1 DB08813 N
NCT03035331 Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma Active, not recruiting Aggressive Non-Hodgkin Lymphoma|Indolent Non-Hodgkin Lymphoma|Recurrent Diffuse Large B-Cell Lymphoma|Recurrent Follicular Lymphoma|Recurrent Mantle Cell Lymphoma|Recurrent Marginal Zone Lymphoma|Recurrent Non-Hodgkin Lymphoma|Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma|Recurrent T-Cell Non-Hodgkin Lymphoma|Small Lymphocytic Lymphoma Procedure: Cryosurgery; Biological: Dendritic Cell Therapy; Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab; Biological: Pneumococcal 13-valent Conjugate Vaccine; Other: Quality-of-Life Assessment Maximum tolerated dose (MTD); Proportion of complete responses of combination therapy with pembrolizumab, cryoablation, and intra-tumor injection of autologous dendritic cells (DC) at maximum tolerated dose (MTD) dose; Complete response; Progression free survival; Treatment free survival; Duration of response; Disease free survival rate; Overall survival; Incidence of adverse events; Quality of life Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 11 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MC1685; NCI-2017-00113; P30CA015083; P50CA097274 27/03/2017 07/01/2023 07/01/2023 30/01/2017 08/11/2022 https://ClinicalTrials.gov/show/NCT03035331 Localised/Locoregional; Recurrent/Refractory Company N N N United States Lymphoma Non-Hodgkin Lymphoma, Adult Pneumococcal vaccine Safety and/or Dose; Response rate; PFS; Biomarker Phase 1/2 DB01263 N
2021-006689-18 An open randomized phase II clinical trial evaluating the safety and efficacy of rapamycin in the treatment of gliomas high-grade malignant gliomas in children as part of the establishment management of rare and ultra rare diseases of the central nervous system associated with mTOR pathway activation: BraimTOR- ONKO BraimTOR-ONKO high grade glioma Drug: Rapamune 1mg/ml oral solution The primary safety endpoint of rapamycin will be the assessment of the incidence of 3 and 4 grade adverse reactions (according to the CTCAE classification) during the treatment phase and follow-up. The Children's Memorial Health Institute All Under 18; Elderly 65+ 50 Medical Research Agency - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-006689-18/PL Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N Y Poland CNS Any CNS cancers Sirolimus Safety and/or Dose Phase 2 DB01261 N
NCT02467582 Adjuvant Aspirin Treatment for Colon Cancer Patients Active, not recruiting Colon Cancer Drug: Aspirin; Drug: Placebo Disease-free survival (DFS); Time to recurrence (TTR); Overall survival (OS); Cancer-specific survival (CSS); Adverse events (AEs) Swiss Group for Clinical Cancer Research; European Organisation for Research and Treatment of Cancer - EORTC; Central European Society for Anticancer Drug Research All 18 Years and older (Adult, Older Adult) 185 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment SAKK 41/13 - Aspirin; SNCTP000001339; 2015-001482-57 06/09/2016 12/01/2024 12/01/2024 06/10/2015 01/10/2023 https://ClinicalTrials.gov/show/NCT02467582 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Switzerland GI Colon Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 3 DB01048 N
NCT03602235 High Dose Ascorbic Acid for Plasma Cell Disorders Recruiting Multiple Myeloma Other: Ascorbate; Drug: Melphalan Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03; Rate of minimal residual disease (MRD) negativity through bone marrow testing and imaging; Overall response rate based on International Myeloma Working Group (IMWG) criteria; Categorize and quantify adverse events compared to historical control; Oxidative stress parameters in plasma through blood testing Michael Tomasson; University of Iowa All 18 Years and older (Adult, Older Adult) 9 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201804754 03/05/2019 31/08/2023 31/08/2024 26/07/2018 12/08/2022 https://ClinicalTrials.gov/show/NCT03602235 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Ascorbic acid Safety and/or Dose Phase 1 DB00335 N
NCT04677816 Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Recruiting Triple Negative Breast Cancer|Vitamin D Deficiency|Invasive Breast Cancer Drug: Standard of Care Neoadjuvant Chemotherapy; Dietary Supplement: Vitamin D3; Other: Drug Diary Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group; Number of Participants with Residual Cancer Burden (RCB) Index - Vitamin D Supplementation Group; Number of Participants with Residual Cancer Burden (RCB) Index - Observational Arm; Accrual Rate; Participation Rate; Retention Rate; Adherence Rate; Number of Adverse Events; Change in Vitamin D Receptor (VDR) Expression; Change in Fecal Microbiomes; Change in Mammary Gland Microbiomes Wake Forest University Health Sciences; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 50 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00074154; WFBCCC 98121; P30CA012197 22/10/2021 07/01/2023 07/01/2024 21/12/2020 02/09/2023 https://ClinicalTrials.gov/show/NCT04677816 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Breast Cancer - TNBC Cholecalciferol Response rate; Biomarker Phase 2 Not found in DrugBank N
NCT04839731 Combination 5-FU / Calcipotriene Cream for SCCIS/SCC Recruiting Squamous Cell Carcinoma Drug: Combination topical 5-fluorouracil 5 / calcipotriene 0.005 cream; Drug: Nourivan Base Cream Cancer resolution on histopathology; Final scar length; Cosmetic appearance Carilion Clinic All 18 Years to 100 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment IRB-19-691 14/04/2021 12/01/2023 12/01/2023 04/09/2021 13/02/2023 https://ClinicalTrials.gov/show/NCT04839731 Localised/Locoregional Hospital/University/Research Institute Y N N United States Skin Other skin cancer Calcipotriol Response rate Phase 1 DB00136 N
NCT02139397 Study of DFMO in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma Active, not recruiting Neuroblastoma Recurrent Drug: DFMO; Drug: Bortezomib Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Determine the Overall Response Rate (ORR) of Participants using RECIST criteria; Determine the Progression Free Survival (PFS) of Participants using days until progression; Correlate PET scan changes with Progression Free Survival; Biology studies; Correlate urinary polyamine levels with response and progression of disease in neuroblastoma. Wake Forest University Health Sciences; Beat NB Cancer Foundation; Because of Ezra; K C Pharmaceuticals Inc. All up to 21 Years (Child, Adult) 16 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NMTRC010 05/01/2014 07/01/2023 12/01/2023 15/05/2014 23/01/2023 https://ClinicalTrials.gov/show/NCT02139397 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Other Neuroblastoma Eflornithine Safety and/or Dose Phase 1/2 DB06210 N
NCT02176902 Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer Active, not recruiting Adenocarcinoma of the Prostate|Stage I Prostate Cancer|Stage IIA Prostate Cancer|Stage IIB Prostate Cancer Behavioral: behavioral dietary intervention; Dietary Supplement: omega-3 fatty acid; Other: laboratory biomarker analysis Decipher score in one year prostate biopsy tissue sample; Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer); Serum PSA; Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies); Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay); Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score; Compliance, defined as having taken 80 or more of the daily fish oil throughout the trial determined based on pill count; Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0; Sample storage for future research Jonsson Comprehensive Cancer Center; National Cancer Institute (NCI); Pharmavite LLC; Seafood Industry Research Fund Male 50 Years to 80 Years (Adult, Older Adult) 106 Other; NIH; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention 13-000432; NCI-2014-01257; P50CA092131 11/01/2014 11/01/2023 11/01/2024 27/06/2014 02/09/2023 https://ClinicalTrials.gov/show/NCT02176902 Localised/Locoregional Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Omega 3 Biomarker Other DB00338 N
NCT03428477 EPA for Metastasis Trial 2 EMT2 Recruiting Liver Metastasis|Colon Cancer Drug: Icosapent Ethyl; Other: Placebo Progression Free Survival (PFS); Overall Survival (OS); Safety and Tolerability of Icosapent Ethyl; Patient reported quality of life 1; Patient reported quality of life 2; Patient reported quality of life 3; New Primary Cancers Mark A Hull, PhD FRCP; Yorkshire Cancer Research; Amarin Pharma Inc.; University of Leeds All 18 Years and older (Adult, Older Adult) 448 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention MO16/053 05/02/2018 30/11/2025 30/04/2026 02/09/2018 11/08/2022 https://ClinicalTrials.gov/show/NCT03428477 Adjuvant/Maintenance Advanced/Metastatic Collaborative Group Y N N United Kingdom GI Colon Cancer; Rectal Cancer Omega 3 Safety and/or Dose; PFS; OS; QoL Phase 3 DB00338 N
NCT01351896 Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Active, not recruiting Ann Arbor Stage I Small Lymphocytic Lymphoma|Ann Arbor Stage II Small Lymphocytic Lymphoma|Chronic Lymphocytic Leukemia|Chronic Lymphocytic Leukemia With Unmutated Immunoglobulin Heavy Chain Variable-Region Gene|Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable-Region Gene|Stage 0 Chronic Lymphocytic Leukemia|Stage I Chronic Lymphocytic Leukemia|Stage II Chronic Lymphocytic Leukemia Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Other: Pharmacological Study; Biological: Pneumococcal Polyvalent Vaccine Proportion of patients who achieve an antibody response; Seroconversion rates; Antibody titre levels for each of the serotypes; Complete response rate; Time to first treatment; Overall survival; Progression-free survival; Incidence of adverse events; Pharmacokinetic (PK) parameters of lenalidomide; Change in serum immunoglobulin; Change in anti-tumor antibody levels National Cancer Institute (NCI) All 18 Years to 79 Years (Adult, Older Adult) 48 NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2011-02584; CDR0000698438; OSU 10156; 2011C0005; 8834; N01CM00070; N01CM62207; P01CA095426; P30CA016058; P50CA140158 09/08/2011 31/12/2024 31/12/2024 05/11/2011 26/01/2023 https://ClinicalTrials.gov/show/NCT01351896 Localised/Locoregional Hospital/University/Research Institute N Y N United States Lymphoma; Leukemia Lymphoma - Other; Chronic Lymphocytic Leukemia Pneumococcal vaccine Safety and/or Dose; PFS; OS; Biomarker Phase 2 DB01263 N
NCT00873275 Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer Active, not recruiting Colorectal Cancer Biological: bevacizumab; Drug: FOLFOX regimen; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Drug: ursodiol; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: western blotting; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: pharmacological study; Procedure: positron emission tomography (PET) Maximum-tolerated dose of ursodiol; Toxicities as assessed by NCI CTCAE 3.0; Survival; Time to failure; Pharmacokinetics of ursodiol City of Hope Medical Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 11 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 08005; P30CA033572; CHNMC-08005; CDR0000637521; NCI-2010-00926 03/11/2009 25/09/2012 13/01/2025 04/01/2009 28/11/2022 https://ClinicalTrials.gov/show/NCT00873275 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Rectal Cancer; Colon Cancer Ursodeoxycholic Acid Safety and/or Dose; OS; Biomarker Phase 1 DB01610 N
NCT03073785 Hypofractionated Stereotactic Body Radiation Therapy and Fluorouracil or Capecitabine With or Without Zoledronic Acid in Treating Patients With Locally Advanced Pancreatic Cancer Recruiting Pancreatic Adenocarcinoma|Recurrent Pancreatic Carcinoma|Stage I Pancreatic Cancer AJCC v6 and v7|Stage IA Pancreatic Cancer AJCC v6 and v7|Stage IB Pancreatic Cancer AJCC v6 and v7|Stage II Pancreatic Cancer AJCC v6 and v7|Stage IIA Pancreatic Cancer AJCC v6 and v7|Stage IIB Pancreatic Cancer AJCC v6 and v7|Stage III Pancreatic Cancer AJCC v6 and v7|Stage IV Pancreatic Cancer AJCC v6 and v7 Drug: Capecitabine; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Radiation: Stereotactic Body Radiation Therapy; Drug: Zoledronic Acid Local control; Maximum tolerated dose of zoledronic acid determined by dose limiting toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0; Local failure-free survival will be compared between patients with and without Zometa; Overall survival will be compared between patients with and without Zometa; Surgical complete resection (negative margin) rate will be compared between patients with and without Zometa; Pathologic response for patients who undergo resection will be compared between patients with and without Zometa; The change of tumor size after SBRT will be compared between patients with and without Zometa; The change of max and average SUV after SBRT will be compared between patients with and without Zometa.; Tumor and organ motion Chi Lin, MD, PhD; National Cancer Institute (NCI); University of Nebraska All 19 Years and older (Adult, Older Adult) 44 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 552-16; NCI-2016-01360; P30CA036727 16/09/2016 12/01/2024 12/01/2024 03/08/2017 25/01/2023 https://ClinicalTrials.gov/show/NCT03073785 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Zoledronic Acid Safety and/or Dose; OS; DFS/RFS/EFS; Biomarker; Other (specify) Phase 2 N
NCT04534218 Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer REPROGRAM-01 Active, not recruiting Colo-rectal Cancer|Metastatic Cancer Drug: Regorafenib; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Aspirin objective response rate Centre Hospitalier Universitaire de Besancon; Bayer All 18 Years and older (Adult, Older Adult) 49 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2020/490 16/10/2020 07/01/2023 01/01/2024 09/01/2020 02/10/2023 https://ClinicalTrials.gov/show/NCT04534218 Advanced/Metastatic Hospital/University/Research Institute N N N France GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Response rate Phase 2 DB01048 N
NCT01787409 Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency Active, not recruiting Aggressive Non-Hodgkin Lymphoma|Anaplastic Large Cell Lymphoma|Angioimmunoblastic T-Cell Lymphoma|Chronic Lymphocytic Leukemia|Diffuse Large B-Cell Lymphoma|Enteropathy-Associated T-Cell Lymphoma|Hepatosplenic T-Cell Lymphoma|Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma|Mediastinal (Thymic) Large B-Cell Lymphoma|Nasal Type Extranodal NK/T-Cell Lymphoma|Peripheral T-Cell Lymphoma, Not Otherwise Specified|Primary Cutaneous Anaplastic Large Cell Lymphoma|Refractory Anaplastic Large Cell Lymphoma|Small Lymphocytic Lymphoma|Subcutaneous Panniculitis-Like T-Cell Lymphoma Dietary Supplement: Cholecalciferol; Other: Laboratory Biomarker Analysis Event free survival (EFS) (Study I); Treatment free status (Study II); Bio-R response rate (Study II); EFS time (Study I); OS (Study II); Overall response rate (Study II); Overall survival (OS) time (Study I); Time to first treatment (Study II) Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 315 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LS1293; NCI-2013-00037; P50CA097274 03/06/2013 09/04/2023 09/04/2023 02/08/2013 18/01/2023 https://ClinicalTrials.gov/show/NCT01787409 Any/All Stages Hospital/University/Research Institute N N N United States Lymphoma Any lymphoma Cholecalciferol DFS/RFS/EFS Other Not found in DrugBank N
NCT05381597 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer Recruiting Superficial Basal Cell Carcinoma|Squamous Cell Carcinoma in Situ Drug: Combination cream of 5-fluorouracil and calcipotriene; Drug: 5-fluorouracil cream Clearance rate of cancer lesions at 3 months; Clearance rate of cancer lesions at 3 years; Percent of participants that experience pain during treatment; Severity of pain during treatment; Percent of participants that experience redness during treatment; Severity of redness during treatment; Day of worst redness; Percent of participants who experienced scaling/flaking; Percent of participants who experienced skin itching; Percent of participants who experienced skin burning; Participant compliance with treatment; Participant satisfaction with treatment; Recurrence rate of cancer lesions at 1 year; Recurrence rate of cancer lesions at 3 years Boston University All 18 Years and older (Adult, Older Adult) 200 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment H-42421 15/10/2022 06/01/2025 06/01/2025 19/05/2022 14/11/2022 https://ClinicalTrials.gov/show/NCT05381597 Localised/Locoregional Hospital/University/Research Institute Y N N United States Skin Basal Cell Carcinoma Calcipotriol Response rate Phase 2/3 DB00136 N
NCT03520790 Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer Active, not recruiting Pancreatic Cancer Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Paricalcitol; Other: Placebo Assess adverse events (per CTCAE v4.0 criteria); Overall survival; Response rate; Progression free survival Dana-Farber Cancer Institute; Stand Up To Cancer; Lustgarten Foundation; American Association for Cancer Research All 18 Years and older (Adult, Older Adult) 112 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment 18-021 12/05/2018 30/11/2023 30/11/2025 05/11/2018 01/11/2023 https://ClinicalTrials.gov/show/NCT03520790 Advanced/Metastatic Hospital/University/Research Institute Y Y N United States GI Pancreatic Cancer Paricalcitol Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00715 N
NCT05210374 Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas Recruiting Relapsed Sarcomas Drug: Disulfiram; Drug: Copper Gluconate; Drug: Liposomal Doxorubicin (Doxil) Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines; Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin; Number of participants able to take at least 80 of the drug doses during the first cycle of treatment; Number of dose-limiting toxicities (DLT); Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0; Percent of participants with tumor response evaluated using RECIST v1.1; Median Overall Survival (OS); Median Event free survival; Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]; Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]; Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites] Case Comprehensive Cancer Center All 1 Year and older (Child, Adult, Older Adult) 24 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CASE1720 24/01/2023 10/01/2023 11/01/2023 27/01/2022 26/01/2023 https://ClinicalTrials.gov/show/NCT05210374 Recurrent/Refractory Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma; Bone Sarcoma Any Bone Sarcomas Disulfiram Safety and/or Dose Phase 1 DB00843 N
NCT02068586 Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma Active, not recruiting Ciliary Body and Choroid Melanoma, Medium/Large Size|Ciliary Body and Choroid Melanoma, Small Size|Iris Melanoma|Stage I Intraocular Melanoma|Stage IIA Intraocular Melanoma|Stage IIB Intraocular Melanoma|Stage IIIA Intraocular Melanoma|Stage IIIB Intraocular Melanoma|Stage IIIC Intraocular Melanoma|Stage I Uveal Melanoma AJCC V7|Stage II Uveal Melanoma AJCC V7|Stage III Uveal Melanoma AJCC V7 Drug: Sunitinib; Drug: Valproic Acid; Drug: Sunitinib Malate; Drug: Sunitinib Malate + Valproic Acid Overall survival (Cohort 1); Relapse-free survival (RFS) (Cohort 2 and 3); Relapse-free survival (Cohort 1); Overall survival (Cohort 2); Tolerability, defined as the proportion of patients able to complete 6 months of treatment, including those who underwent dose reduction; Incidence of toxicity assessed according to the National Institute of Health Common Terminology Criteria for Adverse Events (NIH CTCAE) version 4.0; Quality of life (QOL) assessed by Functional Assessment of Cancer Therapy-General (FACT-G) questionnaires Sidney Kimmel Cancer Center at Thomas Jefferson University; Pfizer; National Cancer Institute (NCI); Thomas Jefferson University All 18 Years and older (Adult, Older Adult) 210 Other; Industry; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 13P.377; 2013-047; P30CA056036 19/11/2014 30/06/2023 30/06/2023 21/02/2014 02/06/2023 https://ClinicalTrials.gov/show/NCT02068586 Localised/Locoregional Hospital/University/Research Institute N Y N United States Skin Other skin cancer Valproic Acid Safety and/or Dose; OS; DFS/RFS/EFS; QoL Phase 2 DB00177 N
NCT05637567 Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head ASAP Not yet recruiting Pancreatic Cancer Resectable Drug: Acetylsalicylic acid; Drug: Placebo Hematogenous metastases-free survival; Overall survival; Cancer-specific survival; Disease-free survival; Intraoperative blood loss; Duration of surgery; Perioperative surgical complications; Perioperative medical complications; R status; Number of resected lymph nodes German Cancer Research Center All 18 Years to 80 Years (Adult, Older Adult) 458 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment DKFZ-2022-006 07/01/2023 06/01/2030 12/01/2030 12/05/2022 12/06/2022 https://ClinicalTrials.gov/show/NCT05637567 Perioperative Localised/Locoregional Hospital/University/Research Institute Y N N Germany GI Pancreatic Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS; Other (specify) Phase 3 DB01048 N
NCT05667415 Treatment of Advance Gastric Cancer With Disulfiram Not yet recruiting Chemotherapy Advanced Gastric Cancer Cisplatin Disulfiram Drug: disulfiram and cisplatin; Drug: cisplatin Complete response (CR); Partial response (PR); Stable disease (SD); Disease progression (PD) First People's Hospital of Hangzhou; College of Pharmaceutical Sciences at Zhejiang University; The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University All 18 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20221212 06/01/2023 31/12/2025 30/06/2026 28/12/2022 28/12/2022 https://ClinicalTrials.gov/show/NCT05667415 Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Gastric Cancer Disulfiram Response rate Other DB00843 N
NCT05694936 Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer Recruiting Metastatic Colorectal Cancer Drug: Sodium Valproate; Drug: Panitumumab; Drug: Cetuximab Progression free survival; Overall Survival; Objective response rates (ORRs); Quantification of the incidence of treatment-emergent adverse events according to CTCAE V5.0 Australasian Gastro-Intestinal Trials Group; Olivia Newton-John Cancer Research Institute All 18 Years and older (Adult, Older Adult) 90 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VADER 23/01/2023 09/01/2024 09/01/2024 23/01/2023 25/01/2023 https://ClinicalTrials.gov/show/NCT05694936 Advanced/Metastatic Collaborative Group Y N N Australia GI Colon Cancer; Rectal Cancer Valproic Acid PFS Phase 2 DB00177 N
NCT05036109 DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease Recruiting Colorectal Cancer|Colon Cancer Drug: Aspirin; Drug: Vitamin D; Dietary Supplement: Diet; Other: Physical Activity; Behavioral: Behavioral Support Counseling Sessions To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease M.D. Anderson Cancer Center All 18 Years and older (Adult, Older Adult) 17 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-0320; NCI-2021-09193 10/12/2021 31/05/2023 31/05/2023 09/05/2021 04/12/2023 https://ClinicalTrials.gov/show/NCT05036109 Other (specify) Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid; Cholecalciferol Biomarker Phase 1 DB01048; Not found in DrugBank N
NCT03899987 Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery Suspended Prostate Adenocarcinoma|Stage I Prostate Cancer AJCC v8|Stage II Prostate Cancer AJCC v8|Stage IIA Prostate Cancer AJCC v8|Stage IIB Prostate Cancer AJCC v8|Stage IIC Prostate Cancer AJCC v8|Stage III Prostate Cancer AJCC v8|Stage IIIA Prostate Cancer AJCC v8|Stage IIIB Prostate Cancer AJCC v8|Stage IIIC Prostate Cancer AJCC v8 Drug: Aspirin; Procedure: Radical Prostatectomy; Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod Count of tumor infiltrating CD8+ lymphocytes; Pathologic response; Number of patients with Surgical margin positivity; PSA response; Incidence of treatment-related adverse events Roswell Park Cancer Institute; AIM ImmunoTech Inc. Male 18 Years and older (Adult, Older Adult) 30 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 77318; NCI-2019-01192 29/11/2019 29/11/2023 29/11/2024 04/02/2019 15/05/2023 https://ClinicalTrials.gov/show/NCT03899987 Localised/Locoregional Hospital/University/Research Institute Y Y N United States Urological Prostate Cancer Acetylsalicylic Acid Safety and/or Dose; Response rate; Biomarker Phase 2 DB01048 N
NCT05501548 Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer Not yet recruiting Prostate Cancer|Castration-resistant Prostate Cancer Drug: Olaparib; Dietary Supplement: Vitamin C PSA50 response; Safety and tolerability of olaparib in combination with IV ascorbic acid in patients with mCRPC; PSA doubling time in patients with mCRPC receiving olaparib in combination with IV ascorbic acid; Radiographic progression free survival (rPFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid; PSA progression free survival (PSA PFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid; Overall survival of patients with mCRPC receiving olaparib in combination with IV ascorbic acid Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; AstraZeneca; McGuff Pharmaceuticals, Inc.; The Marcus Foundation Male 18 Years and older (Adult, Older Adult) 15 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment J21127; IRB00292465; ESR 19-20448 05/01/2023 03/01/2028 03/01/2028 15/08/2022 04/07/2023 https://ClinicalTrials.gov/show/NCT05501548 Advanced/Metastatic Hospital/University/Research Institute N N N United States Urological Prostate Cancer Ascorbic acid PFS; Biomarker Phase 2 DB00335 N
NCT03541486 A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients XACT-PANC-2 Not yet recruiting Pancreatic Neoplasm Drug: Ascorbate; Drug: Gemcitabine; Radiation: radiation therapy Overall survival (OS); Progression free survival (PFS); Toxicity over time (ToxT); Metastasis free survival (MFS); Resection rate; Adverse event frequency and categorization; Patient reported outcome measure: Vaizey Incontinence questionnaire; Quality of life: Modified Inflammatory Bowel Disease questionnaire; Pathologic characteristics Joseph J. Cullen, MD, FACS; Holden Comprehensive Cancer Center; University of Iowa All 18 Years and older (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment XACT-PANC-2 31/12/2025 31/12/2029 31/12/2030 30/05/2018 17/02/2023 https://ClinicalTrials.gov/show/NCT03541486 Advanced/Metastatic Hospital/University/Research Institute Y N N United States GI Pancreatic Cancer Ascorbic acid PFS; OS; Recurrence rate Phase 2 DB00335 N
NCT04634227 Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot) Recruiting Sarcoma|Soft Tissue Sarcoma|Unresectable Soft Tissue Sarcoma|Metastatic Bone Tumor|Bone Sarcoma Drug: Ascorbate Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation; Assess overall survival of patients with unresectable or metastatic soft tissue and bone sarcoma treated with high dose ascorbate when administered intravenously concurrently with gemcitabine; Determine the tumor response as per RECIST 1.1 criteria; Incidence of Adverse Events (AE) Per CTCAE 4.03 Varun Monga, MD; University of Iowa Adolescent and Young Adult (AYA) Cancer Program; St. Baldrick's Foundation; University of Iowa All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201802800 (Pilot) 24/11/2020 31/12/2023 31/12/2023 18/11/2020 16/02/2023 https://ClinicalTrials.gov/show/NCT04634227 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma; Bone Sarcoma Any soft tissue sarcoma; Any Bone Sarcomas Ascorbic acid PFS Phase 1 DB00335 N
NCT04687176 Frontline Oral Arsenic Trioxide for APL Recruiting Acute Promyelocytic Leukemia Drug: Oral Arsenic Trioxide Formulation Relapse-free survival (RFS); Event-free survival (EFS); Overall survival; Treatment toxicities The University of Hong Kong All Child, Adult, Older Adult 100 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment APL003 01/01/2021 31/12/2025 30/06/2026 29/12/2020 23/05/2023 https://ClinicalTrials.gov/show/NCT04687176 Localised/Locoregional Hospital/University/Research Institute N N N Hong Kong Leukemia Leukemia - Other Ascorbic acid DFS/RFS/EFS Phase 2 DB00335 N
NCT03418038 Ascorbic Acid and Combination Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma or Clonal Cytopenia of Undetermined Significance Recruiting Clonal Cytopenia of Undetermined Significance|High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements|Recurrent Diffuse Large B-Cell Lymphoma|Recurrent Hodgkin Lymphoma|Recurrent Lymphoma|Refractory Diffuse Large B-Cell Lymphoma|Refractory Lymphoma Dietary Supplement: Ascorbic Acid; Drug: Carboplatin; Drug: Cisplatin; Drug: Cytarabine; Drug: Dexamethasone; Drug: Etoposide; Drug: Gemcitabine Hydrochloride; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Oxaliplatin; Other: Placebo Administration; Other: Questionnaire Administration; Biological: Rituximab Overall response rate (ORR) (Arms A and B); ORR (Arm C); Hematologic response (HI) rate (Arm D); Clinical benefit rate (Arms A, B, and C); Overall survival; Progression-free survival; Percent of transplant eligible patients proceeding to transplant (Arms A, B and C); Transfusion dependency (Arm D); Incidence of adverse events; Continued salvage therapy beyond cycle 2 (Arm A, B and C) Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 55 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment LS1781; NCI-2018-00057; P30CA015083 23/03/2018 15/03/2024 15/03/2024 02/01/2018 05/03/2023 https://ClinicalTrials.gov/show/NCT03418038 Recurrent/Refractory Hospital/University/Research Institute Y Y N United States Lymphoma Any lymphoma Ascorbic acid Response rate; PFS; OS Phase 2 DB00335 N
NCT04094688 Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer SOLARIS Recruiting Colorectal Adenocarcinoma Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Leucovorin Calcium; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Irinotecan; Dietary Supplement: Cholecalciferol; Other: Quality-of-Life Assessment; Other: Questionnaire Administration Progression-free survival (PFS); Objective response; Overall survival (OS); Incidence of adverse events; Physical activity (PA) and progression-free survival (PFS); Incidence of vitamin D3 deficiency; 25(OH)D levels; Prognostic effect of highest achieved 25(OH)D Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 400 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment A021703; NCI-2019-01034; U10CA180821 30/09/2019 01/01/2024 07/01/2024 19/09/2019 24/03/2023 https://ClinicalTrials.gov/show/NCT04094688 Palliative Advanced/Metastatic Collaborative Group Y N N United States GI Colon Cancer; Rectal Cancer Cholecalciferol PFS Phase 3 Not found in DrugBank N
NCT03078855 A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma ILyAD Active, not recruiting Follicular Lymphoma|Small Lymphocytic Lymphoma|Marginal Zone Lymphoma|Mucosal-Associated Lymphoid Tissue Lymphoma Dietary Supplement: Vitamin D; Biological: Rituximab; Other: Placebo Time to progression or death; Time from randomization to death; Response to rituximab defined as reduction of lymphoma burden by at least 50 Jonathan Friedberg; National Institutes of Health (NIH); National Cancer Institute (NCI); University of Rochester All 18 Years and older (Adult, Older Adult) 211 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care 66593; R01CA214890 09/07/2017 09/01/2023 09/01/2023 13/03/2017 04/07/2023 https://ClinicalTrials.gov/show/NCT03078855 Adjuvant/Maintenance Any/All Stages Hospital/University/Research Institute Y N N United States Lymphoma Non-Hodgkin Lymphoma, Adult Cholecalciferol PFS Phase 3 Not found in DrugBank N
NCT03467789 Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma Active, not recruiting Basal Cell Carcinoma|Basal Cell Nevus Syndrome Drug: Dietary Vitamin D3 pre-treatment; Radiation: Photodynamic therapy; Drug: Serum Maintenance Vitamin D3 BCC: Rate of tumor clearance; BCC: Level of protoporphyrin IX (PpIX) accumulation in BCC lesions; Serum 25-hydroxy-vitamin D3 (25OH-D3) levels; Number of patients with active form of leukocyte DNA vitamin D Receptor (VDR); Pain scale measurement; Erythema score; Satisfaction with treatment outcome from the technique; Satisfaction with cosmetic outcome from the technique Case Comprehensive Cancer Center All Child, Adult, Older Adult 37 Other Interventional Study Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment CASE5617 10/01/2018 06/01/2023 30/11/2023 16/03/2018 30/03/2023 https://ClinicalTrials.gov/show/NCT03467789 Localised/Locoregional Hospital/University/Research Institute Y N N United States Skin Basal Cell Carcinoma Calcipotriol; Calcitriol; Cholecalciferol; Paricalcitol Response rate Other DB00136; DB08907; Not found in DrugBank; DB00715 N
NCT02518555 Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Active, not recruiting Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Biological: Pneumococcal 13-valent Conjugate Vaccine; Other: Quality-of-Life Assessment; Biological: Trivalent Influenza Vaccine Proportion of patients who are alive and progression-free; Degree of response (CR MRD-,CR, PR, PR with lymphocytosis, and SD); Incidence of adverse events, evaluated using the NCI CTCAE version 4.0; Proportion of patients who achieve complete response; Time to next treatment; Time to treatment failure Jennifer Woyach; Pharmacyclics LLC.; Ohio State University Comprehensive Cancer Center All 18 Years and older (Adult, Older Adult) 42 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OSU-15012; NCI-2015-00932 01/12/2016 31/12/2023 31/12/2023 08/10/2015 04/03/2023 https://ClinicalTrials.gov/show/NCT02518555 Localised/Locoregional Hospital/University/Research Institute N Y N United States Leukemia; Lymphoma Chronic Lymphocytic Leukemia; Lymphoma - Other Diphtheria vaccine; Pertussis vaccine; Tetanus vaccine Safety and/or Dose; Response rate; PFS Phase 2 DB00975; DB00780; DB00730 N
NCT03323346 Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer DISC Recruiting Breast Neoplasm Female|Metastatic Breast Cancer Drug: Disulfiram Clinical response rate (RR); Clinical benefit rate (CBR); Time to progression (TTP); Overall survival (OS); The pharmacokinetic (PK) characteristics; The pharmacokinetic (PK) characteristic - Area Under Curve (AUC); The pharmacokinetic (PK) characteristic - T-max; The pharmacokinetic (PK) characteristic - T1/2; The pharmacokinetic (PK) characteristic - z; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 The Institute of Molecular and Translational Medicine, Czech Republic; University Hospital Olomouc Female 18 Years and older (Adult, Older Adult) 150 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2016-1-DSF-MBC 29/09/2017 31/12/2023 31/12/2023 27/10/2017 03/08/2023 https://ClinicalTrials.gov/show/NCT03323346 Advanced/Metastatic Hospital/University/Research Institute N N N Czech Republic Breast Any Breast Cancer Disulfiram Response rate Phase 2 DB00843 N
NCT04301843 Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Recruiting Neuroblastoma Drug: Eflornithine Number of participants with event free survival (EFS) during study; Length of time that participants experience Overall Survival (OS); Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria.; Number of Participants with Adverse Events as a Measure of Safety and Tolerability Wake Forest University Health Sciences; K C Pharmaceuticals Inc.; Beat NB Cancer Foundation; Team Parker for Life All up to 31 Years (Child, Adult) 131 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BCC015 25/09/2020 10/01/2025 10/01/2030 03/10/2020 05/08/2023 https://ClinicalTrials.gov/show/NCT04301843 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Other Neuroblastoma Eflornithine DFS/RFS/EFS Phase 2 DB06210 N
NCT02395666 Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission Active, not recruiting Neuroblastoma Drug: DFMO Number of Participants With Event Free Survival (EFS) During Study.; Percentage of Participants With Overall Survival (OS); Number of Participants With Adverse Events as a Measure of Safety and Tolerability; Test the Association of Survival With ODC1 Genotype; Circulating Tumor Cell Analysis; Peak Plasma Concentration (Cmax); Area Under the Plasma Concentration Versus Time Curve (AUC); Time to Reach Peak Plasma Concentration (Tmax) Wake Forest University Health Sciences; Beat NB Cancer Foundation; Because of Ezra; K C Pharmaceuticals Inc. All up to 21 Years (Child, Adult) 140 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention NMTRC003B 03/05/2015 03/01/2018 30/04/2023 23/03/2015 04/03/2020 04/06/2023 https://ClinicalTrials.gov/show/NCT02395666 Localised/Locoregional Hospital/University/Research Institute N N Y United States Other Neuroblastoma Eflornithine DFS/RFS/EFS Phase 2 DB06210 N
NCT03794349 Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma Recruiting High Risk Neuroblastoma|Recurrent Neuroblastoma|Refractory Neuroblastoma Biological: Dinutuximab; Drug: Eflornithine Hydrochloride; Drug: Irinotecan Hydrochloride; Biological: Sargramostim; Drug: Temozolomide Response rate; Progression-free survival (PFS); Overall survival (OS); Incidence of adverse events >= Grade 3 (Regimen B) Children's Oncology Group; National Cancer Institute (NCI) All 1 Year and older (Child, Adult, Older Adult) 95 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ANBL1821; NCI-2018-03377; U10CA180886 28/05/2019 30/06/2024 30/06/2024 01/07/2019 23/05/2023 https://ClinicalTrials.gov/show/NCT03794349 Recurrent/Refractory Collaborative Group Y N Y United States Other Neuroblastoma Eflornithine Response rate Phase 2 DB06210 N
NCT05634707 Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT) Not yet recruiting Primary Brain Tumor|Brain Tumor, Recurrent Drug: Fluoxetine; Drug: Temozolomide Change in LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery; Proportion of patients with partial or complete response at the time of surgical resection; Serum levels of fluoxetine using LC-MS/MS quantification; Serum levels of norfluoxetine using LC-MS/MS quantification; Intra-tumoral levels of fluoxetine using LC-MS/MS quantification; Intra-tumoral levels of norfluoxetine using LC-MS/MS quantification Duke University All 24 Years and older (Adult, Older Adult) 30 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Pro00110628 15/05/2023 12/01/2023 06/01/2024 12/02/2022 04/12/2023 https://ClinicalTrials.gov/show/NCT05634707 Any/All Stages Hospital/University/Research Institute Y N N United States CNS Glioma Fluoxetine Biomarker Phase 1 DB00623 N
NCT02935205 Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer Recruiting Metastatic Prostate Carcinoma|Recurrent Prostate Carcinoma|Stage IV Prostate Cancer Drug: Enzalutamide; Drug: Indomethacin Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0; PSA response rate defined as >= 50 decrease from the baseline; Overall response determined by PCWG2 criteria; Overall survival; PFS Mamta Parikh; National Cancer Institute (NCI); University of California, Davis Male 19 Years and older (Adult, Older Adult) 38 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 949968; UCDCC#267; P30CA093373; NCI-2016-01479 17/01/2017 07/01/2023 02/01/2024 17/10/2016 26/04/2023 https://ClinicalTrials.gov/show/NCT02935205 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Prostate Cancer Indomethacin Safety and/or Dose; Biomarker Phase 1/2 Not found in DrugBank N
NCT02429570 Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary Active, not recruiting Recurrent Brain Metastases|Progressive Brain Metastases Drug: Meclofenamate Feasible (if at least 50 of patients enrolled are evaluable in brain by MRI at the 2-month timepoint); Adverse events; Progression free survival Memorial Sloan Kettering Cancer Center All 18 Years to 80 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 15-068 22/04/2015 04/01/2024 04/01/2024 29/04/2015 05/03/2023 https://ClinicalTrials.gov/show/NCT02429570 Advanced/Metastatic Hospital/University/Research Institute N N N United States CNS Other CNS Meclofenamate Other (specify) Other DB00784 N
NCT04844528 Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC) Recruiting Chronic Lymphocytic Leukemia Drug: Nicotinamide; Drug: Placebo Proportion of CLL patients who develop a new NMSC after 1 year of nicotinamide therapy.; Number of new NMSC on skin exam after 1 year of treatment; proportion of CLL patients who develop squamous cell carcinoma (SCC) on skin exam after 1 and 2 years of treatment.; proportion of CLL patients who develop basal cell carcinoma (BCC) on skin exam after 1 and 2 years of treatment.; proportion of CLL patients who develop actinic keratosis (AK) on skin exam after 1 and 2 years of treatment.; number of new NMSC developed during year 1 and year 2 for patients who receive placebo during the first year; objective response rate (the proportion of subjects achieving a complete response [CR] or partial response [PR]) and complete response rate as calculated per International Workshop on CLL (IWCLL) 2018 Criteria at Month 6, 12, 18, and 24; objective response rate (the proportion of subjects achieving a CR or PR) and complete response rate as calculated per International Workshop on CLL (IWCLL) 2018 Criteria at Month 6, 12, 18, and 24; frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0 and iwCLL), seriousness, duration, and relationship to study treatment University of Utah All 18 Years and older (Adult, Older Adult) 86 Other Interventional Study Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment HCI141430 08/05/2021 08/01/2024 08/01/2026 14/04/2021 03/10/2023 https://ClinicalTrials.gov/show/NCT04844528 Localised/Locoregional Hospital/University/Research Institute Y N N United States Leukemia Chronic Lymphocytic Leukemia Nicotinamide Recurrence rate Phase 2 DB01115 N
NCT04677049 Study of Niacin in Glioblastoma Recruiting Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype Drug: Niacin CRT Determining the Maximum Tolerated Dose; Evaluating if Niacin CRT Improves Glioblastoma Survival Rates; Effect of Niacin CRT in Peripheral Monocytes; Response Rate Associated with Niacin; Overall Survival Rate Associated with Niacin; Quality of Life While on Study using EORTC QLQ-C30 Questionnaires; Quality of Life While on Study using EORTC BN-20 Questionnaires AHS Cancer Control Alberta; Tom Baker Cancer Centre All 18 Years to 75 Years (Adult, Older Adult) 59 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NiacinCNS2020 18/03/2021 01/01/2026 01/01/2026 21/12/2020 23/03/2023 https://ClinicalTrials.gov/show/NCT04677049 Localised/Locoregional Hospital/University/Research Institute N N N Canada CNS Glioblastoma Nicotinamide Safety and/or Dose; PFS Phase 1/2 DB01115 N
NCT02295059 Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention Active, not recruiting Breast Cancer Dietary Supplement: omega 3 fatty acids Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue; Changes in cytomorphology and/or cell proliferation of mammary epithelial cells; Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue City of Hope Medical Center; National Cancer Institute (NCI) Female 18 Years and older (Adult, Older Adult) 80 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention 16421; 1R01CA164019-01A1 08/09/2017 30/12/2023 30/12/2023 20/11/2014 22/02/2023 https://ClinicalTrials.gov/show/NCT02295059 Localised/Locoregional Hospital/University/Research Institute N Y N United States Breast Breast Cancer - ER/HR- Omega 3 Biomarker Other DB00338 N
NCT03138720 Pre-operative Treatment for Patients With Untreated Pancreatic Cancer Active, not recruiting Resectable Pancreatic Cancer|Unresectable Pancreatic Cancer|Pancreatic Adenocarcinoma|Neoadjuvant Pancreatic Cancer Drug: Paclitaxel Protein Bound (Abraxane) CA19-9 value; Pathologic Complete Response Rate; Overall Survival HonorHealth Research Institute All 18 Years and older (Adult, Older Adult) 24 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NABPLAGEM-NEO 2017-001 23/05/2017 31/12/2023 07/01/2024 05/03/2017 18/04/2023 https://ClinicalTrials.gov/show/NCT03138720 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Paricalcitol Response rate; OS; Biomarker Phase 2 DB00715 N
NCT03415854 Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD) NABPLAGEMD Active, not recruiting Pancreatic Cancer|Pancreatic Ductal Adenocarcinoma|Pancreatic Adenocarcinoma|Pancreas Metastases|Adenocarcinoma Drug: Paricalcitol (Zemplar) Pathologic Complete Response Rate; Carbohydrate Antigen 19-9 (CA19-9) value; changes in circulating biomarkers induced by paricalcitol; changes in circulating biomarkers induced by chemotherapy; pharmacodynamics effect of Paricalcitol; Parathyroid Hormone (PTH); Vitamin D 25-hydroxy (OH) HonorHealth Research Institute; Barts Cancer Institute; Abramson Cancer Center at Penn Medicine; Salk Institute for Biological Studies; Mayo Clinic; Princeton University; Imaging Endpoints; Translational Genomics Research Institute; Stand Up To Cancer; Cancer Research UK; Lustgarten Foundation; University of California, San Diego All 18 Years and older (Adult, Older Adult) 14 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SU2C HRI NPG-001 31/01/2018 31/12/2023 31/01/2024 30/01/2018 13/04/2023 https://ClinicalTrials.gov/show/NCT03415854 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Paricalcitol Response rate; Biomarker Phase 2 DB00715 N
NCT02754726 Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Active, not recruiting Untreated Metastatic Pancreatic Ductal Adenocarcinoma Drug: Nivolumab; Drug: Albumin-bound paclitaxel; Drug: Paricalcitol; Drug: Cisplatin; Drug: Gemcitabine Complete response rate; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 HonorHealth Research Institute; Translational Genomics Research Institute; Bristol-Myers Squibb; Lustgarten Foundation All 18 Years and older (Adult, Older Adult) 10 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NAPPCG-EB 2015-001 04/01/2016 30/06/2023 12/01/2023 28/04/2016 13/04/2023 https://ClinicalTrials.gov/show/NCT02754726 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Paricalcitol Safety and/or Dose; Response rate Phase 2 DB00715 N
NCT03746080 Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma Recruiting Glioblastoma|Glioblastoma With Primitive Neuronal Component|Gliosarcoma|Malignant Glioma|Oligodendroglial Component Present Drug: Plerixafor; Drug: Temozolomide; Radiation: Whole-Brain Radiotherapy (WBRT); Radiation: Radiation Therapy Progression-free survival (PFS) at six months; Median Survival; Toxicity associated with Plerixafor/WBRT; Patterns of treatment failure Lawrence D Recht; Sanofi; Stanford University All 18 Years to 75 Years (Adult, Older Adult) 20 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB-46410; NCI-2018-02159; BRN0037 12/04/2018 26/01/2024 07/01/2027 19/11/2018 14/04/2023 https://ClinicalTrials.gov/show/NCT03746080 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma Plerixafor Safety and/or Dose; PFS; OS Phase 2 Not found in DrugBank N
NCT04310176 Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer REVOLUTION Recruiting Ras-mutated Metastatic Colorectal Cancer Drug: Bevacizumab; Drug: mFOLFOX6 regimen; Drug: mOXXEL regimen; Drug: Valproic acid; Drug: Capecitabine; Drug: 5-fluorouracil progression-free survival (PFS); centrally reviewed PFS (CR-PFS); overall survival (OS); Determination of changes in quality of life; Response rate; Number of participants with treatment-related side effects; metastases resection rate (R0/R1/R2) National Cancer Institute, Naples All 18 Years and older (Adult, Older Adult) 200 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment REVOLUTION; 2018-001414-15 24/05/2019 06/01/2023 11/01/2024 17/03/2020 27/03/2023 https://ClinicalTrials.gov/show/NCT04310176 Advanced/Metastatic Hospital/University/Research Institute N N N Italy GI Colon Cancer; Rectal Cancer Valproic Acid Safety and/or Dose; Response rate; PFS; OS; QoL Phase 2 DB00177 N
NCT01898104 Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer V-shoRT-R3 Recruiting Colorectal Cancer Radiation: preoperative radiation therapy; Drug: Valproic Acid; Drug: Capecitabine maximum tolerated dose of capecitabine, given alone or in combination with valproic acid; number of patients with complete pathological tumor regression; overall survival; number of patients alive with disease progression; number of patients with pathologic complete response; changes in quality of life from baseline National Cancer Institute, Naples All 18 Years to 70 Years (Adult, Older Adult) 152 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment V-shoRT-R3; 2012-002831-28 05/01/2012 11/01/2023 04/01/2024 07/12/2013 24/03/2023 https://ClinicalTrials.gov/show/NCT01898104 Localised/Locoregional Hospital/University/Research Institute Y Y N Italy GI Rectal Cancer Valproic Acid Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00177 N
NCT01953900 iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma VEGAS Active, not recruiting Osteosarcoma|Neuroblastoma Genetic: GD2 T cells; Biological: VZV vaccine; Drug: Fludarabine; Drug: Cyclophosphamide Number of patients with dose limiting toxicity; Amount of T cells in the blood after the infusions; Number of patients with a response to the T cells Baylor College of Medicine; National Cancer Institute (NCI); Center for Cell and Gene Therapy, Baylor College of Medicine; The Methodist Hospital Research Institute All Child, Adult, Older Adult 26 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H-32335 VEGAS; VEGAS; P01CA094237 04/01/2014 31/10/2019 31/10/2034 10/01/2013 30/03/2023 https://ClinicalTrials.gov/show/NCT01953900 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Other; Soft Tissue Sarcoma Any soft tissue sarcoma Varicella vaccine Safety and/or Dose Phase 1 DB00661 N
NCT03664687 Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL) REaCT-ZOL Active, not recruiting Early-stage Breast Cancer Drug: Zoledronate Multiple Site Activation; Time to Activate Six Sites; Medical Oncologist Active Participation; Patient Enrollment; Bone-Metastasis-Free Survival; Time to first bone metastasis; Fragility fractures rates; Direct Estimation of Health Utility Values; Incremental Cost-Effectiveness Ratio Ottawa Hospital Research Institute All 18 Years and older (Adult, Older Adult) 211 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OTT 18-01 31/10/2018 04/02/2020 12/01/2024 09/10/2018 05/11/2023 https://ClinicalTrials.gov/show/NCT03664687 Localised/Locoregional Hospital/University/Research Institute N N N Canada Breast Any Breast Cancer Zoledronic Acid DFS/RFS/EFS; Other (specify) Phase 4 N
NCT03173976 Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial Recruiting Chondrosarcoma Drug: Zoledronic Acid Phase 1b cohort: Dose Limiting Toxicity - to examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients; Expansion cohort: Response Rate - Change at evaluations; Recurrence (local or metastatic) free survival; Overall survival Varun Monga, MD; Rising Tide Foundation; University of Iowa All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 201610743 18/07/2017 07/01/2023 07/01/2023 06/02/2017 16/02/2023 https://ClinicalTrials.gov/show/NCT03173976 Localised/Locoregional Hospital/University/Research Institute N N N United States Bone Sarcoma Chondrosarcoma Zoledronic Acid Safety and/or Dose; OS; DFS/RFS/EFS Phase 1 N
NCT02301286 A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients ASPIRIN Active, not recruiting Colon Cancer|Adjuvant Therapy Drug: Acetylsalicylic acid; Drug: Placebo Acetylsalicylic acid 5 year overall survival; Disease Free Survival; Time to Treatment Failure Leiden University; Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS); Dutch Colorectal Cancer Group; Stichting Geriatrische Oncologie Nederland (GeriOnNe); Fonds NutsOhra; Innovatiefonds Zorgverzekeraars; Leiden University Medical Center All 45 Years and older (Adult, Older Adult) 770 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment P14.152 01/01/2015 12/01/2023 12/01/2023 25/11/2014 13/03/2023 https://ClinicalTrials.gov/show/NCT02301286 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands GI Colon Cancer Acetylsalicylic Acid OS; DFS/RFS/EFS Phase 3 DB01048 N
NCT05080946 Using Aspirin to Improve Immunological Features of Ovarian Tumors Recruiting Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer Drug: Aspirin 325mg; Drug: Placebo Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery; Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery; Change in density of tumor COX1; Change in density of tumor COX2; Change in blood levels of IL-6; Change in blood levels of p-selectin; Change in blood levels of CA 125; Change in tumor burden as defined by RECIST 1.1 H. Lee Moffitt Cancer Center and Research Institute; United States Department of Defense; Sharp Clinical Services, Inc Female 18 Years and older (Adult, Older Adult) 100 Other; U.S. Fed Interventional Study Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment MCC-20870; E01775.1a 11/02/2021 03/01/2025 03/01/2025 18/10/2021 04/12/2023 https://ClinicalTrials.gov/show/NCT05080946 Localised/Locoregional Hospital/University/Research Institute Y N N United States Gynaecological Fallopian Tube Cancer; Ovarian Epithelial Cancer; Primary Peritoneal Cancer; Ovarian Germ Cell Tumor; Ovarian - Other Acetylsalicylic Acid Biomarker Phase 1 DB01048 N
NCT05462613 Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer REPROGRAM-02 Recruiting Metastatic Colorectal Cancer Other: quality of life questionnaires; Procedure: Blood sample; Drug: Regorafenib; Drug: Metronomic chemotherapies; Drug: Aspirin; Drug: Bevacizumab; Drug: FOLFIRI or FOLFOX best objective response during treatment period (phase II); overall survival (OS) (phase III) Centre Hospitalier Universitaire de Besancon All 18 Years and older (Adult, Older Adult) 446 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2022/702 05/09/2023 11/01/2029 11/01/2030 18/07/2022 26/05/2023 https://ClinicalTrials.gov/show/NCT05462613 Advanced/Metastatic Hospital/University/Research Institute Y N N France GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Response rate; OS Phase 2/3 DB01048 N
NCT04900792 A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma XACT-Fe-GBM-01 Suspended Glioblastoma|Glioblastoma Multiforme Drug: Ferumoxytol injection; Drug: Pharmacological ascorbate; Radiation: External beam radiation therapy; Drug: Temozolomide Determination of recommended phase 2 ferumoxytol dosing regimen; Estimate progression free survival (PFS); Estimate overall survival (OS); Estimate Objective Response Rate (ORR); Tumor size; Clinical response; Number of Treatment-Related Adverse Events Bryan Allen; Holden Comprehensive Cancer Center; National Cancer Institute (NCI); University of Iowa All 18 Years and older (Adult, Older Adult) 12 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 202103125 28/02/2023 30/06/2024 31/12/2025 25/05/2021 20/04/2023 https://ClinicalTrials.gov/show/NCT04900792 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS DIPG/DMG; Glioblastoma Ascorbic acid Safety and/or Dose; PFS; OS Phase 1 DB00335 N
NCT03299309 PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma PRiME Active, not recruiting Recurrent Medulloblastoma|Recurrent Brain Tumor, Childhood|Malignant Glioma Drug: PEP-CMV Proportion of patients with unacceptable toxicity; Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN- ); Mean or median change from baseline at each follow-up assessment in ELISA (gB-KLH) Daniel Landi; Pediatric Brain Tumor Foundation; Annias Immunotherapeutics, Inc.; Duke University All 3 Years to 35 Years (Child, Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Pro00079843 29/06/2018 27/04/2023 04/01/2025 10/03/2017 18/05/2023 https://ClinicalTrials.gov/show/NCT03299309 Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS Medulloblastoma; Glioma Diphtheria vaccine; Tetanus vaccine Safety and/or Dose Phase 1 DB00975; DB00730 N
NCT05096481 PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma Not yet recruiting High Grade Glioma|Diffuse Intrinsic Pontine Glioma|Recurrent Medulloblastoma Biological: PEP-CMV; Drug: Temozolomide; Biological: Tetanus Diphtheria Vaccine 4-mo PFS in patients with recurrent medulloblastoma; 1-yr OS in patients with newly diagnosed DIPG; 1-yr PFS in patients with newly diagnosed HGG; ORR in patients with recurrent medulloblastoma; PFS in patients with recurrent medulloblastoma; OS in patients with newly diagnosed HGG by PEP-CMV Nationwide Children's Hospital All 3 Years to 25 Years (Child, Adult) 120 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CONNECT1906; R01FD007283 15/05/2023 15/05/2027 15/05/2029 27/10/2021 21/02/2023 https://ClinicalTrials.gov/show/NCT05096481 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS DIPG/DMG; Medulloblastoma; Glioblastoma Diphtheria vaccine; Tetanus vaccine Response rate; PFS; OS Phase 2 DB00975; DB00730 N
NCT03688178 DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab DERIVe Recruiting Glioblastoma Biological: Human CMV pp65-LAMP mRNA-pulsed autologous DCs; Drug: Temozolomide; Biological: Varlilumab; Biological: Td; Biological: Unpulsed DCs Median Overall Survival (OS) of Subjects Receiving Td pre-conditioning; Safety of administering Varlilumab to GBM patients receiving temozolomide and dendritic cell vaccines Td pre-conditioning as measured by the percentage of patients with unacceptable toxicity regardless of attribution; Median percent change between baseline, assessed on day 14, and nadir levels of Treg before the time that the second cycle of adjuvant TMZ would be administered. Treg determined by flow cytometry (CD3+ CD4+ CD25+ Foxp3+).; Median Overall Survival (OS) of Subjects Receiving DC vaccines, varlilumab, and Td pre-conditioning; Median Progression-free Survival (PFS); Median Chemokine (C-C motif) ligand 3 (CCL3) Levels in Serum at 24, 48, and 72 hours after Pre-conditioning Annick Desjardins, MD; Celldex Therapeutics; Duke University All 18 Years and older (Adult, Older Adult) 80 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment Pro00082570 26/08/2020 03/01/2025 03/01/2025 28/09/2018 03/02/2023 https://ClinicalTrials.gov/show/NCT03688178 Localised/Locoregional Hospital/University/Research Institute N Y N United States CNS Glioblastoma Diphtheria vaccine; Tetanus vaccine Safety and/or Dose; OS Phase 2 DB00975; DB00730 N
NCT05500508 Oral AMXT 1501 Dicaprate in Combination With IV DFMO Recruiting Cancer|Solid Tumor|Solid Carcinoma|Advanced Cancer|DIPG Brain Tumor|Ovary Cancer|Breast Cancer|Papillary Thyroid Cancer|Head and Neck Cancer|Gastric Cancer|Nsclc|Mesotheliomas Pleural|Mesothelioma Peritoneum|Esophageal Cancer|Diffuse Midline Glioma, H3 K27M-Mutant|Endometrial Cancer|Cervical Cancer|Melanoma|Colorectal Cancer|Glioma, Malignant Drug: AMXT1501; Drug: DFMO Determine DLTs and RP2Ds in AMXT 1501 in combination with IV DFMO; Determine safety and tolerability of AMXT1501 in combination with IV DFMO; Determine the PK using AUC of AMXT 1501 and IV DFMO; Determine the PK using Cmax of AMXT 1501 and IV DFMO; Characterize investigator defined response Overall Response Rate (ORR) using RECIST v1.1; Characterize investigator defined Duration of Response (DOR); Characterize AMXT1501 and IV DFMO on the expression of immune related gene signatures Aminex Therapeutics, Inc. All 12 Years and older (Child, Adult, Older Adult) 56 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AMXT1501-102 29/11/2022 30/12/2023 31/03/2024 15/08/2022 25/05/2023 https://ClinicalTrials.gov/show/NCT05500508 Advanced/Metastatic; Recurrent/Refractory Company N N Y United States Multiple cancer types Any solid tumours Eflornithine Safety and/or Dose Phase 1/2 DB06210 N
NCT05717153 Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma Recruiting Diffuse Glioma|Malignant Glioma Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Eflornithine; Procedure: Magnetic Resonance Imaging; Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate; Procedure: Resection; Device: Post-operative Microdialysis Change in the tumor/brain extracellular guanidinoacetate ratio; Measured extracellular levels of glutamate in tumor and brain microdialysates; Proportion of longitudinal microdialysis aliquots containing > 30 uL of microdialysate; Central nervous system free drug levels from microdialysate; AMXT1501 brain/plasma ratio over time; Incidence of adverse events Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 15 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Basic Science 22-005690; NCI-2022-10375; P30CA015083 03/01/2023 15/01/2025 15/01/2026 02/08/2023 03/03/2023 https://ClinicalTrials.gov/show/NCT05717153 Localised/Locoregional Hospital/University/Research Institute Y N N United States CNS Glioma; DIPG/DMG Eflornithine Safety and/or Dose; Biomarker Phase 1 DB06210 N
NCT04432597 HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers Active, not recruiting HPV Positive Cancer|Vulvar, Vaginal, Penile, Rectal Cancer|Anal Cancer|Oropharyngeal Cancer|Cervical Cancer Biological: PRGN-2009; Biological: M7824 Safety and recommended phase II dose of PRGN-2009; Level increase in CD3+ tumor infiltrating T cells post-treatment compared to pre-treatment; ratio of participants that are hospitalized because of adverse events attributed to disease progression; 3-year overall and relapse-free survival rate for PRGN-2009 alone; overall survival (OS); progression-free survival time (PFS); duration of response; assess the safety of the recommended phase II dose (RP2D) of PRGN-2009 (HPV vaccine) alone; does the use of PRGN-2009 alone result in significantly prolonged survival; overall response rate (ORR) National Cancer Institute (NCI); National Institutes of Health Clinical Center (CC) All 18 Years and older (Adult, Older Adult) 20 NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 200104; 20-C-0104 08/11/2020 22/11/2022 10/01/2023 16/06/2020 25/04/2023 https://ClinicalTrials.gov/show/NCT04432597 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Other multiple cancer group (specify) HPV vaccine Safety and/or Dose; PFS; OS; Biomarker Phase 1/2 DB01275 N
NCT03253289 Meclizine for Hepatocellular Carcinoma OPTIM Active, not recruiting Carcinoma, Hepatocellular Drug: Meclizine Oral Tablet Change in mRNA levels; Change in Ki-67 proliferation index; change in apoptosis by TUNEL assay; Tumor response; Change in Serum AFP; Change in growth differentiation factor (GDF-15); A panel of CAR downstream target genes Tannaz Armaghnay; Baylor College of Medicine All 18 Years and older (Adult, Older Adult) 13 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H-40370 13/10/2017 12/01/2023 12/01/2026 17/08/2017 04/06/2023 https://ClinicalTrials.gov/show/NCT03253289 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Liver Cancer Meclizine Safety and/or Dose Phase 1 DB00939 N
NCT05607407 Methimazole in Patients With Progressive Glioblastoma Recruiting Glioblastoma|Glioma Drug: Methimazole; Procedure: Recurrent Glioblastoma Surgical Resection; Diagnostic Test: Pharmacodynamic Assays Progression Free Survival (PFS) Rate Case Comprehensive Cancer Center All 18 Years and older (Adult, Older Adult) 19 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CASE3322 30/04/2023 01/01/2025 01/01/2026 11/07/2022 04/06/2023 https://ClinicalTrials.gov/show/NCT05607407 Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioblastoma Methimazole PFS Phase 2 DB09241 N
NCT03942328 Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer Recruiting Stage III Hepatocellular Carcinoma AJCC v8|Stage III Intrahepatic Cholangiocarcinoma AJCC v8|Stage IV Hepatocellular Carcinoma AJCC v8|Stage IV Intrahepatic Cholangiocarcinoma AJCC v8|Unresectable Hepatocellular Carcinoma|Unresectable Intrahepatic Cholangiocarcinoma Biological: Atezolizumab; Biological: Bevacizumab; Radiation: External Beam Radiation Therapy; Procedure: Pheresis; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Therapeutic Autologous Dendritic Cells Incidence of significant toxicity (Pilot study); Progression-free survival rate at 2 years (Phase II); Overall response rate; Number of patients who received at least one dose of intratumoral DC injection; Clinical benefit rate; Time to response; Duration of response; Overall survival; Progression-free survival Mayo Clinic; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 54 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MC1641; NCI-2019-02452; P30CA015083; R01CA274985 06/11/2019 31/12/2026 31/12/2026 05/08/2019 19/05/2023 https://ClinicalTrials.gov/show/NCT03942328 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Liver Cancer Pneumococcal vaccine Safety and/or Dose; Response rate; PFS; OS Phase 1 DB01263 N
NCT05400603 Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed or Refractory Neuroblastoma Aflac-NBL-2002 Recruiting Neuroblastoma|Refractory Neuroblastoma|Relapsed Neuroblastoma Combination Product: Ex Vivo Expanded Allogeneic T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate Maximum Tolerated Dose/Recommended Phase 2 Dose of gamma delta T cells; Describe Non-Hematological Toxicities; Describe Hematological Toxicities; Overall Response Emory University All 12 Months to 16 Years (Child) 24 Other Interventional Study Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00003123 05/01/2023 12/01/2025 12/01/2025 06/01/2022 27/04/2023 https://ClinicalTrials.gov/show/NCT05400603 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Neuroblastoma Zoledronic Acid Safety and/or Dose Phase 1 N
NCT05865548 Addition of Aspirin to Standard of Care in Oral Cancer Recruiting Oral Cancer Drug: Aspirin 150 mg; Procedure: Standard of care Adverse events; Disease free survival; Overall survival Banaras Hindu University All 18 Years to 99 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HNC02 17/05/2023 30/09/2024 30/09/2024 19/05/2023 24/05/2023 https://ClinicalTrials.gov/show/NCT05865548 Any/All Stages Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Acetylsalicylic Acid Safety and/or Dose Phase 2/3 DB01048 N
NCT05849129 Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer AIVAA Not yet recruiting Lung Cancer Drug: Ascorbic acid; Other: Normal Saline Change in Quality of Life; Chemotherapy-Related Toxicities; Frequency of Discontinuation of Chemotherapy; Change in General Symptom Burden; Change in C-Reactive Protein Levels; Tumour Progression; Survival; Safety; Cytotoxicity The Canadian College of Naturopathic Medicine; Ottawa Hospital Research Institiute All 18 Years and older (Adult, Older Adult) 90 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care 20220721-01H 07/01/2023 07/01/2029 07/01/2030 05/08/2023 05/10/2023 https://ClinicalTrials.gov/show/NCT05849129 Advanced/Metastatic Hospital/University/Research Institute Y N N Canada Lung Non-Small Cell Lung Cancer Ascorbic acid QoL Phase 2 DB00335 N
NCT05846880 VitD3 Supplementation in Patients With Multiple Myeloma Not yet recruiting Multiple Myeloma Drug: Lenalidomide; Drug: Vitamin D - Intensified; Drug: Vitamin D - Therapeutic To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]; To report the 3-year progression-free survival for both treatment arms - intensified vs. therapeutic Vitamin D supplementation; To report the overall response rate for both treatment arms 120 days after ASCT for adult patients with multiple myeloma.; To report the overall response rate for both treatment arms 2 years after transplantation; To report the 3-year overall survival for the two treatment arms after transplantation.; To report the minimal residual disease status for the two treatment arms at randomization, and within 120 days after transplantation and 2 years after transplantation.; To report the vitamin D levels between the two treatments arms before autologous stem cell transplant, within 120 days, and 3-years post-transplantation; To describe the adverse events for the two treatment arms; To report time to neutrophil and platelet engraftment as well as transfusion independence after transplantation in both treatment arms Amany Keruakous, MD, MS.; Augusta University All 18 Years and older (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GCC-22-044 05/01/2023 05/01/2028 05/01/2028 05/06/2023 05/06/2023 https://ClinicalTrials.gov/show/NCT05846880 Localised/Locoregional Hospital/University/Research Institute Y N N United States Other Haem-onc Multiple Myeloma Cholecalciferol Other (specify) Phase 1 Not found in DrugBank N
NCT05879367 Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma Recruiting Glioblastoma, IDH-wildtype|Glioblastoma|Glioblastoma Multiforme|Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype|GBM Drug: Eflornithine (Dose Level 1); Drug: Eflornithine (Dose Level 2); Drug: Eflornithine (Dose Level -1); Drug: Temozolomide Assessment of Dose Limiting Toxicities; Incidence of TEAEs; Vital Signs (Heart and Respiratory Rate); Vital Signs (Blood Pressure); Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests; Progression Free Survival; Overall Response Rate; Pharmacokinetics Cmax; Pharmacokinetics Cmin; Pharmacokinetics Tmax; Pharmacokinetics AUCt; Pharmacokinetics lambdaz; Pharmacokinetics t 1/2 Orbus Therapeutics, Inc. All 18 Years and older (Adult, Older Adult) 60 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OT-21-101 26/05/2023 15/12/2024 15/12/2024 29/05/2023 29/05/2023 https://ClinicalTrials.gov/show/NCT05879367 Localised/Locoregional Company N Y N United States CNS Glioblastoma Eflornithine Safety and/or Dose Phase 1 DB06210 N
NCT05799144 pBI-11 TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS 1, hrHPV+ Oropharyngeal Cancer Recruiting Metastatic Oropharyngeal Carcinoma|Recurrent Oropharyngeal Carcinoma Biological: DNA Vaccine; Biological: Human Papillomavirus Tumor Antigen Vaccine; Biological: Pembrolizumab; Procedure: Computed Tomography (CT); Procedure: Magnetic Resonance Imaging (MRI); Procedure: Magnetic Resonance Imaging; Procedure: Biopsy Objective response rate (ORR); Disease control rate (DCR); Progression-free survival (PFS); Overall survival (OS) Michael K. Gibson; Vanderbilt-Ingram Cancer Center All 18 Years and older (Adult, Older Adult) 54 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VICCHN2208; NCI-2023-02083 31/05/2023 30/04/2027 30/04/2028 04/05/2023 05/10/2023 https://ClinicalTrials.gov/show/NCT05799144 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Head and Neck Oropharyngeal Cancer HPV vaccine Response rate Phase 2 DB01275 N
NCT05866172 HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC Recruiting Hepatocellular Carcinoma Procedure: HAIC; Drug: Zoledronic acid overall survival; Progression Free Survival (PFS); Objective Response Rate (ORR); Adverse Events Sun Yat-sen University All 18 Years to 75 Years (Adult, Older Adult) 264 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment S-069 05/10/2023 12/01/2024 06/01/2025 19/05/2023 19/05/2023 https://ClinicalTrials.gov/show/NCT05866172 Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Liver Cancer Zoledronic Acid OS Phase 3 N
NCT04926467 Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC) Not yet recruiting Pancreatic Adenocarcinoma Drug: Anakinra To determine the percentage of patients that have a normalization of CA19-9 after pre-op treatment with the combination of nab-paclitaxel (abraxane), gemcitabine, cisplatin and anakinra.; To determine the effect of anakinra in combination with perioperative chemotherapy on overall survival (OS) of PDAC patients. A benchmark of 24 months OS will be used to determine how many patients meet or exceed this goal.; To determine the effect of anakinra in combination with perioperative chemotherapy on the median disease free survival (DFS). A benchmark of 12 months DFS will be used to determine how many patients meet or exceed this goal.; To determine the effect of anakinra in combination with perioperative chemotherapy on response rate; To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.; To describe the effect of anakinra in combination with perioperative chemotherapy on the prevalence and severity of pain by monitoring patients' pain level using memorial pain assessment card (MPAC).; To determine the effect of anakinra in combination with perioperative chemotherapy on patients' health-related quality of life by monitoring patients using EORTC quality of life survey questionnaire (EORTC QLQ-C30).; To determine the effect of anakinra in combination with perioperative chemotherapy on the inflammasomes ( IL6, CRP, IL1 and IL1 ) in blood and in the resected pathology specimens. Baylor Research Institute All 18 Years and older (Adult, Older Adult) 24 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 020-476 06/01/2021 06/01/2025 06/01/2026 15/06/2021 15/06/2021 https://ClinicalTrials.gov/show/NCT04926467 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Anakinra PFS; OS; DFS/RFS/EFS Phase 2 DB00673 N
NCT02633098 A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer NeoART Recruiting Colorectal Cancer|Bowel Cancer Drug: Artesunate 200mg; Drug: Placebo Recurrence free survival at 2 years; Recurrence free survival at 5 years; Overall survival at 2 and 5 years; Colon cancer specific death at 2 and 5 years; Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0; Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0; Pathological assessment of tumour regression (involvement of lymph nodes; serosa; resection margin); Patient quality of life; Surgical complications; Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy; Immunohistochemical analyses of paraffin-embedded tumour sections to assess Kirsten rat sarcoma viral oncogene homolog (Kras) mutation status; Immunohistochemical analyses of paraffin-embedded tumour sections to assess Mismatch Repair (MMR) status; Immunohistochemical analyses of paraffin-embedded tumour for v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation status; Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor (PDGF) expression; Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor receptor (PDGFR) expression; Immunohistochemical analyses of paraffin-embedded tumour for Vascular endothelial Growth Factor (VEGF) expression; Immunohistochemical analyses of paraffin-embedded tumour on Vascular endothelial Growth Factor Receptor (VEGFR) expression; Determination of proliferative activity (Ki-67 staining, Cluster of Differentiation 31 protein (CD31) staining); Determination of activation of the Deoxyribonucleic acid damage response (DDR) pathway; Wnt/ -catenin proliferation pathway protein expression (e.g. c-myc and cyclinD1 proteins) St George's, University of London All 18 Years and older (Adult, Older Adult) 200 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 15.0154 26/04/2017 31/12/2022 31/10/2025 17/12/2015 10/12/2022 https://ClinicalTrials.gov/show/NCT02633098 Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom GI Colon Cancer; Rectal Cancer Artesunate Safety and/or Dose; OS; DFS/RFS/EFS Phase 2 DB00126 N
NCT05507398 The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer Not yet recruiting Breast Cancer Female Drug: Placebo, metformin and atorvastatin Improvement in the overall response rate; Improvement in the pathological response Tanta University Female 18 Years and older (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment Breast cancer treatment 10/01/2022 07/01/2023 09/01/2023 19/08/2022 31/10/2022 https://ClinicalTrials.gov/show/NCT05507398 Localised/Locoregional Hospital/University/Research Institute Y Y N Egypt Breast Any Breast Cancer Atorvastatin; Metformin Response rate Phase 4 DB01117; DB00703 N
NCT04601116 The MASTER Study (MAmmary Cancer STatin ER Positive Study) Recruiting Breast Cancer Female|Estrogen Receptor Positive Tumor Drug: Atorvastatin 80 Mg Oral Tablet; Drug: Placebo oral tablet Invasive disease-free survival; Distant-recurrence free interval; Recurrence-free interval; Overall survival.; Incidence of Treatment-Emergent Adverse Events as assessed by CTC-AE, 5.0; Cardiac death-free interval; Co-morbidity Aarhus University Hospital; Rigshospitalet, Denmark; Hospital of Southern Jutland; University of Copenhagen; Bornholms Hospital; Naestved Hospital; Vejle Hospital; Odense University Hospital; Nordsjaellands Hospital; Aalborg University Hospital; Herning Hospital Female 18 Years and older (Adult, Older Adult) 3360 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment SBMASTER; 2019-002508-42 01/04/2021 01/01/2025 01/01/2035 23/10/2020 14/01/2021 https://ClinicalTrials.gov/show/NCT04601116 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Denmark Breast Breast Cancer - ER/HR+ Atorvastatin DFS/RFS/EFS Phase 3 DB01117 N
NCT02958852 A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer ABC-SE Recruiting Breast Cancer Drug: Letrozole; Drug: Letrozole and atorvastatin; Drug: Fulvestrant Clinical benefit rate.; Progression free survival.; Objective response rate.; Time to progression.; Duration of Clinical benefit.; Overall survival.; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Lund University Hospital; South Sweden Breast Cancer Group Female 18 Years and older (Adult, Older Adult) 126 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OKFE 15-ABC-SE 11/01/2016 04/01/2024 04/01/2024 11/08/2016 09/02/2020 https://ClinicalTrials.gov/show/NCT02958852 Advanced/Metastatic Hospital/University/Research Institute Y N N Sweden Breast Breast Cancer - ER/HR+ Atorvastatin Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 2 DB01117 N
NCT05103644 Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients Recruiting Breast Cancer Drug: Atorvastatin 80mg; Other: placebo Ki-67 molecular; TAZ (WWTR1) TAZ expression; cardiac markers; Overall survival OS; Overall response rate Beni-Suef University Female 18 Years to 80 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention FMBSUREC/10102021/Rabie 30/10/2021 30/12/2023 30/12/2024 11/02/2021 11/02/2022 https://ClinicalTrials.gov/show/NCT05103644 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Breast Cancer - HER2- Atorvastatin Response rate; OS; Biomarker Phase 2/3 DB01117 N
NCT03819101 Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer PEACE-4 Recruiting Prostate Cancer Drug: Acetylsalicylic acid; Drug: Atorvastatin Overall Survival (OS) Gustave Roussy, Cancer Campus, Grand Paris; National Cancer Institute, France Male 18 Years and older (Adult, Older Adult) 1210 Other Interventional Study Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2017-004639-35; 2017/2601 06/06/2019 03/01/2034 03/01/2038 28/01/2019 14/02/2023 https://ClinicalTrials.gov/show/NCT03819101 Palliative Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N France Urological Prostate Cancer Acetylsalicylic Acid; Atorvastatin OS Phase 3 DB01048; DB01117 N
NCT03971019 Survival Benefits of Statins in Breast Cancer Patients SBSBC Recruiting Breast Cancer Female Drug: statins; Behavioral: Dietary intervention group (control group) DFS; OS Peking Union Medical College Hospital Female 18 Years to 75 Years (Adult, Older Adult) 314 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PUMCH-SBSBC 28/03/2019 28/05/2024 28/06/2024 06/03/2019 14/08/2019 https://ClinicalTrials.gov/show/NCT03971019 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Atorvastatin; Simvastatin DFS/RFS/EFS Phase 3 DB01117; DB00877 N
NCT04862260 Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma Recruiting Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer|Pancreas Cancer|Metastatic Cancer Drug: Cholesterol metabolism disruption Safety as measured by the rate of adverse events; Characterization of dose-limiting toxicities; LDLR (low-density lipoprotein receptor) tumoral and hepatic changes in response to the multipathway cholesterol embargo.; LRP1 (Low-density lipoprotein Receptor-Related Protein 1) tumoral and hepatic changes in response to the multipathway cholesterol embargo.; NPC1L1 (Niemann-Pick C1-Like 1 protein) tumoral and hepatic changes in response to the multipathway cholesterol embargo.; SRB1 (Scavenger Receptor class B type 1) tumoral and hepatic changes in response to the multipathway cholesterol embargo.; MHC-1 (Major Histocompatibility Complex class 1) tumoral and hepatic changes in response to the multipathway cholesterol embargo.; PD-L1 (Programmed Death-Ligand-1) changes in response to the multipathway cholesterol embargo.; Change in tumoral and hepatic levels of TILs (Tumor-Infiltrating Lymphocytes); CD36 (Cluster of Differentiation 36) changes in response to the multipathway cholesterol embargo CHU de Quebec-Universite Laval; Canadian Institutes of Health Research (CIHR); Biovalorem All 18 Years to 99 Years (Adult, Older Adult) 12 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CHLOE pancreas 10/04/2021 31/01/2025 31/12/2026 27/04/2021 23/08/2023 https://ClinicalTrials.gov/show/NCT04862260 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Pancreatic Cancer Atorvastatin Safety and/or Dose; Biomarker Phase 1 DB01117 N
NCT05796973 Measuring Oncological Value of Exercise and Statin MOVES Recruiting Prostate Cancer|Breast Cancer|Kidney Cancer|Ovarian Cancer|Metastatic Breast Cancer|Metastatic Kidney Cancer|Metastatic Renal Cell Carcinoma|Metastatic Renal Cancer|Metastatic Prostate Cancer|Metastatic Prostate Adenocarcinoma|Metastatic Ovarian Cancer|Metastatic Ovary Cancer Behavioral: Guided physical exercise; Drug: Atorvastatin; Other: Independent exercise Time to cancer progression; Mortality; Hypoxia markers in serum (VEGF, HIF1-alpha, carboanhydrase IX, LADH); Tolerability of treatment; Fat/muscle ratio as measured with impedance test; Physical performance with standardized muscle strength tests; Changes in tissue hypoxia; Changes in quality of life; Depressive symptoms; Severity of pain; Nutritional status; Relationship satisfaction Tampere University Hospital; Tampere University; Aalto University; University of Helsinki; University of Turku All 18 Years to 99 Years (Adult, Older Adult) 240 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019-001982-34 31/03/2023 31/12/2025 31/12/2027 04/04/2023 24/05/2023 https://ClinicalTrials.gov/show/NCT05796973 Primary/Main Curative; Palliative Advanced/Metastatic Hospital/University/Research Institute Y Y N Finland Gynaecological; Breast; Urological Ovarian Epithelial Cancer; Prostate Cancer; Any Breast Cancer; Renal Cell Carcinoma Atorvastatin PFS; OS Phase 3 DB01117 N
NCT05675787 Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia Recruiting Atypical Endometrial Hyperplasia|Endometrial Carcinoma Stage I Drug: Medroxyprogesterone acetate + Atorvastatin Pathological cumulative complete response rate;; The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue; Overall complete response rate; Pathological response rate classified by different blood lipid level; Relapse rate; Pregnancy rate; Toxic Side Effect Peking University People's Hospital Female 17 Years to 45 Years (Child, Adult) 82 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2022PHB416 01/06/2023 31/08/2025 31/10/2025 01/09/2023 16/05/2023 https://ClinicalTrials.gov/show/NCT05675787 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Atorvastatin Safety and/or Dose; Response rate; Biomarker; Other (specify) Phase 2 DB01117 N
NCT03024684 Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment SHOT Recruiting HepatoCellular Carcinoma Drug: Atorvastatin; Drug: Placebo Oral Tablet 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart; occurrence of clinical complications related to hepatic decompensation Chiayi Christian Hospital; E-DA Hospital; National Taiwan University Hospital; Taichung Veterans General Hospital; Mackay Memorial Hospital; Tainan Municipal Hospital; National Cheng-Kung University Hospital; Chi Mei Medical Hospital All 20 Years to 75 Years (Adult, Older Adult) 240 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention 105005 01/03/2017 01/01/2025 01/01/2027 19/01/2017 28/04/2022 https://ClinicalTrials.gov/show/NCT03024684 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan GI Liver Cancer Atorvastatin Recurrence rate Phase 3 DB01117 N
NCT05483010 Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS) Not yet recruiting Clonal Cytopenia of Undetermined Significance|Myelodysplastic Syndromes Drug: Atorvastatin; Drug: Rosuvastatin Change in hs-CTRP levels in peripheral blood during statin therapy; Change in allele burden (VAF) of somatic mutation Washington University School of Medicine All 18 Years and older (Adult, Older Adult) 16 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 202211020 01/03/2024 30/04/2027 30/04/2027 08/01/2022 19/12/2023 https://ClinicalTrials.gov/show/NCT05483010 Other (specify) Hospital/University/Research Institute N N N United States Other Haem-onc Myelodysplastic Syndromes Atorvastatin; Rosuvastatin DFS/RFS/EFS; Biomarker Phase 2 DB01117; DB10276 N
NCT02840227 The Effect of Combined General/Regional Anesthesia on Cancer Recurrence in Patients Having Lung Cancer Resections Active, not recruiting Non-small Cell Lung Cancer Procedure: General anesthesia with opioid analgesia; Procedure: Combined general/epidural anesthesia Cancer-free survival; Pain intensity; SF-12 Health Survey; McGill Pain Questionnaire; Neuropathic Pain Questionnaire; Opioid use The Cleveland Clinic; Shanghai Chest Hospital All 18 Years to 85 Years (Adult, Older Adult) 2000 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 91051 12/01/2013 06/01/2024 12/01/2024 21/07/2016 18/06/2023 https://ClinicalTrials.gov/show/NCT02840227 Localised/Locoregional Hospital/University/Research Institute Y N N United States Lung Non-Small Cell Lung Cancer Propofol Safety and/or Dose; DFS/RFS/EFS; Other (specify) Other DB00571 N
NCT04657237 Effect of Anesthesia on Expression of Programmed Death-1 and Programmed Death-1 Ligand in Breast Cancer Unknown status Programmed Cell Death 1 Procedure: Thoracic Paravertebral block change in level of PD1 and PD1 ligand postoperatively; total request of analgesia Assiut University Female 18 Years to 65 Years (Adult, Older Adult) 20 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Other 359 01/01/2017 09/01/2021 11/01/2021 12/08/2020 12/08/2020 https://ClinicalTrials.gov/show/NCT04657237 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Acetaminophen Biomarker Other DB00819 N
NCT05016349 Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer. Unknown status Breast Cancer Female Drug: All trans-retinoic acid; Drug: 13-Cis Retinoic Acid plus Tocopherol; Drug: Mifepristone; Drug: Cannabidiol; Drug: 9 cis retinoic acid; Drug: Tamoxifen; Drug: Standard therapy Cytokeratin 5 (CK5)-expression; To evaluate and compare the pathological complete response (pCR) rates; To evaluate the overall clinical response rate; Estradiol and progesterone levels in breast tissue and plasma assessed by liquid chromatography/tandem mass spectrometry; Retinoic acid, TAM and their metabolites levels in breast tissue and plasma; Effect on level of serum tumor markers compared to baseline Mahmoud Ramadan mohamed Elkazzaz; Ministry of Health, Saudi Arabia; Kafrelsheikh University Female 18 Years to 70 Years (Adult, Older Adult) 160 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment New theory(Tamoxifen retinoic) 08/01/2021 10/01/2021 12/01/2021 23/08/2021 23/08/2021 https://ClinicalTrials.gov/show/NCT05016349 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y Y N Saudi Arabia Breast Any Breast Cancer Mifepristone Response rate; Biomarker Phase 3 DB09031 N
NCT05281276 Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC) Recruiting Metastatic Colorectal Cancer Drug: chidamide; Drug: celecoxib Maximum Feasible Dose (MFD); Pharmacokinetics profiles-(AUC0-t); Pharmacokinetics profiles-(AUC0- ); Pharmacokinetics profiles-(Cmax); Pharmacokinetics profiles-(Tmax); Pharmacokinetics profiles-(T1/2); Pharmacokinetics profiles-(Kel); Pharmacokinetics profiles-(AUC0- ,ss); Pharmacokinetics profiles-(Cave,ss); Pharmacokinetics profiles-(Cmin,ss); Pharmacokinetics profiles-(Cmax,ss); Pharmacokinetics profiles-(Tmax,ss); Pharmacokinetics profiles-(DF); Progression-free survival; Objective response Taipei Medical University Shuang Ho Hospital All 20 Years and older (Adult, Older Adult) 12 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment N202007026 20/09/2022 31/12/2024 31/12/2024 16/03/2022 14/12/2023 https://ClinicalTrials.gov/show/NCT05281276 Advanced/Metastatic Hospital/University/Research Institute N N N Taiwan GI Colon Cancer; Rectal Cancer Celecoxib Safety and/or Dose; PFS Phase 1 DB00567 N
NCT02885974 Celecoxib With Chemotherapy in Localized, Muscle-Invasive Bladder Cancer BLAST Recruiting Bladder Cancer Drug: Celecoxib; Drug: Gemcitabine; Drug: Cisplatin mRNA expression in pre- and post-chemotherapy tissues; Number and severity of adverse events; Pathological disease stage at cystectomy, including the rate of pT0 and the rate of < pT2.; Two-year progression free survival; Two-year overall survival Baylor College of Medicine All 18 Years and older (Adult, Older Adult) 15 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H-36486 12/01/2016 12/01/2023 12/01/2023 09/01/2016 13/07/2023 https://ClinicalTrials.gov/show/NCT02885974 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Bladder Cancer Celecoxib Biomarker Phase 1 DB00567 N
NCT03645187 Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer Recruiting Colon Cancer Stage Drug: FOLFERI; Drug: Folferi and celecoxib number of patients with improved radiology Sherief Abd-Elsalam; Tanta University All 18 Years to 70 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment celecoxib 08/01/2018 08/01/2025 12/01/2025 24/08/2018 20/04/2021 https://ClinicalTrials.gov/show/NCT03645187 Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Celecoxib Response rate Phase 4 DB00567 N
NCT03498326 Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer GCRP Recruiting Pancreatic Cancer|Chemotherapy Effect Drug: Gemcitabine disease free survival; overall survival; Carbohydrate antigen 19-9; Quality of Life; Common Toxicity Criteria for Adverse Effects Second Affiliated Hospital, School of Medicine, Zhejiang University All 18 Years to 90 Years (Adult, Older Adult) 480 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SAHZhejiangU-GCRP 04/02/2018 31/03/2023 31/03/2030 13/04/2018 30/05/2018 https://ClinicalTrials.gov/show/NCT03498326 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Pancreatic Cancer Celecoxib DFS/RFS/EFS Phase 2 DB00567 N
NCT03864575 An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced Cold Solid Tumors NICE-COMBO Unknown status Metastatic Cancer Drug: Celecoxib 400 mg objective response rate; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; Efficacy - Duration of response (DOR); Efficacy - Time to response (TTR); Disease control rate (DCR); Progression-free survival (PFS); Overall survival (OS) Cliniques universitaires Saint-Luc- Universit Catholique de Louvain All 18 Years and older (Adult, Older Adult) 68 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LUC-19-002 15/08/2019 15/06/2021 15/06/2021 03/06/2019 07/12/2019 https://ClinicalTrials.gov/show/NCT03864575 Advanced/Metastatic Hospital/University/Research Institute N N N Belgium Multiple cancer types Multiple cancer types Celecoxib Response rate Phase 2 DB00567 N
NCT05578287 RC48 Plus Tislelizumab, Low-dose Capecitabine and Celecoxib for HER2-positive Metastatic Colorectal Cancer DETECT Recruiting Colorectal Cancer Drug: Anti-HER2 ADC Safety; Feasibility; Objective response rate; disease control rate,DCR; Progression-free survival (PFS); Overall Survival (OS) Sun Yat-sen University All 18 Years to 75 Years (Adult, Older Adult) 29 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GIHSYSU-26 18/07/2023 15/12/2024 25/12/2025 13/10/2022 12/07/2023 https://ClinicalTrials.gov/show/NCT05578287 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Celecoxib Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00567 N
NCT01150045 Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery Active, not recruiting Colorectal Cancer Drug: celecoxib; Drug: 5-fluorouracil; Other: placebo; Drug: oxaliplatin; Drug: leucovorin Disease-free Survival; Overall Survival Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 2527 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment CALGB-80702; U10CA031946; CDR0000675693 06/01/2010 28/02/2020 24/06/2010 08/06/2021 22/03/2022 https://ClinicalTrials.gov/show/NCT01150045 Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N United States GI Colon Cancer Celecoxib DFS/RFS/EFS Phase 3 DB00567 N
NCT03896113 Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma CELEBRIDO Unknown status Endometrium Cancer Drug: Celecoxib 200mg capsule Reduction of tumoural cells expression IDO after celecoxib treatment. If more than 10 of all the tumoural cells have a staining for IDO, the tumour is considered as IDO (+), if less than 10 .; Modification of tumoural T Cells infiltration after the treatment with celecoxib. The number of Cluster of Differenciation (CD) 4 and CD8 T cells will be counted before and after the treatment.; Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Event Version 4.0 (CTCAE v4.0). Cliniques universitaires Saint-Luc- Universit Catholique de Louvain Female 18 Years to 99 Years (Adult, Older Adult) 48 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LUC19-001 13/11/2019 30/06/2022 30/06/2022 29/03/2019 01/10/2020 https://ClinicalTrials.gov/show/NCT03896113 Localised/Locoregional Hospital/University/Research Institute N N N Belgium Gynaecological Endometrial Cancer Celecoxib Biomarker Phase 2 DB00567 N
NCT05933980 Sintilimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer SINCERE Not yet recruiting Colorectal Cancer|Liver Metastases|MSS Drug: Sinti+Rego+Cele ORR; OS; PFS; DCR; DoR Sun Yat-sen University All 18 Years to 100 Years (Adult, Older Adult) 33 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GIHSYSU26 20/08/2023 20/08/2024 20/08/2025 07/06/2023 07/06/2023 https://ClinicalTrials.gov/show/NCT05933980 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Celecoxib Response rate; PFS; OS Phase 2 DB00567 N
NCT03926338 Toripalimab With or Without Celecoxib as Neoadjuvant Therapy in Resectable dMMR/MSI-H Colorectal Cancer PICC Recruiting Colorectal Cancer|Mismatch Repair-deficient (dMMR)|Microsatellite Instability-high (MSI-H)|Neoadjuvant Therapy Drug: Neoadjuvant therapy with PD-1 inhibitor plus COX inhibitor; Drug: Neoadjuvant therapy with PD-1 inhibitor Disease-free survival (DFS); Pathological complete response (pCR) rates; Overall survival (OS); R0 resection rates; Surgical and perioperative treatment safety; Surgery feasibility Sun Yat-sen University All 18 Years to 75 Years (Adult, Older Adult) 69 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GIHSYSU-14 05/10/2019 05/01/2023 05/01/2026 24/04/2019 28/02/2023 https://ClinicalTrials.gov/show/NCT03926338 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Celecoxib Safety and/or Dose; Response rate; OS; DFS/RFS/EFS Phase 1/2 DB00567 N
NCT02574728 Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors AflacST1502 Recruiting Cancer Drug: Sirolimus; Drug: Celecoxib; Drug: Etoposide; Drug: Cyclophosphamide Change in radiographic response to treatment for solid tumors; Change in radiographic response to treatment for central nervous system (CNS) tumors; Number of adverse events Emory University; Cannonball Kids' Cancer Foundation; Hyundai Hope On Wheels All 12 Months to 30 Years (Child, Adult) 60 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00082488 06/01/2015 01/01/2024 01/01/2024 14/10/2015 20/12/2022 https://ClinicalTrials.gov/show/NCT02574728 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Multiple cancer types Multiple cancer types Celecoxib; Sirolimus Response rate Phase 2 DB00567; DB01261 N
NCT05731726 Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer Recruiting pMMR|MSS|MSI-L|Locally Advanced Rectal Carcinoma Drug: Serplilumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Celecoxib Pathological complete response rates; Major pathological response rates; Rate of clinical complete response rate (cCR); R0 resection rates; Treatment-related adverse events.; Detection of MRD; single cell sequence Zhejiang University All 18 Years to 75 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ASTRUM-REC01 22/02/2023 20/02/2024 20/02/2025 16/02/2023 13/03/2023 https://ClinicalTrials.gov/show/NCT05731726 Localised/Locoregional Hospital/University/Research Institute N N N China GI Rectal Cancer Celecoxib Response rate Phase 2 DB00567 N
NCT02432378 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Suspended Cancer of Ovary|Cancer of the Ovary|Neoplasms, Ovarian|Ovarian Cancer|Ovary Cancer|Ovary Neoplasms Biological: Cisplatin + celecoxib + DC vaccine; Biological: Cisplatin + CKM + Celecoxib + DC Vaccine Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid.; Number of adverse events for the different combinations; Change in the number of CD3+CD8+ T cells in the peritoneal fluid.; Change in the number of effector CD8+ T cells in the peritoneal fluid.; Change in the number of CD4+ T cells in the peritoneal fluid.; Change in the number of Tregs in the peritoneal fluid.; Change in the number of myeloid-derived suppressor cells in the peritoneal fluid. Roswell Park Cancer Institute; AIM ImmunoTech Inc.; National Cancer Institute (NCI); University of Pittsburgh Female 18 Years and older (Adult, Older Adult) 25 Other; Industry; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 11-128; 5P01CA132714 09/04/2015 31/12/2025 06/01/2026 05/04/2015 19/10/2022 https://ClinicalTrials.gov/show/NCT02432378 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Gynaecological Primary Peritoneal Cancer; Ovarian Epithelial Cancer; Fallopian Tube Cancer Celecoxib Biomarker Phase 1/2 DB00567 N
NCT03728179 RACIN in Patients With Advanced TIL-negative Solid Tumors RACIN Unknown status Solid Tumor, Adult Combination Product: Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib Phases Ia and Ib: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Maximum Tolerated dose (MTD) or recommended phase Ib dose of low-dose irradiation for radio-immunotherapy combination (RP1bD).; Objective response rate (ORR); Disease Control Rate (DCR); Progression free survival (PFS) rate; Time to Progression (TTP):; Overall survival (OS) Centre Hospitalier Universitaire Vaudois All 18 Years and older (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CHUV-DO-0003-RACIN_2017 16/01/2019 30/03/2022 30/03/2022 11/01/2018 14/01/2022 https://ClinicalTrials.gov/show/NCT03728179 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N Switzerland Multiple cancer types Any solid tumours Acetylsalicylic Acid; Celecoxib Safety and/or Dose; Response rate Phase 1 DB01048; DB00567 N
NCT04162873 Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer Recruiting Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8|Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8|Nasal Cavity and Paranasal Sinus Carcinoma|Oral Cavity Carcinoma|Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8|Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8|Recurrent Hypopharyngeal Carcinoma|Recurrent Laryngeal Carcinoma|Recurrent Nasal Cavity and Paranasal Sinus Carcinoma|Recurrent Oral Cavity Carcinoma|Recurrent Oropharyngeal Carcinoma|Stage III Hypopharyngeal Carcinoma AJCC v8|Stage III Laryngeal Cancer AJCC v8|Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8|Stage IV Hypopharyngeal Carcinoma AJCC v8|Stage IV Laryngeal Cancer AJCC v8|Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8|Stage IVA Hypopharyngeal Carcinoma AJCC v8|Stage IVA Laryngeal Cancer AJCC v8|Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8|Stage IVB Hypopharyngeal Carcinoma AJCC v8|Stage IVB Laryngeal Cancer AJCC v8|Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8|Stage IVC Hypopharyngeal Carcinoma AJCC v8|Stage IVC Laryngeal Cancer AJCC v8|Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Drug: Celecoxib; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration The number of days from surgery to the initiation of radiation and adjuvant therapy; Assessment of overall pain control and management for patients on celecoxib compared to placebo.; Assessment of functional outcomes for patients on celecoxib compared to placebo; To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.; Assessment of the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo. University of Utah; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 60 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment HCI124211; NCI-2019-07104; P30CA042014 27/11/2019 10/12/2024 10/12/2025 14/11/2019 26/06/2023 https://ClinicalTrials.gov/show/NCT04162873 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Head and Neck Any head and neck cancer Celecoxib Other (specify) Phase 2 DB00567 N
NCT01881048 Window of Opportunity Study Targeting the Inflammatory Milieu Active, not recruiting Stage IA Breast Cancer|Stage IB Breast Cancer|Stage II Breast Cancer|Stage IIIA Breast Cancer|Stage IIIB Breast Cancer|Stage IIIC Breast Cancer|Stage IV Breast Cancer Dietary Supplement: Omega-3 fatty acid; Drug: Celecoxib Change in mean Ki-67 index in patients receiving either omega-3 fatty acid or celecoxib for 1 or more weeks as compared to controls University of Colorado, Denver Female 18 Years to 50 Years (Adult) 42 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 08-0104.cc; NCI-2011-02967 12/08/2009 14/01/2014 12/01/2023 19/06/2013 31/01/2023 https://ClinicalTrials.gov/show/NCT01881048 Localised/Locoregional Hospital/University/Research Institute Y Y N United States Breast Any Breast Cancer Celecoxib; Omega 3 Biomarker Phase 1 DB00567; DB00338 N
NCT03184493 Celebrex and Metformin for Postoperative Hepatocellular Carcinoma XBD Unknown status Liver Cancer Drug: Celebrex plus Metformin; Drug: Celebrex; Drug: Metformin Number of participants with tumor recurrence Guangxi Medical University All 18 Years to 75 Years (Adult, Older Adult) 200 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment Celebrex for HCC 06/02/2017 12/01/2020 06/01/2021 06/12/2017 31/05/2019 https://ClinicalTrials.gov/show/NCT03184493 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y Y N China GI Liver Cancer Celecoxib; Metformin DFS/RFS/EFS Phase 3 DB00567; DB00703 N
NCT00268476 Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy STAMPEDE Active, not recruiting Prostate Cancer Drug: Celecoxib; Drug: Docetaxel; Drug: Prednisolone; Drug: ADT; Drug: Zoledronic Acid; Drug: Abiraterone; Radiation: Radiotherapy to the prostate; Drug: Enzalutamide; Drug: Metformin; Drug: Transdermal Oestradiol Overall survival; Failure-free survival; Cost effectiveness by EuroQol; Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item; Number of participants with treatment-related side effects as assessed by CTCAE v4.0; Skeletal related events; Biochemical failure; Progression-free survival; Lymph node progression; Distant metastases; Treatment for progression; Disease-specific survival; Non-prostate cancer death; Metabolic effects Medical Research Council Male up to 120 Years (Child, Adult, Older Adult) 11992 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CDR0000455008; MRC-STAMPEDE; EU-205102; PR08; ISRCTN78818544; 2004-000193-31 07/08/2005 03/01/2026 12/01/2030 22/12/2005 18/04/2023 https://ClinicalTrials.gov/show/NCT00268476 Advanced/Metastatic Hospital/University/Research Institute Y Y N United Kingdom Urological Prostate Cancer Celecoxib; Metformin; Zoledronic Acid OS Phase 2/3 DB00567; DB00703 N
NCT03026140 Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer NICHE Recruiting Colon Carcinoma Drug: Nivolumab; Drug: Ipilimumab; Drug: Celecoxib 200mg; Drug: BMS-986253; Drug: BMS-986016 Incidence of adverse events during the treatment and follow-up (safety); Disease free survival; Immune activating capacity of short-term pre-operative immunotherapy; Relapse free survival The Netherlands Cancer Institute; Bristol-Myers Squibb All 18 Years and older (Adult, Older Adult) 268 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment N16NCI 29/03/2017 12/01/2024 12/01/2024 20/01/2017 26/01/2023 https://ClinicalTrials.gov/show/NCT03026140 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands GI Colon Cancer Celecoxib Safety and/or Dose; DFS/RFS/EFS Phase 2 DB00567 N
NCT03638297 PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer PCOX Recruiting Colorectal Cancer Drug: PD-1 antibody + cox inhibitor Response rate; Progression free survival; Overall survival time; disease control rate; Toxicity assessed using the NCI common toxicity criteria, version 4.0.; duration of response Sun Yat-sen University All 18 Years to 80 Years (Adult, Older Adult) 29 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GIHSYSU13 23/08/2018 20/08/2022 31/08/2025 20/08/2018 17/10/2023 https://ClinicalTrials.gov/show/NCT03638297 Localised/Locoregional Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Response rate; PFS Phase 2 DB01048 N
NCT02748707 Effect of COX-2 and EGFR Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study ERLO-XIB Active, not recruiting Oral Squamous Cell Carcinoma|Carcinoma of Buccal Mucosa|Tongue Cancers|Head and Neck Cancers Drug: Arm1; Drug: Arm 2; Drug: Arm 3; Other: Arm 4 Change in expression of selected biomarkers in tissue samples, assessed by immunohistochemistry (IHC) and PCR; Clinical and radiological Change in tumor size and appearance Tata Memorial Hospital All 18 Years to 75 Years (Adult, Older Adult) 64 Other Interventional Study Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 830 18/08/2015 02/12/2018 04/01/2023 22/04/2016 28/04/2022 https://ClinicalTrials.gov/show/NCT02748707 Localised/Locoregional Hospital/University/Research Institute Y Y N India Head and Neck Oropharyngeal Cancer Celecoxib Biomarker Phase 2 DB00567 N
NCT04093323 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma Suspended HLA-A2 Positive Cells Present|Refractory Melanoma Biological: Alpha-type-1 Polarized Dendritic Cells; Drug: Celecoxib; Drug: PD-1 Ligand Inhibitor; Drug: PD1 Inhibitor; Biological: Recombinant Interferon Alfa-2b; Drug: Rintatolimod Objective response rate (ORR); ORR; Durable objective response rate (>= 6 months) Roswell Park Cancer Institute; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 24 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 82419; NCI-2019-05911; P01CA234212 31/12/2023 22/10/2025 22/12/2025 18/09/2019 30/11/2023 https://ClinicalTrials.gov/show/NCT04093323 Recurrent/Refractory Hospital/University/Research Institute N N N United States Skin Melanoma Celecoxib Response rate Phase 2 DB00567 N
NCT02030964 N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan DFMO Active, not recruiting Neuroblastoma Drug: DFMO; Drug: Celecoxib; Drug: Cyclophosphamide; Drug: Topotecan Number of participants with adverse events as a measure of safety and tolerability. New Approaches to Neuroblastoma Therapy Consortium; National Cancer Institute (NCI) All 2 Years to 30 Years (Child, Adult) 30 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment N2012-01; P01CA081403 12/01/2013 12/01/2023 12/01/2023 01/09/2014 31/01/2023 https://ClinicalTrials.gov/show/NCT02030964 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Other Neuroblastoma Celecoxib; Eflornithine Safety and/or Dose Phase 1 DB00567; DB06210 N
NCT03710876 Efficacy Safety of rAd-IFN Administered With Celecoxib Gemcitabine in Patients With Malignant Pleural Mesothelioma INFINITE Active, not recruiting Malignant Pleural Mesothelioma Biological: rAd-IFN; Drug: Celecoxib Oral Product; Drug: Gemcitabine Overall Survival; Survival rate; Progression Free Survival; Best response Trizell Ltd; University of Pennsylvania All 18 Years and older (Adult, Older Adult) 53 Industry; Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment rAd-IFN-MM-301; 2017-003169-82 21/01/2019 11/01/2023 11/01/2024 18/10/2018 26/10/2021 https://ClinicalTrials.gov/show/NCT03710876 Palliative Recurrent/Refractory Company Y N N United States Lung Malignant Mesothelioma Celecoxib OS Phase 3 DB00567 N
NCT02641314 Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma METRO-NB2012 Recruiting Recurrent Neuroblastoma Drug: metronomic therapy non-inferiority of EFS compared to historical control group; disease control rate at 6 months; Overall survival; hospitalization days; number of transfusion days; drop-out rate; disease control rate at 12 months University of Cologne All 2 Years to 20 Years (Child, Adult) 26 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Uni-Koeln-1495; 2011-004593-29 22/12/2016 12/01/2023 12/01/2023 29/12/2015 11/04/2022 https://ClinicalTrials.gov/show/NCT02641314 Recurrent/Refractory Hospital/University/Research Institute N N Y Germany Other Neuroblastoma Celecoxib; Propranolol DFS/RFS/EFS Phase 2 DB00567; DB00165 N
NCT01356290 Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT MEMMAT Recruiting Medulloblastoma Recurrent|Ependymoma Recurrent|ATRT Recurrent Drug: Bevacizumab; Drug: Thalidomide; Drug: Celecoxib; Drug: Fenofibric acid; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Etoposide phosphate; Drug: Cytarabine Efficacy; Overall survival rate; Progression free survival rate; Toxicity; Feasibility; Quality of life; Prognostic factors; Angiogenic factors Medical University of Vienna All up to 19 Years (Child, Adult) 100 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MUV-MEMMAT-01 04/01/2014 04/01/2026 04/01/2026 19/05/2011 21/04/2023 https://ClinicalTrials.gov/show/NCT01356290 Recurrent/Refractory Hospital/University/Research Institute N N Y Austria CNS Ependymoma; Central Nervous System Atypical Teratoid/Rhabdoid Tumor; Medulloblastoma Celecoxib; Fenofibrate Response rate Phase 2 DB00567; DB00800 N
NCT04397679 Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma Recruiting Glioblastoma|Gliosarcoma Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy (IMRT); Drug: Temozolomide; Drug: Chloroquine; Procedure: Tumor Treating Fields Therapy (TTF) Proportion of patients who develop a specific acute toxicity (dermatitis); Incidence of adverse events Barbara Ann Karmanos Cancer Institute; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 10 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2018-148; P30CA022453 08/12/2021 27/04/2024 27/04/2025 21/05/2020 24/05/2023 https://ClinicalTrials.gov/show/NCT04397679 Any/All Stages Hospital/University/Research Institute N N N United States CNS Glioblastoma Chloroquine Safety and/or Dose Phase 1 DB00477 N
NCT04772846 Chloroquine for Glioblastoma. Unknown status Glioblastoma Drug: Oral tablet; Drug: Placebo Survival duration after surgery; End-point evaluation, survival at three years Egyptian Medical Syndicate All 18 Years to 70 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Care Provider)|Primary Purpose: Treatment CQGBM 03/01/2018 12/01/2020 03/01/2021 26/02/2021 26/02/2021 https://ClinicalTrials.gov/show/NCT04772846 Localised/Locoregional Collaborative Group Y N N Egypt CNS Glioblastoma Chloroquine OS Phase 1/2 DB00477 N
NCT05462496 Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer Recruiting Pancreatic Cancer Procedure: Biopsy; Drug: FOLFIRINOX; Drug: Ciprofloxacin; Drug: Metronidazole; Drug: Pembrolizumab; Procedure: Surgical Resection Achievement of overall immune response; Adverse event incidence rate; R0 resection rate; Proportion of participants with histologic regression score 0, 1, or 2; Overall response rate (ORR); Overall survival rate (OS) Icahn School of Medicine at Mount Sinai All 19 Years and older (Adult, Older Adult) 3 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY-21-01814 13/03/2023 12/01/2024 07/01/2025 18/07/2022 18/11/2023 https://ClinicalTrials.gov/show/NCT05462496 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Ciprofloxacin; Metronidazole Other (specify) Phase 2 DB00215; DB01011 N
NCT04523987 A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. Recruiting Metastatic Pancreatic Ductal Adenocarcinoma Drug: Ciprofloxacin Antitumor Effect - Solid Tumors National University Hospital, Singapore All 21 Years to 99 Years (Adult, Older Adult) 10 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PA02/07/18 22/02/2019 02/01/2023 02/01/2024 24/08/2020 24/08/2020 https://ClinicalTrials.gov/show/NCT04523987 Advanced/Metastatic Hospital/University/Research Institute N N N Singapore GI Pancreatic Cancer Ciprofloxacin Response rate Phase 1 DB00215 N
NCT02387203 Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin Active, not recruiting Pseudomyxoma Peritonei|Appendiceal Neoplasms Drug: PrevPac (Prevacid, Amoxicillin, Clarithromycin) Overall survival; Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease Mercy Medical Center All 21 Years and older (Adult, Older Adult) 80 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MMC-2014-53 01/01/2015 12/01/2024 12/01/2024 03/12/2015 14/03/2023 https://ClinicalTrials.gov/show/NCT02387203 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Other GI Clarithromycin; Lansoprazole PFS; OS Phase 2 DB00283; DB17289 N
NCT01745588 Autologous Stem Cell Transplant With Pomalidomide (CC-4047 ) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma Active, not recruiting Multiple Myeloma Drug: Pomalidomide; Procedure: stem cell; Drug: Dexamethasone; Drug: Clarithromycin overall response rate; safety analyses; overall survival; progression free survival; Determine the rates of Grade 3 toxicities Memorial Sloan Kettering Cancer Center; Celgene Corporation; Weill Medical College of Cornell University; North Shore University Hospital; Rutgers Cancer Institute of New Jersey; State University of New York - Upstate Medical University All 18 Years and older (Adult, Older Adult) 23 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 12-138 12/01/2012 12/01/2024 12/01/2024 12/10/2012 07/03/2023 https://ClinicalTrials.gov/show/NCT01745588 Recurrent/Refractory Hospital/University/Research Institute N Y N United States Other Haem-onc Multiple Myeloma Clarithromycin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00283 N
NCT04302324 A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab Recruiting Multiple Myeloma|Refractory Multiple Myeloma|Relapse Multiple Myeloma Drug: Daratumumab SC; Drug: Clarithromycin; Drug: Pomalidomide; Drug: Dexamethasone Very Good Partial Response Rate or better within 8 cycles of induction therapy; Progression-Free Survival; Overall Survival; Complete Response Rate or Better; Time to Progression; Time to Next Therapy; Duration of Response; Rate of minimal residual disease (MRD) negativity; Rate of improvement in response during maintenance therapy; Time to Best Response; Overall Response Rate; Very Good Partial Response (VGPR) Rate or better Weill Medical College of Cornell University; Janssen Scientific Affairs, LLC All 18 Years to 75 Years (Adult, Older Adult) 40 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 19-12021155 28/10/2021 09/01/2024 01/01/2034 03/10/2020 07/05/2023 https://ClinicalTrials.gov/show/NCT04302324 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 2 DB00283 N
NCT02542657 Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma Active, not recruiting Myeloma Drug: Clarithromycin; Drug: Dexamethasone; Drug: Ixazomib Citrate; Drug: Pomalidomide MTD of clarithromycin when given in combination with ixazomib citrate, pomalidomide, and dexamethasone assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I); Clinical best response Joseph Tuscano; Takeda; Celgene; University of California, Davis All 18 Years and older (Adult, Older Adult) 30 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 728937; UCDCC#253; X16043; PO-TR-MM-PI-004614 10/01/2015 08/01/2024 12/01/2024 09/07/2015 09/01/2023 https://ClinicalTrials.gov/show/NCT02542657 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Clarithromycin Safety and/or Dose; Response rate Phase 1/2 DB00283 N
NCT04287660 Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients Recruiting Multiple Myeloma Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells Overall response rate (ORR); Overall survival (OS); Event-free survival (EFS); Cumulative incidence of relapse(CIR); Number of adverse events The First Affiliated Hospital of Soochow University; Changshu Frist People's Hospital; The Second People's Hospital of Huai'an; Affiliated Hospital of Jiangnan University; Jiangsu Province Hospital of Traditional Chinese Medicine; Jiangyin People's Hospital; Jingjiang People's Hospital; The Third People's Hospital of Kunshan; Lianyungang Hospital Affiliated Bengbu Medical College; Suzhou Municipal Hospital; Zhangjiagang First People's Hospital; Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd; The First Affiliated Hospital with Nanjing Medical University; The first Affiliated Hospital of Nanjing University Medical School All 18 Years to 75 Years (Adult, Older Adult) 20 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BiRd-01 19/10/2017 31/01/2023 31/01/2025 27/02/2020 25/10/2021 https://ClinicalTrials.gov/show/NCT04287660 Primary/Main Curative Any/All Stages Hospital/University/Research Institute N N N China Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 3 DB00283 N
NCT01559935 Carfilzomib, Clarithromycin (Biaxin ), Lenalidomide (Revlimid ), and Dexamethasone (Decadron ) [Car-BiRD] Therapy for Subjects With Multiple Myeloma CarBiRD Active, not recruiting Multiple Myeloma Drug: carfilzomib; Drug: Dexamethasone; Drug: Clarithromycin; Drug: Lenalidomide Response to Car-BiRD Treatment.; Event Free Survival; MRD Negativity Following CarBiRD Regimen; Progression Free Survival; Stem Cells Collection Weill Medical College of Cornell University; Onyx Therapeutics, Inc. All 18 Years and older (Adult, Older Adult) 74 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1108011903 03/01/2012 06/07/2016 03/01/2024 21/03/2012 22/03/2017 14/04/2023 https://ClinicalTrials.gov/show/NCT01559935 Any/All Stages Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 2 DB00283 N
NCT02343042 Selinexor and Backbone Treatments of Multiple Myeloma Patients STOMP Active, not recruiting Multiple Myeloma Drug: Selinexor; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide; Drug: Bortezomib; Drug: Daratumumab; Drug: Carfilzomib; Drug: Ixazomib; Drug: Elotuzumab; Drug: Clarithromycin; Drug: Belantamab Mafodotin Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD); Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D); Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor; Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor; Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf); Phase 2 (Expansion): Overall response rate (ORR); Phase 2 (Expansion): Duration of response (DOR); Phase 2 (Expansion): Clinical Benefit Rate (CBR) Karyopharm Therapeutics Inc All 18 Years and older (Adult, Older Adult) 518 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment KCP-330-017 10/01/2015 01/01/2025 01/01/2025 21/01/2015 31/08/2023 https://ClinicalTrials.gov/show/NCT02343042 Recurrent/Refractory Company N Y N United States Other Haem-onc Multiple Myeloma Clarithromycin Safety and/or Dose; Response rate Phase 1/2 DB00283 N
NCT03031483 Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma Active, not recruiting Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Drug: clarithromycin and lenalidomide Tumor response assessment; Adverse Events assessments International Extranodal Lymphoma Study Group (IELSG) All 18 Years to 80 Years (Adult, Older Adult) 44 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IELSG40 04/03/2017 13/11/2019 11/01/2029 25/01/2017 11/07/2022 https://ClinicalTrials.gov/show/NCT03031483 Recurrent/Refractory Collaborative Group N N N Italy Lymphoma Lymphoma - Other Clarithromycin Response rate Phase 2 DB00283 N
NCT03664115 Itraconazole in Non Small Cell Lung Cancer Unknown status Lung Cancer Drug: Itraconazole 200 mg; Drug: Chemotherapy one year progression free survival; one year overall survival; Radiological response; quality of life; Adverse effects of Itraconazole. Ain Shams University All 18 Years and older (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 17585 07/02/2018 12/02/2019 12/02/2020 09/10/2018 09/10/2018 https://ClinicalTrials.gov/show/NCT03664115 Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt Lung Non-Small Cell Lung Cancer Itraconazole PFS Phase 2 DB00602 N
NCT01562626 Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors Suspended Tumors|Neoplasms|Cancer Drug: APS001F; Drug: Flucytosine (5-FC); Drug: 10 maltose Number of participants with adverse events as a measure of safety and tolerability of APS001F treatment plus 5-FC and maltose Anaeropharma Science, Inc. All 18 Years and older (Adult, Older Adult) 75 Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment APS001F-001 09/01/2012 05/01/2021 05/01/2021 26/03/2012 05/12/2021 https://ClinicalTrials.gov/show/NCT01562626 Advanced/Metastatic Company N N N United States Multiple cancer types Any solid tumours Flucytosine Safety and/or Dose Phase 1/2 DB04841 N
NCT03294486 Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients ONCOVIRAC Unknown status Glioblastoma|Brain Cancer Drug: Combination of TG6002 and 5-flucytosine (5-FC, Ancotil ) Number of Participant with Dose Limiting Toxicities defined as Any of the following treatment-related adverse events (AEs) is evaluated and reported from Day 1 through Day 26; as assessed by NCI-CTCAE, version 4.03; Number of patients without documented tumor progression at 6 months from date of first TG6002 infusion according to Response Assessment Neuro-Oncology Criteria (Wen et al., 2010, JCO, PMID:20231676); TG6002 recommended dose prior to the Phase 2a part of the study (RP2D) in combination with 5-FC (Maximum Plasma Concentration [Cmax]); Overall Survival (OS); Relative quantification of circulating viral DNA; Blood pharmacokinetics of 5-FC; Blood pharmacokinetics of 5-Fluorouraril (5-FU); Blood pharmacokinetics of final metabolite a-fluoro-B-alanine(FBAL); Viral shedding in saliva, urine and feces; Humoral response; Isolation of peripheral blood mononuclear cells (PBMC);; Metabolic Response; Safety and tolerability : Incidence of Treatment; evaluation of treatement-releated adverse events Assistance Publique - H pitaux de Paris; Transgene All 18 Years and older (Adult, Older Adult) 78 Other; Industry Interventional Study Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment P150936; 2015-004452-21 10/12/2017 05/01/2019 09/01/2021 27/09/2017 11/06/2017 https://ClinicalTrials.gov/show/NCT03294486 Recurrent/Refractory Company N N N France CNS Glioblastoma Flucytosine Safety and/or Dose; PFS Phase 1/2 DB04841 N
NCT04736589 Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway Not yet recruiting Breast Cancer Drug: Inetetamab; Drug: Rapamycin; Drug: Pyrotinib; Drug: Chemotherapy Progressive-free Survival (PFS); Overall Response Rate (ORR); Overall Survival OS ; Clinical Benefit Rate (CBR); Safety(AEs and SAEs) Peking Union Medical College Female 18 Years to 85 Years (Adult, Older Adult) 270 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IR-1.1 02/02/2021 02/02/2024 02/02/2027 02/03/2021 02/03/2021 https://ClinicalTrials.gov/show/NCT04736589 Palliative Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Breast Breast Cancer - HER2+ Sirolimus PFS Phase 3 DB01261 N
NCT02749513 Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients Unknown status Esophageal Cancer Drug: Itraconazole Inhibition of Hedgehog pathway signaling as measured by real-time PCR.; Inhibition of VEGFR2 pathway signaling as measured by Western blot Dallas VA Medical Center All 18 Years and older (Adult, Older Adult) 18 U.S. Fed Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Other 15-084 01/01/2016 09/01/2019 10/01/2022 25/04/2016 11/04/2021 https://ClinicalTrials.gov/show/NCT02749513 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Esophageal Cancer Itraconazole Biomarker Phase 1 DB00602 N
NCT05679388 A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients Recruiting Prostate Cancer|Prostate Cancer Metastatic|Prostate Adenocarcinoma Drug: Relugolix Pill; Drug: Ritonavir; Drug: Itraconazole Testosterone Suppression of Participants as Assessed by Testosterone Levels; Decrease in Relugolix Levels; Reduction in Prostate-Specific Antigens Levels of Participants After Study Treatment; Rate of Reported Adverse Events Among Participants University of Chicago Male 18 Years and older (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment IRB22-1150 13/02/2023 04/01/2025 04/01/2025 01/11/2023 10/06/2023 https://ClinicalTrials.gov/show/NCT05679388 Localised/Locoregional Hospital/University/Research Institute Y Y N United States Urological Prostate Cancer Itraconazole; Ritonavir Biomarker Phase 1 DB00602; DB01656 N
NCT00859781 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer Active, not recruiting Prostate Cancer Drug: 177Lu-J591; Drug: Ketoconazole; Drug: Hydrocortisone; Drug: 111In-J591 Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration; Change in PSA Response Rate Weill Medical College of Cornell University; United States Department of Defense Male 18 Years and older (Adult, Older Adult) 55 Other; U.S. Fed Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 0810010067; J591+Ketoconazole 06/01/2009 02/10/2022 12/01/2025 03/11/2009 19/07/2023 19/07/2023 https://ClinicalTrials.gov/show/NCT00859781 Recurrent/Refractory Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Ketoconazole DFS/RFS/EFS Phase 2 DB01009 N
NCT03662412 Study of Sirolimus in Patients With Advanced Pancreatic Cancer Unknown status Pancreatic Cancer Drug: Sirolimus overall survival; Response rate Second Affiliated Hospital, School of Medicine, Zhejiang University All 18 Years to 80 Years (Adult, Older Adult) 36 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SAHZU-2018-064 06/01/2018 30/06/2023 30/06/2023 09/07/2018 09/07/2018 https://ClinicalTrials.gov/show/NCT03662412 Recurrent/Refractory Hospital/University/Research Institute N N N China GI Pancreatic Cancer Sirolimus OS Phase 1/2 DB01261 N
NCT01529593 Temsirolimus in Combination With Metformin in Patients With Advanced Cancers Active, not recruiting Advanced Cancers Drug: Temsirolimus; Drug: Metformin Maximum Tolerated Dose (MTD) of Temsirolimus and Metformin; Clinical Tumor Response M.D. Anderson Cancer Center All 14 Years and older (Child, Adult, Older Adult) 87 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2011-0923; NCI-2012-00216 26/03/2012 06/01/2024 06/01/2024 02/09/2012 10/06/2023 https://ClinicalTrials.gov/show/NCT01529593 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Metformin Safety and/or Dose Phase 1 DB00703 N
NCT03099356 Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer Recruiting Metastatic Thyroid Cancer Drug: Cyclophosphamide; Drug: Sirolimus Percentage of patients that respond to treatment; The number of patients that experience toxicity; Median overall survival time; Median progression free survival time University of Michigan Rogel Cancer Center All 18 Years and older (Adult, Older Adult) 19 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UMCC 2017.013; HUM00126559 27/04/2017 12/01/2023 12/01/2024 04/04/2017 31/08/2023 https://ClinicalTrials.gov/show/NCT03099356 Recurrent/Refractory Hospital/University/Research Institute N N N United States Endocrine Thyroid Cancer Sirolimus Response rate Phase 2 DB01261 N
NCT03458221 Signal TrAnsduction Pathway Activity Analysis in OVarian cancER STAPOVER Recruiting Recurrent Ovarian Cancer|Signal Transduction Pathway Deregulation|Therapy-Associated Cancer Drug: Letrozole Oral Product; Drug: Bicalutamide Oral Product; Drug: Everolimus Oral Product; Drug: Itraconazole Oral Product Progression free survival on matched targeted therapy determined by STP-activity (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1).; Proportion of patients with an actionable active pathway for which targeted therapy is recommended in relation to the number of patients who underwent a biopsy.; Proportion of patients who receive matched targeted therapy in relation to the number of patients included in each study arm.; Best overall response defined by RECIST 1.1 criteria based on radiological imaging.; One-year survival; Overall survival; Predictive value of STA-analysis results on matched targeted therapy response.; Side effects; Health Related Quality of Life; Cost-effectiveness; Change in pathway activity score after disease progression compared to pathway activity score before start of matched therapy. Gynaecologisch Oncologisch Centrum Zuid; Radboud University Medical Center; Erasmus Medical Center; Maastricht University Medical Center; InnoSIGN; Eurofins Female 18 Years and older (Adult, Older Adult) 148 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STAPOVER; 2020-005091-36 31/01/2023 10/01/2026 10/01/2026 03/08/2018 18/04/2023 https://ClinicalTrials.gov/show/NCT03458221 Palliative Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands Gynaecological Ovarian Epithelial Cancer Itraconazole PFS; OS; QoL; Biomarker Phase 3 DB00602 N
NCT04481100 CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer Unknown status Esophageal Neoplasm|Esophageal Diseases|Esophageal Squamous Cell Carcinoma Drug: itraconazole Objective response rate (ORR); Treatment-emergent adverse events; Local-regional free survival (LRFS); Overall survival (OS) Hangzhou Cancer Hospital All 18 Years to 75 Years (Adult, Older Adult) 38 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20200707 10/01/2020 31/07/2021 31/07/2023 22/07/2020 14/10/2020 https://ClinicalTrials.gov/show/NCT04481100 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N China GI Esophageal Cancer Itraconazole Safety and/or Dose; Response rate; OS; DFS/RFS/EFS Phase 2 DB00602 N
NCT03217669 Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy Active, not recruiting Advanced Solid Tumor|Non-small Cell Lung Cancer (NSCLC) Drug: Epacadostat; Drug: sirolimus Incidence of treatment-emergent adverse events.; Overall response response in subjects with NSCLC (dose expansion cohort); Disease control rate (DCR) >40 in subjects with NSCLC (dose expansion cohort); Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort); Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort) Chao Huang; University of Kansas Medical Center All 18 Years and older (Adult, Older Adult) 15 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IIT-2016-Epacadostat+SIRO 22/02/2018 04/01/2024 08/01/2025 14/07/2017 05/03/2023 https://ClinicalTrials.gov/show/NCT03217669 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types; Lung Any solid tumours; Non-Small Cell Lung Cancer Sirolimus Safety and/or Dose Phase 1 DB01261 N
NCT02875223 A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas Active, not recruiting Lymphoma, Non-Hodgkin|Neoplasms Drug: CC-90011; Drug: Rifampicin; Drug: Itraconazole Dose-Limiting Toxicity (DLT); Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria; Maximum observed plasma concentration (Cmax); Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0- ); AUC from time zero to the last quantifiable concentration (AUC0-t); Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria; Objective Response Rate (ORR); Progression-Free Survival (PFS); Overall Survival (OS); Duration of Response (DOR) Celgene All 18 Years and older (Adult, Older Adult) 91 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CC-90011-ST-001 31/08/2016 18/09/2025 18/09/2025 23/08/2016 12/08/2023 https://ClinicalTrials.gov/show/NCT02875223 Recurrent/Refractory Company N Y N France Multiple cancer types; Lymphoma; Leukemia Any solid tumours; Any lymphoma; Any leukemias Itraconazole; Rifampicin Safety and/or Dose Phase 1 DB00602; DB00740 N
NCT02584647 PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors PLX3397 Recruiting Sarcoma|Malignant Peripheral Nerve Sheath Tumors Drug: PLX3397; Drug: Sirolimus Maximum tolerated dose (MTD) - Phase 1; Progression free survival (PFS) rate - Phase 2; Overall survival rate Gulam Manji; Daiichi Sankyo, Inc.; Columbia University All 18 Years and older (Adult, Older Adult) 43 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AAAO6059; R01FD005745 11/04/2015 07/01/2023 03/01/2024 22/10/2015 21/02/2023 https://ClinicalTrials.gov/show/NCT02584647 Advanced/Metastatic Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma Other Soft Tissue Sarcoma; Any soft tissue sarcoma Sirolimus Safety and/or Dose; PFS Phase 1/2 DB01261 N
NCT03796273 Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases Recruiting Anatomic Stage IV Breast Cancer AJCC v8|Astrocytoma|Breast Carcinoma Metastatic in the Brain|Glioma|Invasive Breast Carcinoma|Oligodendroglioma|Prognostic Stage IV Breast Cancer AJCC v8|Recurrent Glioma Other: Best Practice; Drug: Ketoconazole tGLI1 activation signature 8 (t-GAS 8); tGLI1 pathway activation; Incidence of adverse events (AEs); Blood brain penetrance of ketoconazole in serum relative to enhancing brain tissue Wake Forest University Health Sciences; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 19 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00054587; NCI-2018-03087; CCCWFU 91118; P30CA012197 13/03/2019 05/01/2024 07/01/2024 01/08/2019 11/03/2023 https://ClinicalTrials.gov/show/NCT03796273 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N United States Breast; CNS Any Breast Cancer; Glioma Ketoconazole Biomarker Phase 1 DB01009 N
NCT02446431 Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence Metronomic Recruiting Solid Tumor Drug: Bevacizumab; Drug: Cyclophosphamide; Drug: Valproic Acid; Drug: Temsirolimus 5 year Event Free Survival; Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Site(s) of relapse; Composite Cost of Treatment; Fatigue scores on the PedsQL Fatigue Scale; Pain scores on the Present Functioning Scale; Quality of Life scores on the PedsQL Quality of Life Scale Miller Children's Women's Hospital Long Beach; Children's Hospital of Orange County All 12 Months to 31 Years (Child, Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention 1 07/01/2014 07/01/2024 07/01/2029 18/05/2015 18/05/2015 https://ClinicalTrials.gov/show/NCT02446431 Localised/Locoregional Hospital/University/Research Institute N N Y United States Bone Sarcoma; Soft Tissue Sarcoma Osteosarcoma; Ewing Sarcoma; Other Soft Tissue Sarcoma; Rhabdomyosarcoma Valproic Acid DFS/RFS/EFS Phase 1 DB00177 N
NCT05563766 A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer Not yet recruiting Esophageal Adenocarcinoma|Esophageal Squamous Cell Carcinoma|Gastroesophageal Junction Carcinoma Drug: Itraconazole Rate of pathological complete response with itraconazole; Comparison of Hedgehog, AKT, and angiogenesis pathway status before and after intervention; Correlation of peripheral blood and esophageal tissue levels of itraconazole and hydroxyitraconazole with pathologic response; Develop a predictive genomic profile of treatment response; Determine the utility of ctDNA and exosome characterization as a prognostic marker VA Office of Research and Development; Durham VA Health Care System; VA Palo Alto Health Care System; Portland VA Medical Center; VA Puget Sound Health Care System; Michael E. DeBakey VA Medical Center; VA Boston Healthcare System All 18 Years and older (Adult, Older Adult) 78 U.S. Fed Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ONCB-016-21F; I01CX002349 15/01/2024 14/01/2029 28/02/2029 10/03/2022 12/06/2023 https://ClinicalTrials.gov/show/NCT05563766 Localised/Locoregional Local/National government N N N United States GI Esophageal Cancer Itraconazole Response rate; Biomarker Phase 2 DB00602 N
NCT01552434 Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease Active, not recruiting Advanced Malignant Neoplasm|Castleman Disease|Digestive System Carcinoma|Erdheim-Chester Disease|Lip and Oral Cavity Carcinoma|Lymphangioleiomyomatosis|Malignant Endocrine Neoplasm|Malignant Female Reproductive System Neoplasm|Malignant Male Reproductive System Neoplasm|Malignant Neoplasm|Malignant Respiratory Tract Neoplasm|Malignant Thoracic Neoplasm|Malignant Urinary System Neoplasm|Mesothelial Neoplasm|Metastatic Malignant Neoplasm|Metastatic Urothelial Carcinoma|Neurofibromatosis Type 2|Recurrent Adult Soft Tissue Sarcoma|Recurrent Breast Carcinoma|Recurrent Childhood Soft Tissue Sarcoma|Recurrent Digestive System Carcinoma|Recurrent Female Reproductive System Carcinoma|Recurrent Male Reproductive System Carcinoma|Recurrent Malignant Neoplasm|Recurrent Pharyngeal Carcinoma|Recurrent Thyroid Gland Carcinoma|Refractory Malignant Neoplasm|Soft Tissue Neoplasm|Stage III Breast Cancer AJCC v7|Stage III Pharyngeal Cancer|Stage IIIA Breast Cancer AJCC v7|Stage IIIB Breast Cancer AJCC v7|Stage IIIC Breast Cancer AJCC v7|Stage IV Breast Cancer AJCC v6 and v7|Stage IV Pharyngeal Cancer|Stage IVA Pharyngeal Cancer|Stage IVB Pharyngeal Cancer|Stage IVC Pharyngeal Cancer|Thyroid Gland Neoplasm Biological: Bevacizumab; Biological: Cetuximab; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Temsirolimus; Drug: Valproic Acid Maximum tolerated dose (MTD) of bevacizumab, defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT); MTD of temsirolimus, defined as the dose level below the dose at which 2 of 6 patients experience DLT; Anti-tumor efficacy of each combination (objective response); Levels of surrogate anti-angiogenesis markers M.D. Anderson Cancer Center; National Cancer Institute (NCI) All Child, Adult, Older Adult 155 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2012-0061; NCI-2012-00347 16/03/2012 31/03/2024 31/03/2024 13/03/2012 09/07/2023 https://ClinicalTrials.gov/show/NCT01552434 Advanced/Metastatic Hospital/University/Research Institute Y Y N United States Multiple cancer types Any solid tumours Valproic Acid Safety and/or Dose Phase 1 DB00177 N
NCT05896839 Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer Recruiting Clinical Stage III Cutaneous Melanoma AJCC v8|Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8|Clinical Stage IV Cutaneous Melanoma AJCC v8|Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8|Metastatic Basal Cell Carcinoma|Metastatic Carcinoma in the Skin|Metastatic Melanoma|Metastatic Merkel Cell Carcinoma|Metastatic Skin Squamous Cell Carcinoma|Unresectable Basal Cell Carcinoma|Unresectable Melanoma|Unresectable Merkel Cell Carcinoma|Unresectable Skin Squamous Cell Carcinoma Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Ipilimumab; Procedure: Kidney Biopsy; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Drug: Prednisone; Drug: Sirolimus Disease control without allograft loss; Objective response rate (ORR); Rate of allograft loss and rejection; Duration of response (DOR) among patients who experience CR or PR; Progression-free survival (PFS); Overall survival National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 16 NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2023-04306; 10614; UM1CA186691 08/11/2024 31/01/2027 31/01/2027 06/09/2023 01/03/2024 https://ClinicalTrials.gov/show/NCT05896839 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Basal Cell Carcinoma; Melanoma; Merkel Cell Carcinoma; Other skin cancer Sirolimus Response rate; PFS; OS; Other (specify) Phase 1/2 DB01261 N
NCT04771130 A Study of BGB-11417 in Participants With Myeloid Malignancies Recruiting Acute Myeloid Leukemia|Myelodysplastic Syndromes|Myelodysplastic/Myeloproliferative Neoplasm Drug: BGB-11417; Drug: Azacitidine; Drug: Posaconazole Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs); Part 1 And 2: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing Treatment-emergent Adverse Events (TEAEs); Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate; Part 3 MDS Cohort: Modified Overall Response (mOR) Rate; Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable (AUC0-t) Of BGB-11417 When Co-administered With Posaconazole; Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Coadministered With Posaconazole; Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Co-administered With Posaconazole; Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs; Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs; Parts 1 And 2 AML Cohort: CR Plus CRh Rate; Parts 1 And 2 MDS Cohort: mOR Rate; Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: t1/2 Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: Apparent Volume Of Distribution (Vz/F) Of Azacitidine When Coadministered With BGB-11417; Parts 1 And 2: Steady-state AUC From Time Zero To Time Of Last Measurable Concentration (AUClast,ss) Of BGB-11417 When Coadministered With Azacitidine; Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine; Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine; Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine; Part 3: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing TEAEs; Part 3: Complete Response; Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate; Part 3 AML Cohort: Overall Response Rate (ORR); Part 3 AML Cohort: Duration Of Response (DOR); Part 3 AML Cohort: Time To Response (TTR); Part 3 AML Cohort: Event-free Survival (EFS); Part 3 AML Cohort: Overall Survival (OS); Part 3 AML Cohort: Number Of Participants Receiving BGB-11417 In Combination With Posaconazole Experiencing TEAEs; Part 3 AML Cohort: Number of Participants with Transfusion Independence; Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E); Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P); Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N); Part 3 MDS Cohort: Number of participants with Transfusion Independence; Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine; Part 3 MDS cohort: Partial Hematologic Recovery CRh; Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery; Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417; Part 3 MDS (Treated with Monotherapy): Modified Overall Response; Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417 BeiGene All 18 Years and older (Adult, Older Adult) 260 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BGB-11417-103; 2021-003285-12 24/05/2021 12/01/2023 08/01/2025 25/02/2021 19/10/2023 https://ClinicalTrials.gov/show/NCT04771130 Localised/Locoregional; Recurrent/Refractory Company Y N N Australia Leukemia; Other Haem-onc Acute Lymphoblastic Leukemia, Adult; Myelodysplastic Syndromes Posaconazole Safety and/or Dose; Response rate Phase 1/2 DB00175 N
NCT03763396 Azoles Targeting Recurrent High Grade Gliomas Unknown status Brain Tumor, Recurrent|Cancer, Advanced|Glioma of Brain Drug: Ketoconazole (KCZ); Drug: Posaconazole (PCZ) Intratumoral concentrations of KCZ or PCZ; Plasma concentrations of KCZ or PCZ; Assess Hexokinase 2 activity; Assess the biological effects of KCZ or PCZ on metabolites within the glycolytic pathway; assess the biological effects of KCZ or PCZ on tumor proliferation; assess biological effects of KCZ or PCZ on tumor cell death; assess biological effects of KCZ or PCZ on tumor angiogenesis University Health Network, Toronto All 18 Years and older (Adult, Older Adult) 30 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other 18-5097 08/01/2019 08/01/2022 08/01/2022 12/04/2018 04/01/2021 https://ClinicalTrials.gov/show/NCT03763396 Recurrent/Refractory Hospital/University/Research Institute N Y N Canada CNS Glioma Ketoconazole; Posaconazole Other (specify) Phase 1 DB01009; DB00175 N
NCT04813653 Cyclosporine in Combination With Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma Refractory to Carfilzomib and High Expression of PPIA Gene in Myeloma Cells Recruiting Multiple Myeloma in Relapse|Multiple Myeloma, Refractory Drug: cyclosporine in combination with carfilzomib and dexamethasone Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment parameters.; Overall response rate ORR; Progression free survival PFS; Duration of Response DOR; Time to Response TTR; Depth of Best Response (DpR); Time to progression (TTP); Overall Survival (OS); Extramedullary progression; Percentage of cyclosporine trough levels tests in acceptable range; Mean of levels in acceptable range will be calculated for the efficacy population. Tel-Aviv Sourasky Medical Center; Weizmann Institute of Science All 18 Years and older (Adult, Older Adult) 10 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1007-20-TLV 18/04/2021 04/01/2024 05/01/2024 24/03/2021 21/04/2023 https://ClinicalTrials.gov/show/NCT04813653 Recurrent/Refractory Hospital/University/Research Institute N N N Israel Other Haem-onc Multiple Myeloma Cyclosporine Safety and/or Dose Phase 1 DB00434 N
NCT02675452 AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia Active, not recruiting Relapsed or Refractory Multiple Myeloma|Relapsed or Refractory Acute Myeloid Leukemia Drug: AMG 176; Drug: Azacitidine; Drug: Itraconazole Multiple Myeloma (MM) Part 1a Incidence of dose-limiting toxicities (DLTs); MM Part 1a Incidence of treatment-related adverse events; MM Part 1a Incidence of treatment-emergent adverse events; MM Part 1a Incidence of clinically significant changes in vital signs; MM Part 1a Incidence of clinically significant changes in electrocardiograms (ECGs); MM Part 1a Incidence of clinically significant changes in clinical laboratory tests; MM Part 1a Pharmacokinetic (PK) parameters for AMG 176: maximum observed concentration (Cmax); MM Part 1a Pharmacokinetic parameters for AMG 176: area under the concentration-time curve (AUC); MM Part 1a Pharmacokinetic parameters for AMG 176: clearance (CL); MM Part 1a Pharmacokinetic parameters for AMG 176: half-life (t1/2); MM Part 1b Incidence of DLTs; MM Part 1b Incidence of treatment-related adverse events; MM Part 1b Incidence of treatment-emergent adverse events; MM Part 1b Incidence of clinically significant changes in vital signs; MM Part 1b Incidence of clinically significant changes in ECGs; MM Part 1b Incidence of clinically significant changes in clinical laboratory tests; MM Part 1b Pharmacokinetic parameters for AMG 176: Cmax; MM Part 1b Pharmacokinetic parameters for AMG 176: AUC; MM Part 1b Pharmacokinetic parameters for AMG 176: CL; MM Part 1b Pharmacokinetic parameters for AMG 176: t1/2; Acute Myeloid Leukemia (AML) Part 3a Incidence of DLTs; AML Part 3a Incidence of treatment-related adverse events; AML Part 3a Incidence of treatment-emergent adverse events; AML Part 3a Incidence of clinically significant changes in vital signs; AML Part 3a Incidence of clinically significant changes in ECGs; AML Part 3a Incidence of clinically significant changes in clinical laboratory tests; AML Part 3a Pharmacokinetic parameters for AMG 176: Cmax; AML Part 3a Pharmacokinetic parameters for AMG 176: AUC; AML Part 3a Pharmacokinetic parameters for AMG 176: CL; AML Part 3a Pharmacokinetic parameters for AMG 176: t1/2; AML Part 3b Incidence of DLTs; AML Part 3b Incidence of treatment-related adverse events; AML Part 3b Incidence of treatment-emergent adverse events; AML Part 3b Incidence of clinically significant changes in vital signs; AML Part 3b Incidence of clinically significant changes in ECGs; AML Part 3b Incidence of clinically significant changes in clinical laboratory tests; AML Part 3b Pharmacokinetic parameters for AMG 176: Cmax; AML Part 3b Pharmacokinetic parameters for AMG 176: AUC; AML Part 3b Pharmacokinetic parameters for AMG 176: CL; AML Part 3b Pharmacokinetic parameters for AMG 176: t1/2; AML Part 3c Incidence of DLTs; AML Part 3c Incidence of treatment-related adverse events; AML Part 3c Incidence of treatment-emergent adverse events; AML Part 3c Incidence of clinically significant changes in vital signs; AML Part 3c Incidence of clinically significant changes in ECGs; AML Part 3c Incidence of clinically significant changes in clinical laboratory tests; AML Part 3c Pharmacokinetic parameters for AMG 176: Cmax; AML Part 3c Pharmacokinetic parameters for AMG 176: AUC; AML Part 3c Pharmacokinetic parameters for AMG 176: CL; AML Part 3c Pharmacokinetic parameters for AMG 176: t1/2; AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: Cmax; AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: AUC; AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: CL; AML Part 3d Pharmacokinetic parameters for AMG 176 and itraconazole: t1/2; AML Part 4 Incidence of DLTs; AML Part 4 Incidence of treatment-related adverse events; AML Part 4 Incidence of treatment-emergent adverse events; AML Part 4 Incidence of clinically significant changes in vital signs; AML Part 4 Incidence of clinically significant changes in ECGs; AML Part 4 Incidence of clinically significant changes in clinical laboratory tests; AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax; AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC; AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: CL; AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2; AML Part 5 Incidence of treatment-related adverse events; AML Part 5 Incidence of treatment-emergent adverse events; AML Part 5 Incidence of clinically significant changes in vital signs; AML Part 5 Incidence of clinically significant changes in ECGs; AML Part 5 Incidence of clinically significant changes in clinical laboratory tests; AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: Cmax; AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: AUC; AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: CL; AML Part 5 Pharmacokinetic parameters for AMG 176 and azacitidine: t1/2; MM Part 1a Overall response (OR) according to International Myeloma Working Group uniform response criteria (IMWG-URC) for MM subjects; MM Part 1a Progression-free survival (PFS); MM Part 1a Time to response; MM Part 1a Duration of response (DOR); MM Part 1a BAX and caspase 3 expression in circulating monocytes Amgen All 18 Years to 85 Years (Adult, Older Adult) 142 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20150161; 2015-004777-32 13/06/2016 29/01/2024 25/07/2024 02/05/2016 15/12/2023 https://ClinicalTrials.gov/show/NCT02675452 Recurrent/Refractory Company N Y N United States Leukemia; Other Haem-onc Acute Myeloid Leukemia, Adult; Multiple Myeloma Itraconazole Safety and/or Dose Phase 1 DB00602 N
NCT03972748 Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin. Unknown status Basal Cell Carcinoma|Hedgehog Pathway Drug: Itraconazole 200 mg clinical response; hedgehog pathway activity Hospital de Clinicas de Porto Alegre All 18 Years and older (Adult, Older Adult) 28 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 47011715.0.0000.5327 01/05/2018 12/01/2020 06/01/2021 06/04/2019 06/04/2019 https://ClinicalTrials.gov/show/NCT03972748 Localised/Locoregional Hospital/University/Research Institute N N N Brazil Skin Basal Cell Carcinoma Itraconazole Response rate Other DB00602 N
NCT05324384 Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma Recruiting Hemangioendothelioma Drug: Sirolimus The changes in KHE volume; Quality of life (QOL) in patients; Frequency of adverse events; The changes in the patient's musculoskeletal complication.; The changes of platelet counts.; The changes of fibrinogen levels.; The changes of D-dimer levels. West China Hospital All up to 14 Years (Child) 30 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 2022-405 04/05/2022 30/04/2025 30/11/2025 04/12/2022 05/06/2022 https://ClinicalTrials.gov/show/NCT05324384 Localised/Locoregional Hospital/University/Research Institute N N Y China Other Other Sirolimus Safety and/or Dose; QoL; Biomarker Phase 2 DB01261 N
NCT01869114 Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy Active, not recruiting Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities|Adult Acute Myeloid Leukemia With Del(5q)|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)|Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)|de Novo Myelodysplastic Syndromes|Myelodysplastic Syndrome With Isolated Del(5q)|Previously Treated Myelodysplastic Syndromes|Recurrent Adult Acute Myeloid Leukemia Drug: Sirolimus; Drug: Azacitidine Rate of response; Toxicity referring to toxic events during the full course of treatment that are attributed as possibly, probably or definitely due to treatment, graded according to the National Institutes of Health (NIH) Common Toxicity Criteria (CTC) v. 4.0; Pharmacokinetic assessment to assess levels of the drug in vivo; Inhibition of mTOR signaling by sirolimus measured by intracellular flow cytometry for phosphorylation of the downstream signaling target S6 ribosomal protein as a surrogate for mTOR activity; Quality of life (QOL) assessed by the European Organization for Research and Treatment of Cancer (EORTC) QOL and the Mental Health Inventory (MHI) Sidney Kimmel Cancer Center at Thomas Jefferson University; Thomas Jefferson University All 18 Years and older (Adult, Older Adult) 57 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 12D.587; 2012-50 07/08/2013 12/01/2023 12/01/2023 06/05/2013 06/07/2023 https://ClinicalTrials.gov/show/NCT01869114 Any/All Stages Hospital/University/Research Institute N N N United States Leukemia Acute Myeloid Leukemia, Adult Sirolimus Response rate Phase 2 DB01261 N
NCT05284552 Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer Recruiting Epithelial Ovarian Cancer Drug: Tinzaparin Injectable Solution Changes in serum levels of CA-125; Changes in blood levels of hemoglobin; Changes in blood levels of platelets; Changes in blood levels of leucocytes; Changes in plasma levels of CRP; Changes in plasma levels of albumin; Changes in plasma levels of interleukin 6; Changes in plasma levels of vascular endothelial growth factor; Self reported compliance to tinzaparin injections; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0; Objectively confirmed venous thromboembolism (VTE), i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE. University Hospital, Linkoeping; Region J nk ping County; V stervik Hospital Female 18 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment The TABANETOC-trial; 2021-000135-31 07/12/2022 31/12/2024 31/12/2024 17/03/2022 28/04/2023 https://ClinicalTrials.gov/show/NCT05284552 Localised/Locoregional Hospital/University/Research Institute N N N Sweden Gynaecological Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Endometrial Cancer Tinzaparin Safety and/or Dose; Biomarker Phase 2 DB01007 N
NCT05178628 The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer imPaCT-PRO Recruiting Pancreatic Cancer|Thromboembolism Drug: Innohep; Drug: Chemotherapy: Gemcitabine + Nab-Paclitaxel PFS of patients; The number of VTE events during the trial; of patients experiencing at least one major bleeding event; of patients experiencing any bleeding event; VTE events; Patients with complete or partial response; Change from baseline in QoL Michalis Karamouzis; Institute of Molecular Medicine and Biomedical Research All 18 Years and older (Adult, Older Adult) 450 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention imPaCT-PRO-01 02/10/2022 31/12/2024 31/12/2024 01/05/2022 29/03/2022 https://ClinicalTrials.gov/show/NCT05178628 Primary/Main Curative Advanced/Metastatic Hospital/University/Research Institute Y N N Greece GI Pancreatic Cancer Tinzaparin PFS; Other (specify) Phase 3 DB01007 N
NCT05521984 Targeting Pediatric Brain Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i) Recruiting Pediatric Brain Tumor Drug: Dapagliflozin; Drug: Carmustine Number and type of adverse events experienced by participants; Change in blood glucose; Change in ketones; Change in HbA1c; Tumor response rate; Feasibility of regimen; Changes in fructosamine; Changes in c-peptide; Changes in glucagon Washington University School of Medicine; Children's Discovery Institute All 6 Years to 21 Years (Child, Adult) 20 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 202210013 04/03/2023 31/08/2026 30/11/2026 30/08/2022 04/06/2023 https://ClinicalTrials.gov/show/NCT05521984 Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS Any CNS cancers Dapagliflozin Safety and/or Dose; Response rate; Biomarker Phase 1 DB00250 N
NCT03889795 Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors Recruiting Advanced Pancreatic Cancer|Advanced Solid Tumor Drug: Metformin; Drug: Simvastatin; Drug: Digoxin Maximum Tolerated Dose and/or Recommended Dose within the tested C3 dose range; Safety and Tolerability: Occurrence of treatment - emergent adverse events (TEAEs) and other abnormalities; Efficacy (Disease Response); Assess BIRC5 levels of expression in tumor tissue; Assess molecular changes induced by C3 administration in the blood for biomarker sensitivity/resistance assessment Danae Hamouda, MD; University of Toledo All 18 Years and older (Adult, Older Adult) 15 Other Interventional Study Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment C3 06/05/2019 30/12/2024 30/12/2025 26/03/2019 09/01/2023 https://ClinicalTrials.gov/show/NCT03889795 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Digoxin; Metformin; Simvastatin Safety and/or Dose Phase 1 DB08908; DB00703; DB00877 N
NCT04141995 FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer Recruiting Pancreas Cancer|Adenocarcinoma of the Pancreas Drug: Digoxin; Drug: 5Fluorouracil; Drug: Calcium Leucovorin; Drug: Irinotecan; Drug: Oxaliplatin Number of patients able to undergo resection surgery; Percentage of subjects with grade 4 thrombocytopenia and grade 3-4 diarrhea University of Nebraska; National Cancer Institute (NCI) All 19 Years and older (Adult, Older Adult) 20 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 0668-19-FB; 1P50CA127297-01A2 02/12/2021 02/01/2025 02/01/2025 28/10/2019 10/03/2023 https://ClinicalTrials.gov/show/NCT04141995 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Digoxin Other (specify) Phase 2 DB08908 N
NCT05507775 Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma DIGUP-TC Active, not recruiting Non-Medullary Thyroid Carcinoma Drug: Digoxin tablet Reinduction of radioiodine uptake in target lesion; Beneficial effects of high-dose radioactive iodine treatment after reinduction; Safety of digoxin treatment Radboud University Medical Center All 18 Years and older (Adult, Older Adult) 10 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2022-500477-14-00 12/06/2022 21/06/2023 01/01/2024 19/08/2022 08/04/2023 https://ClinicalTrials.gov/show/NCT05507775 Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands Endocrine Thyroid Cancer Digoxin Safety and/or Dose; Biomarker Other DB08908 N
NCT03076281 Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery Active, not recruiting Larynx|LIP|Oral Cavity|Pharynx Drug: Metformin Hydrochloride; Drug: Doxycycline; Drug: Metformin +Doxycycline Change in percent of CFS expressing CAV-1 at an intensity of 1+ or greater assessed in tumor-associated stroma cells by immunohistochemistry (IHC); Incidence of adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0; Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express BGAL; Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express MCT1; Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express MCT4; Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express TOMM20 Sidney Kimmel Cancer Center at Thomas Jefferson University; Thomas Jefferson University All 18 Years and older (Adult, Older Adult) 7 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 16D.703 04/03/2017 12/03/2018 08/01/2020 03/10/2017 24/12/2018 https://ClinicalTrials.gov/show/NCT03076281 Localised/Locoregional Hospital/University/Research Institute N Y N United States Head and Neck Any head and neck squamous cell carcinoma Doxycycline; Metformin Safety and/or Dose; Biomarker Phase 2 DB04855; DB00703 N
NCT01820910 Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment Active, not recruiting Marginal Zone Lymphoma of Ocular Adnexal Drug: Doxycycline progression-free survival (PFS) International Extranodal Lymphoma Study Group (IELSG) All 18 Years and older (Adult, Older Adult) 34 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IELSG39 03/01/2013 05/01/2016 09/01/2023 29/03/2013 18/05/2023 https://ClinicalTrials.gov/show/NCT01820910 Localised/Locoregional Collaborative Group N N N United States Lymphoma Lymphoma - Other Doxycycline PFS Phase 2 DB04855 N
NCT03116659 CTCL Directed Therapy Unknown status Lymphoma, T-Cell, Cutaneous Drug: Doxycycline; Drug: Imiquimod Pilot assessment of response. James J. Peters Veterans Affairs Medical Center All 30 Years to 89 Years (Adult, Older Adult) 8 U.S. Fed Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment DAN-15-028 02/01/2018 30/12/2020 30/12/2020 17/04/2017 13/08/2019 https://ClinicalTrials.gov/show/NCT03116659 Localised/Locoregional Hospital/University/Research Institute N N N United States Lymphoma Cutaneous T-Cell Lymphoma Doxycycline Response rate Phase 1 DB04855 N
NCT03603795 Study Impact on Outcome of Eltrombopag in Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy EPAG2015 Active, not recruiting Acute Myeloid Leukemia Drug: Eltrombopag; Drug: Placebo Overal survival rate; Response rate (CR and CRi) at day 45; Leukemia Free Survival at month 12 (one year); Long-term survival; Percentage of patients with platelets count > 100 Giga/L at day 45; Time to platelet transfusion independence French Innovative Leukemia Organisation; Novartis Pharmaceuticals All 60 Years and older (Adult, Older Adult) 110 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment EPAG 2015 10/11/2018 15/06/2022 09/01/2024 27/07/2018 26/09/2022 https://ClinicalTrials.gov/show/NCT03603795 Localised/Locoregional Collaborative Group Y N N France Leukemia Acute Myeloid Leukemia, Adult Eltrombopag Response rate; OS Phase 2 DB13393 N
NCT04011410 Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer Active, not recruiting Prostate Cancer Recurrent Drug: Hydroxychloroquine Sulfate 200Mg Tab Change in Prostate Apoptosis Response-4 (PAR-4) Levels; Change in Serum Prostate Specific Antigen (PSA) Levels; Progression-Free Survival; Androgen Deprivation Therapy (ADT)-Free Survival Patrick Hensley; University of Kentucky Male 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 50146 - MCC-19-GU-72 12/03/2019 03/01/2024 18/11/2026 07/08/2019 12/11/2023 https://ClinicalTrials.gov/show/NCT04011410 Advanced/Metastatic Hospital/University/Research Institute N N N United States Urological Prostate Cancer Hydroxychloroquine Biomarker Phase 2 DB07118 N
NCT03037437 Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer Recruiting Hepatocellular Cancer Drug: Sorafenib (SOR); Drug: Hydroxychloroquine (HCQ) Time to tumor progression evaluated via tumor imaging The University of Texas Health Science Center at San Antonio All 18 Years to 100 Years (Adult, Older Adult) 68 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CTMS 16-0076; HSC20160515H 16/02/2017 03/01/2024 03/01/2025 31/01/2017 07/03/2023 https://ClinicalTrials.gov/show/NCT03037437 Advanced/Metastatic Hospital/University/Research Institute N Y N United States GI Liver Cancer Hydroxychloroquine PFS Phase 2 DB07118 N
NCT05083780 Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer Active, not recruiting Pancreatic Cancer Drug: Chlorphenesin Carbamate, Hydroxychloroquine Number of participants with treatment-related adverse events assessed by CTCAE v5.0; Rate of Progression-Free Survival; Rate of Distant Metastasis-Free Survival; Overall Survival; Objective Response Rate Changhoon Yoo; Oncocross Co. Ltd.; CytoGen, Inc.; Asan Medical Center All 19 Years to 79 Years (Adult, Older Adult) 40 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OC-201/202-001 30/11/2021 30/04/2024 12/01/2024 19/10/2021 19/07/2023 https://ClinicalTrials.gov/show/NCT05083780 Advanced/Metastatic Company N N N Korea, Republic of GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS Phase 1 DB07118 N
NCT04523857 ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer ABBY Recruiting Breast Cancer Drug: Abemaciclib; Drug: Hydroxychloroquine Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema); Change in bone marrow DTC number evaluated by DTC-IHC assay after 6 cycles of therapy compared to baseline (Efficacy of Abema +/- HCQ in eliminating bone marrow DTCs) Abramson Cancer Center at Penn Medicine All 18 Years and older (Adult, Older Adult) 66 Other Interventional Study Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UPCC 10119 11/01/2021 12/01/2027 12/01/2028 24/08/2020 01/10/2023 https://ClinicalTrials.gov/show/NCT04523857 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Hydroxychloroquine Biomarker Phase 2 DB07118 N
NCT05518110 PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer PaTcH Recruiting Pancreatic Cancer Drug: Trametinib; Drug: Hydroxychloroquine Patients free of disease progression; Tumour Response Rate; Duration of Response; Overall Survival; Safety and tolerability Cancer Trials Ireland; Novartis All 18 Years and older (Adult, Older Adult) 22 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CTRIAL-IE 20-27; 2021-006276-16 31/05/2023 15/07/2024 15/04/2025 26/08/2022 18/06/2023 https://ClinicalTrials.gov/show/NCT05518110 Advanced/Metastatic; Recurrent/Refractory Collaborative Group N N N Ireland GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS Phase 2 DB07118 N
NCT05576896 Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory Recruiting Stage IV Colorectal Cancer Positive for BRAF V600E Mutation|Colorectal Cancer|Colorectal Cancer Stage IV Drug: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab Objective Response Rate (ORR); Progression-Free Survival (PFS); Overall Survival (OS); Duration of Response (DoR); Duration of Stable Disease (DoSD); Adverse Events Northwestern University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 43 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NU 22I05; Northwestern University; IRB#; P30CA060553; NCI-2022-08532 10/10/2022 07/01/2024 07/01/2025 13/10/2022 18/11/2022 https://ClinicalTrials.gov/show/NCT05576896 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS Phase 2 DB07118 N
NCT04132505 Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer Recruiting Metastatic Pancreatic Adenocarcinoma|Stage IV Pancreatic Cancer AJCC v8 Drug: Binimetinib; Drug: Hydroxychloroquine Maximum tolerated dose (MTD); Response rate; Incidence of adverse events; Progression free survival; Overall survival M.D. Anderson Cancer Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 39 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019-0191; NCI-2019-04991 22/10/2019 31/12/2023 31/12/2023 18/10/2019 22/11/2023 https://ClinicalTrials.gov/show/NCT04132505 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose Phase 1 DB07118 N
NCT05221320 Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies Recruiting Tumor, Solid|Gastrointestinal Cancer Drug: Ulixertinib; Drug: Hydroxychloroquine Overall response rate as defined by the proportion of patients achieving a confirmed partial response (PR) and complete response (CR) (defined by response evaluation criteria in solid tumors (RECIST 1.1) as evaluated by the local treating investigator.; The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NCI CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.; Progression-free survival (PFS) as defined as the time from study drug initiation to the time of documented disease progression (as assessed by RECIST 1.1) or death from any cause. BioMed Valley Discoveries, Inc All 18 Years and older (Adult, Older Adult) 215 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BVD-523-HCQ 26/05/2022 03/06/2024 19/06/2024 02/02/2022 16/05/2023 https://ClinicalTrials.gov/show/NCT05221320 Advanced/Metastatic Company N Y N United States GI Any GI cancer Hydroxychloroquine Response rate Phase 2 DB07118 N
NCT04386057 LY3214996 +/- HCQ in Pancreatic Cancer Active, not recruiting Pancreatic Cancer|Advanced Cancer Drug: Hydroxychloroquine Sulfate; Drug: LY3214996 Disease control rate (DCR); Dose Limiting Toxicity-Lead In; Objective response rate (ORR); Progression-free survival (PFS); Overall survival (OS) Kimberly Perez, MD; Eli Lilly and Company; Dana-Farber Cancer Institute All 18 Years and older (Adult, Older Adult) 52 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 19-529 27/05/2020 08/09/2023 02/09/2024 13/05/2020 11/08/2023 https://ClinicalTrials.gov/show/NCT04386057 Advanced/Metastatic Hospital/University/Research Institute Y N N United States GI Pancreatic Cancer Hydroxychloroquine Response rate Phase 2 DB07118 N
NCT04214418 Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies MEKiAUTO Active, not recruiting Gastrointestinal Cancer Drug: Cobimetinib; Drug: Hydroxychloroquine; Drug: Atezolizumab Phase 1: Estimated maximum tolerated dose (MTD); Phase 1: Incidence of Treatment-Emergent Adverse Events with drug combination (Safety and Tolerability) Columbia University; Genentech, Inc. All 18 Years and older (Adult, Older Adult) 175 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AAAS4165; ML41472 02/12/2020 06/01/2024 09/01/2024 01/02/2020 12/01/2022 https://ClinicalTrials.gov/show/NCT04214418 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Multiple cancer types; GI Multiple cancer types; Pancreatic Cancer; Colon Cancer; Rectal Cancer Hydroxychloroquine Safety and/or Dose Phase 1/2 DB07118 N
NCT03774472 Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer Active, not recruiting Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage IA Breast Cancer AJCC v8|Anatomic Stage IB Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage IIA Breast Cancer AJCC v8|Anatomic Stage IIB Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Anatomic Stage IV Breast Cancer AJCC v8|Prognostic Stage I Breast Cancer AJCC v8|Prognostic Stage IA Breast Cancer AJCC v8|Prognostic Stage IB Breast Cancer AJCC v8|Prognostic Stage IIA Breast Cancer AJCC v8|Prognostic Stage IIB Breast Cancer AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8|Prognostic Stage IV Breast Cancer AJCC v8 Drug: Hydroxychloroquine; Drug: Letrozole; Drug: Palbociclib Incidence of adverse events (Phase I); Change in breast tumor proliferation index (Ki67) (Phase II, Part I); Change in autophagy (Phase II, Part I); Change in senescence (Phase II, Part I); Change in cell cycle control (Phase II, Part I); Change in proportion of patients achieving tumoral complete cell cycle arrest (Phase II, Part II); Longer term clinical tumor responsiveness (tumor volume) (Phase II Part I); Tumor biomarker indices (for patients who have extended pre-operative therapy, maximum 24 weeks) (Phase II Part I and II); Blood-based tumor protein, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) biomarkers (Phase II Part I and II); Breast tumor indices of proliferation, autophagy, senescence, cell cycle control and other intersecting pathways (Phase II Part II); Dose responsiveness hydroxychloroquine (400 mg versus recommended phase 2 dose) (Phase II Part II) M.D. Anderson Cancer Center Female 18 Years and older (Adult, Older Adult) 15 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2017-0071; NCI-2018-01050 20/08/2018 31/12/2025 31/12/2025 13/12/2018 18/11/2023 https://ClinicalTrials.gov/show/NCT03774472 Localised/Locoregional Hospital/University/Research Institute N N N United States Breast Breast Cancer - ER/HR+; Breast Cancer - HER2- Hydroxychloroquine Safety and/or Dose; Biomarker Phase 1/2 DB07118 N
NCT04524702 Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer Active, not recruiting Advanced Pancreatic Adenocarcinoma|Metastatic Pancreatic Adenocarcinoma|Stage IV Pancreatic Cancer AJCC v8 Drug: Gemcitabine; Drug: Hydroxychloroquine; Drug: Nab-paclitaxel; Drug: Paricalcitol Change from baseline tumor size as measured by cross sectional imaging at 8 weeks.(every 8 weeks); Incidence of adverse events; Progression-free survival; Overall survival Emory University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 12 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00000996; NCI-2020-05417; Winship5079-20; P30CA138292 14/09/2020 14/08/2024 14/08/2024 24/08/2020 01/11/2024 https://ClinicalTrials.gov/show/NCT04524702 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine; Paricalcitol Response rate Phase 2 DB07118; DB00715 N
NCT03825289 Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer THREAD Recruiting Metastatic Pancreatic Carcinoma|Stage II Pancreatic Cancer|Stage IIA Pancreatic Cancer|Stage IIB Pancreatic Cancer|Stage III Pancreatic Cancer|Stage IV Pancreatic Cancer|Unresectable Pancreatic Carcinoma Drug: Hydroxychloroquine; Drug: Trametinib Rate of dose-limiting toxicities during the DLT assessment window.; Incidence of adverse events (AEs) for the duration of study treatment; Response Rate University of Utah; Novartis Pharmaceuticals All 18 Years and older (Adult, Older Adult) 39 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCI116898 18/01/2019 18/01/2024 18/01/2025 31/01/2019 07/05/2023 https://ClinicalTrials.gov/show/NCT03825289 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose Phase 1 DB07118 N
NCT05843188 Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer Recruiting Metastatic Colorectal Cancer Drug: Hydroxychloroquine; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab Overall response rate; Progression-free survival; Overall survival; Incidences and severity of adverse events University Health Network, Toronto All 18 Years and older (Adult, Older Adult) 155 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Targeting DTP in mCRC 08/09/2023 24/04/2026 24/10/2026 05/06/2023 21/08/2023 https://ClinicalTrials.gov/show/NCT05843188 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Colon Cancer; Rectal Cancer Hydroxychloroquine Response rate Phase 2 DB07118 N
NCT01480154 Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer Active, not recruiting Advanced Malignant Solid Neoplasm|Stage III Cutaneous Melanoma AJCC v7|Stage III Prostate Cancer AJCC v7|Stage III Renal Cell Cancer AJCC v7|Stage IIIA Cutaneous Melanoma AJCC v7|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7|Stage IV Prostate Cancer AJCC v7|Stage IV Renal Cell Cancer AJCC v7 Drug: Akt Inhibitor MK2206; Drug: Hydroxychloroquine Maximum tolerated dose of Akt inhibitor MK-2206; Dose-limiting toxicity rate; Changes in expression pattern of markers Beclin1, LC3, and p62; Change in autophagy activity induced by hydroxychloroquine; Validation of Beclin1, LC3, and p62 as markers for autophagy National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 62 NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2012-00084; 051105; CDR0000717546; CINJ-051105; 8983; P30CA072720; U01CA132194; UM1CA186716 23/11/2011 14/02/2020 28/11/2011 25/10/2023 https://ClinicalTrials.gov/show/NCT01480154 Advanced/Metastatic Local/National government N N N United States Multiple cancer types; Urological; Skin Multiple cancer types; Renal Cell Carcinoma; Prostate Cancer; Melanoma Hydroxychloroquine Safety and/or Dose Phase 1 DB07118 N
NCT04873895 TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) TACE-Ax-HCQ Recruiting Colorectal Neoplasms Malignant Drug: Axitinib 5 MG; Drug: Hydroxychloroquine Pill; Procedure: trans arterial chemoembolization Serious adverse event (SAE) rate; objective response rate in the liver; Hepatic progression-free survival; Progression-free survival; Overall survival; axitinib treatment intensity Abramson Cancer Center at Penn Medicine; Pfizer All 18 Years and older (Adult, Older Adult) 25 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UPCC03221 24/01/2022 07/01/2024 12/01/2024 05/05/2021 26/09/2023 https://ClinicalTrials.gov/show/NCT04873895 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS Phase 1 DB07118 N
NCT05365893 PHL Treatment in Pancreatic Cancer Recruiting Pancreatic Ductal Adenocarcinoma Combination Product: Paricalcitol, Hydroxychloroquine, Losartan; Other: Neoadjuvant therapy and surgery only (Control) Number of participants who experience grade 3 or greater treatment-related adverse events assessed by CTCAE v5.0 Fox Chase Cancer Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 20 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20-1085; GI-174; 1R21CA252535-01A1 20/10/2021 31/03/2024 31/12/2024 05/09/2022 26/06/2023 https://ClinicalTrials.gov/show/NCT05365893 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine; Losartan; Paricalcitol Safety and/or Dose Phase 1 DB07118; DB00227; DB00715 N
NCT04145297 Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas UTAH Active, not recruiting Gastrointestinal Neoplasms Drug: Ulixertinib; Drug: Hydroxychloroquine Recommended phase 2 dose of ulixertinib in combination with a fixed dose of hydroxychloroquine in subjects with advanced, RAS, non-V600 BRAF, ERK or MEK mutated gastrointestinal malignancies; Safety and tolerability of ulixertinib and hydroxychloroquine in the study population: adverse events (AEs) and serious adverse events (SAEs); Efficacy of ulixertinib and hydroxychloroquine in the study population: Objective response rate (PR and CR) University of Utah; BioMed Valley Discoveries, Inc All 18 Years and older (Adult, Older Adult) 17 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCI127114 17/03/2020 03/07/2023 30/03/2025 30/10/2019 23/06/2023 https://ClinicalTrials.gov/show/NCT04145297 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Any GI cancer Hydroxychloroquine Safety and/or Dose Phase 1 DB07118 N
NCT00977470 Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations Unknown status Non-small Cell Lung Cancer Drug: Erlotinib; Drug: Hydroxychloroquine Median Progression Free Survival; Nine-month Progression-free Survival Rate; Treatment Related Toxicity, > 10 Frequency, Any Grade; Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.; Overall Survival of Patients Treated With Erlotinib and With Erlotinib/HCQ Massachusetts General Hospital; Stanford University; Yale University; University of Maryland, College Park; Genentech, Inc. All 18 Years and older (Adult, Older Adult) 76 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 09-097; OSI4620s 10/01/2009 05/01/2015 06/01/2021 15/09/2009 06/06/2017 14/07/2020 https://ClinicalTrials.gov/show/NCT00977470 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Lung Non-Small Cell Lung Cancer Hydroxychloroquine PFS Phase 2 DB07118 N
NCT05733000 CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Recruiting Advanced Biliary Tract Carcinoma|Advanced Colorectal Carcinoma|Advanced Gastroesophageal Junction Adenocarcinoma|Advanced Lung Adenocarcinoma|Advanced Malignant Solid Neoplasm|Advanced Ovarian Carcinoma|Advanced Pancreatic Carcinoma|Advanced Urothelial Carcinoma|Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8|Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8|Metastatic Biliary Tract Carcinoma|Metastatic Colorectal Carcinoma|Metastatic Gastroesophageal Junction Adenocarcinoma|Metastatic Lung Adenocarcinoma|Metastatic Ovarian Carcinoma|Metastatic Pancreatic Carcinoma|Metastatic Urothelial Carcinoma|Refractory Biliary Tract Carcinoma|Refractory Colorectal Carcinoma|Refractory Gastroesophageal Junction Adenocarcinoma|Refractory Lung Adenocarcinoma|Refractory Ovarian Carcinoma|Refractory Pancreatic Carcinoma|Refractory Urothelial Carcinoma|Stage II Pancreatic Cancer AJCC v8|Stage III Colorectal Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage III Ovarian Cancer AJCC v8|Stage III Pancreatic Cancer AJCC v8|Stage IV Colorectal Cancer AJCC v8|Stage IV Lung Cancer AJCC v8|Stage IV Ovarian Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8 Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Devimistat; Drug: Fluorouracil; Drug: Gemcitabine Hydrochloride; Drug: Hydroxychloroquine; Procedure: Magnetic Resonance Imaging Overall response rate (ORR); Progression free survival (PFS); Overall survival (OS); Duration of response (DOR); Incidence of adverse events Northwestern University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 94 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NU 22MH03; NCI-2023-00070; STU00218203; P30CA060553 03/08/2023 01/04/2028 03/04/2030 17/02/2023 03/10/2023 https://ClinicalTrials.gov/show/NCT05733000 Recurrent/Refractory Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Hydroxychloroquine Response rate Phase 2 DB07118 N
NCT04527549 Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma Active, not recruiting Clinical Stage IV Cutaneous Melanoma AJCC v8|Locally Advanced Melanoma|Pathologic Stage IIIC Cutaneous Melanoma AJCC v8|Pathologic Stage IV Cutaneous Melanoma AJCC v8|Unresectable Melanoma Drug: Dabrafenib Mesylate; Drug: Hydroxychloroquine Sulfate; Drug: Placebo Administration; Drug: Trametinib Dimethyl Sulfoxide Progression-free survival (PFS) rate; PFS distribution; Overall response rate; Complete response rate; Overall survival; Incidence of adverse events; Treatment duration ECOG-ACRIN Cancer Research Group; National Cancer Institute (NCI); Eastern Cooperative Oncology Group All 18 Years and older (Adult, Older Adult) 84 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment EA6191; NCI-2020-04552; U10CA180820 06/01/2021 30/11/2025 30/11/2025 26/08/2020 22/06/2023 https://ClinicalTrials.gov/show/NCT04527549 Advanced/Metastatic Collaborative Group Y N N United States Skin Melanoma Hydroxychloroquine PFS Phase 2 DB07118 N
NCT04669197 Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer Active, not recruiting Untreated Resectable Pancreatic Adenocarcinoma|Borderline Resectable Pancreatic Adenocarcinoma|Locally Advanced Pancreatic Adenocarcinoma Drug: Paclitaxel protein bound; Drug: Gemcitabine; Drug: Cisplatin; Drug: Hydroxychloroquine Normalization Rate of CA 19-9; Resectability Rate; Survival Rate; Response Rate; Incidence of Treatment-Emergent Adverse Events HonorHealth Research Institute All 18 Years and older (Adult, Older Adult) 19 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCQ NABPLAGEM-NEO 2020 12/01/2020 23/05/2023 30/09/2024 16/12/2020 15/08/2023 https://ClinicalTrials.gov/show/NCT04669197 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; Biomarker; Other (specify) Phase 2 DB07118 N
NCT04911816 Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma Recruiting Adenocarcinoma of the Pancreas Drug: Hydroxychloroquine sulfate Phase I - Establishing Maximum tolerated dose (MTD); Phase II - Rate of grade IIb or better histopathological response; Phase II - To establish the potential biological activity of FHQ by biochemical tumor response, as assessed by Ca 19-9. West Virginia University All 18 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2103260669 16/07/2021 06/01/2025 06/01/2028 06/03/2021 01/12/2024 https://ClinicalTrials.gov/show/NCT04911816 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; Biomarker Phase 1/2 DB07118 N
NCT04464759 A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma LIMIT Recruiting Melanoma Drug: Nivolumab; Drug: Hydroxychloroquine; Drug: Ipilimumab Phase 1: Maximum tolerated dose (MTD) - Number of Subjects with Dose-limiting Toxicities; Phase 2: Objective Response Rate (ORR); Progression-free survival; 1 year survival rate Ravi Amaravadi, MD; Bristol-Myers Squibb; Abramson Cancer Center at Penn Medicine All 18 Years and older (Adult, Older Adult) 94 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UPCC 01620; IRB#835033 21/10/2020 30/10/2025 30/10/2025 07/09/2020 10/10/2023 https://ClinicalTrials.gov/show/NCT04464759 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB07118 N
NCT03754179 Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma COMBI-R2 Unknown status Melanoma Drug: Dabrafenib; Drug: Trametinib; Drug: Hydroxychloroquine Ph. 1: incidence of adverse events of DAB, TRA and HCQ; Ph. 2 Arm A: objective response rate (ORR) of DAB, TRA and HCQ; Ph. 1: objective response rate (ORR) of DAB, TRA and HCQ; Ph. 1: progression-free survival (PFS) on DAB, TRA and HCQ; Ph. 1: overall survival (OS) on DAB, TRA and HCQ; Ph. 1: value of BRAF V600 mutant circulating tumor DNA (ctDNA) as a predictive and/or prognostic marker during treatment DAB, TRA and HCQ; Ph. 2 Arm B: objective response rate 1 (ORR 1) of DAB and TRA prior to the addition of HCQ at progression of disease; Ph. 2 Arm B: objective response rate 2 (ORR 2) of DAB and TRA following the addition of HCQ at progression of disease; Ph. 2 Arm A: progression-free survival (PFS) on DAB, TRA and HCQ; Ph. 2 Arm A: overall survival (OS) on DAB, TRA and HCQ; Ph. 2 Arm B: progression-free survival 1 (PFS 1) on DAB and TRA prior to the addition of HCQ; Ph. 2 Arm B: progression-free survival 2 (PFS 2) on DAB and TRA following the addition of HCQ; Ph. 2 Arm B: overall survival 1 (OS 1) on DAB and TRA prior to the addition of HCQ; Ph. 2 Arm B: overall survival 2 (OS 2) on DAB and TRA following the addition of HCQ; Ph. 2 Arm B: overall survival 3 (OS 3) on DAB and TRA following the addition of HCQ; Ph. 2 Arm A and B: incidence of adverse events of DAB, TRA and HCQ; Ph. 2 Arm A and B: value of BRAF V600 mutant circulating tumor DNA (ctDNA) as a predictive and/or prognostic marker during treatment with DAB, TRA and HCQ Universitair Ziekenhuis Brussel; University Hospital, Ghent All 18 Years and older (Adult, Older Adult) 63 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2017-BN-004 23/01/2018 12/01/2021 07/01/2022 27/11/2018 28/04/2021 https://ClinicalTrials.gov/show/NCT03754179 Advanced/Metastatic Hospital/University/Research Institute N Y N Belgium Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB07118 N
NCT03598595 Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma Active, not recruiting Recurrent Osteosarcoma|Refractory Osteosarcoma Drug: Docetaxel; Drug: Gemcitabine; Drug: Hydroxychloroquine Maximum tolerated dose of hydroxychloroquine (Phase I); Disease control rate (Phase II); Event free survival; Overall response (complete response [CR] or partial response [PR] versus not CR or PR) M.D. Anderson Cancer Center; National Cancer Institute (NCI) All 12 Years and older (Child, Adult, Older Adult) 31 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2018-0224; NCI-2018-01414 28/01/2019 13/09/2024 13/09/2024 26/07/2018 18/11/2023 https://ClinicalTrials.gov/show/NCT03598595 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Bone Sarcoma Osteosarcoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB07118 N
NCT04201457 A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration Recruiting Low Grade Glioma (LGG) of Brain With BRAF Aberration|High Grade Glioma (HGG) of the Brain With BRAF Aberration|Low Grade Glioma of Brain With Neurofibromatosis Type 1 Drug: Dabrafenib; Drug: Trametinib; Drug: Hydroxychloroquine Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D); Maximum Plasma Concentration; Area under the curve (AUC); Phase II: Sustained objective response rate.; Phase I: Dose limiting toxicities of D + T HCQ or T + HCQ; Phase I: Response Rate; Phase II: Progression-free survival; Phase II: Visual outcome based on Teller Grating Acuity at 55 cm in the left eye in children with tumor involving the visual pathway; Phase I and II: Autophagy inhibition as assessed by the accumulation of LC3II in peripheral blood mononuclear cells; Phase I and II: Autophagy inhibition as assessed by the accumulation of p62 in peripheral blood mononuclear cells; Phase I and II: Presence of MAPK pathway aberrations (other than BRAF) as assessed by whole exome sequencing; Phase I and II: biomarker of resistance to RAF or MEK inhibitor therapy by evaluating matched primary and recurrent/progressive in tumor in plasma (and CSF if clinically indicated) Pediatric Brain Tumor Consortium All 1 Year to 30 Years (Child, Adult) 75 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PBTC-055 17/01/2020 30/08/2025 30/06/2027 17/12/2019 01/11/2023 https://ClinicalTrials.gov/show/NCT04201457 Recurrent/Refractory Collaborative Group N N Y United States CNS Glioma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB07118 N
NCT03979651 MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma CHLOROTRAMMEL Unknown status Metastatic NRAS Melanoma Drug: Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 1); Drug: Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 2); Drug: Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 3) Incidence of Dose-Limiting Toxicities (DLTs); Percentage of patients with a partial or complete response to treatment; Change in Median progression Free survival; Change in Overall Survival; Safety of the drug combination Trametinib and Hydroxychloroquine; Quantification of the autophagic substrate p62; Quantification of Microtubule-associated protein Light Chain 3 (LC3); Quantification of p-ERK; Quantification of the autophagic substrate p62 (cutaneous metastasis); Quantification of Microtubule-associated protein Light Chain 3 (LC3) (cutaneous metastasis); Quantification of p-ERK (cutaneous metastasis); Serum trametinib and hydroxychloroquine concentrations (AUC); Changes in treatment induced immune modifications in patient blood serum Hospices Civils de Lyon All 18 Years and older (Adult, Older Adult) 29 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 69HCL19_0115; 2019-001399-13 15/10/2019 31/03/2022 31/03/2022 06/07/2019 05/08/2020 https://ClinicalTrials.gov/show/NCT03979651 Advanced/Metastatic Hospital/University/Research Institute N N N France Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB07118 N
NCT05842174 Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma TAQE Not yet recruiting Hepatocellular Carcinoma Drug: Hydroxychloroquine; Drug: Lipiodol; Drug: Placebo Local Progression Free Survival VA Office of Research and Development All 18 Years and older (Adult, Older Adult) 93 U.S. Fed Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment ONCC-008-22S; IO1CX002542 09/01/2023 31/08/2027 31/08/2028 05/03/2023 05/03/2023 https://ClinicalTrials.gov/show/NCT05842174 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Liver Cancer Hydroxychloroquine PFS Phase 1/2 DB07118 N
NCT03273231 The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection Unknown status Colorectal Cancer Drug: Ketamine; Drug: Saline natural killer cell cytotoxicity; proinflammatory cytokine; recurrence; metastasis Yonsei University All 20 Years to 80 Years (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Other 4-2017-0475 09/01/2017 07/01/2020 07/01/2020 09/06/2017 16/01/2019 https://ClinicalTrials.gov/show/NCT03273231 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Colon Cancer; Rectal Cancer Ketamine Biomarker Other DB01026 N
NCT02470299 Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients Active, not recruiting Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer Drug: Ketorolac; Other: Placebo Ketorolac inhibition of GTPase activity; Intraperitoneal and serum pharmacokinetics of ketorolac; Time to CA-125 normalization; Toxicity assessment New Mexico Cancer Care Alliance Female 18 Years and older (Adult, Older Adult) 21 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Basic Science INST 1420 29/10/2015 10/08/2018 10/08/2025 06/12/2015 01/11/2024 https://ClinicalTrials.gov/show/NCT02470299 Localised/Locoregional Hospital/University/Research Institute Y N N United States Gynaecological Fallopian Tube Cancer; Primary Peritoneal Cancer; Ovarian Epithelial Cancer Ketorolac Safety and/or Dose; Biomarker Other DB00555 N
NCT04549662 The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial PRIMe Recruiting Hepatopancreaticobiliary (HPB) Malignancy|Surgery Dietary Supplement: Active A; Dietary Supplement: Active B; Dietary Supplement: Lipid bolus; Dietary Supplement: Placebo oil Natural killer (NK) cell killing; Secondary immune function outcomes: Immune cell subsets; Secondary immune function outcomes: NK cell activating and inhibitory receptors; Secondary immune function outcomes: amino acid levels; Incidence of pancreatic fistula; Postoperative wound complication and surgical site infection; Length of stay; 90-day postoperative complications (Clavien-Dindo 3-5); 90-day postoperative mortality; Incidence of liver insufficiency Sunnybrook Health Sciences Centre; Enhanced Medical Nutrition; Sunnybrook Health Sciences Centre Clinical Research Grant Competition; Sunnybrook Health Sciences Centre AFP Innovation Fund All 18 Years and older (Adult, Older Adult) 45 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 076-2017 16/06/2021 30/12/2023 30/12/2025 16/09/2020 13/10/2023 https://ClinicalTrials.gov/show/NCT04549662 Localised/Locoregional Hospital/University/Research Institute Y Y N United States GI Pancreatic Cancer L-Arginine; Omega 3 Biomarker Other DB01097; DB00338 N
NCT04997993 Leflunomide in Patients With PTEN-null Advanced Solid Malignancies Recruiting PTEN-null Advanced Solid Tumors Drug: Leflunomide Number of participants with Dose-limiting toxicities; Number of Dose-limiting toxicities; Maximum tolerated dose; Overall Response Rate Deborah Doroshow; Icahn School of Medicine at Mount Sinai All 18 Years and older (Adult, Older Adult) 24 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GCO 20-2528 13/12/2023 09/01/2026 09/01/2026 08/10/2021 29/12/2023 https://ClinicalTrials.gov/show/NCT04997993 Advanced/Metastatic Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Leflunomide Safety and/or Dose; Response rate Phase 1 DB00848 N
NCT04508790 Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma Recruiting Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma Drug: Dexamethasone; Drug: Leflunomide; Drug: Pomalidomide Overall response; Incidence of adverse events; Response duration; Depth of response; Clinical benefit response; Overall survival; Minimal residual disease (MRD) status City of Hope Medical Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 29 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 19418; NCI-2020-01962 27/11/2020 30/06/2024 30/06/2024 08/11/2020 08/04/2023 https://ClinicalTrials.gov/show/NCT04508790 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Leflunomide Safety and/or Dose; Response rate; OS Phase 2 DB00848 N
NCT02815410 Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients Unknown status Glioblastoma Multiforme Drug: levetiracetam 6 months Progression free survival; Overall survival Seoul National University Hospital All 20 Years to 76 Years (Adult, Older Adult) 73 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment cykim 07/01/2016 06/01/2019 06/01/2022 28/06/2016 28/06/2016 https://ClinicalTrials.gov/show/NCT02815410 Localised/Locoregional Hospital/University/Research Institute N N N Korea, Republic of CNS Glioblastoma Levetiracetam PFS; OS Phase 2 DB01137 N
NCT02035787 Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients Active, not recruiting Complex Atypical Hyperplasia|Endometrial Cancer Drug: Metformin Response rate; adverse event measurement UNC Lineberger Comprehensive Cancer Center; Golfers Against Cancer Grant Female 18 Years and older (Adult, Older Adult) 21 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LCCC1326; 12-0886 27/02/2014 04/12/2024 10/01/2024 14/01/2014 30/11/2023 https://ClinicalTrials.gov/show/NCT02035787 Localised/Locoregional Hospital/University/Research Institute N N N United States Gynaecological Endometrial Cancer Metformin Safety and/or Dose; Response rate Other DB00703 N
NCT04710290 A Cohort Study of Beta-Glucan or Beta-Glucan Compound in Metastatic Cancers Unknown status Metastatic Cancer|Chemotherapy Dietary Supplement: Beta-Glucan; Dietary Supplement: Glutamine; Dietary Supplement: Immunoglobuin; Dietary Supplement: Corn starch the change of total white blood cells, neutrophils, and lymphocytes at day 14 of 2nd cycle, from day 7 of 2nd cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 3rd cycle, from day 14 of 2nd cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 3rd cycle, from day 1 of 3rd cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 4th cycle, from day 7 of 3rd cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 5th cycle, from day 7 of 4th cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 5th cycle, from day 1 of 5th cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 6th cycle, from day 7 of 5th cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 6th cycle, from day 1 of 6th cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at day 22 of 6th cycle, from day 7 of 6th cycle of chemotherapy; the change of total white blood cells, neutrophils, and lymphocytes at 2nd month after chemotherapy, from day 22 of 6th cycle of chemotherapy; change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C4D7 from C2D7; change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C6D22 from C4D7; change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at 2 month from C6D22; the change of lymphocyte surface markers percentage at day 7 of 2nd chemotherapy, from baseline.; the change of lymphocyte surface markers percentage at day 14 of 2nd chemotherapy, from day 7 of 2nd chemotherapy; the change of lymphocyte surface markers percentage at day 7 of 4th cycle of chemotherapy, from day 14 of 2nd chemotherapy; the change of lymphocyte surface markers percentage at day 22 of 6th cycle of chemotherapy, from day 7 of 4th cycle of chemotherapy; the change of lymphocyte surface markers percentage at 2 month after 6th cycle of chemotherapy, from day 22 of 6th cycle of chemotherapy; analysis overall survival E-DA Hospital All 20 Years and older (Adult, Older Adult) 90 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care EMRP50106N 01/04/2018 31/12/2021 31/12/2021 14/01/2021 25/01/2021 https://ClinicalTrials.gov/show/NCT04710290 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N Taiwan Multiple cancer types Any solid tumours L-Glutamine QoL; Biomarker Phase 2/3 DB00281 N
NCT05250791 Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome FLICOR Recruiting Colorectal Cancer|Quality of Life|Recurrent Cancer Drug: Lidocaine hydrochloride 2 for injection; Drug: 0.9 sterile Sodium Chloride solution for injection Feasibility of recruitment; Trial retention; The completion of data collection instruments; Participant's feedback of study experiences; Clinical staff feedback of study experiences; Patients' reasons to refuse consent.; Clinicians' reasons for not recruiting patients.; Disease-free survival; Completion of EQ-5D-5L; Completion of the cancer-specific quality of life questionnaires; Completion of healthcare and social care resource use questionnaires; Total hospital stays including readmission Imperial College London All 18 Years and older (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 21CX7298; 2021-006185-20; NIHR301741; 1004491 02/02/2023 15/09/2024 15/09/2024 22/02/2022 06/09/2023 https://ClinicalTrials.gov/show/NCT05250791 Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom GI Colon Cancer; Rectal Cancer Lidocaine DFS/RFS/EFS; QoL; Other (specify) Other DB08882 N
NCT05560035 The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery Not yet recruiting Cervical Cancer|Metastatic Cancer Drug: Lidocaine; Other: Normal saline (NS) Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery; Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery; Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery; Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery; Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively; Resumption of bowel function General Hospital of Ningxia Medical University Female 18 Years to 65 Years (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Prevention maling20220922 12/01/2022 07/01/2024 12/01/2024 29/09/2022 29/09/2022 https://ClinicalTrials.gov/show/NCT05560035 Any/All Stages Hospital/University/Research Institute Y N N China Gynaecological Cervical Cancer Lidocaine Biomarker Other DB08882 N
NCT04449289 Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery Not yet recruiting Pancreatic Cancer Drug: Intravenous lidocaine; Drug: Epidural ropivacaine 1- and 3-years recurrence rate after surgery; 1- and 3-years survival after surgery; Lidocaine and ropivacaine concentration; Complication rate after surgery Institutul Regional de Gastroenterologie Hepatologie Prof. dr. Octavian Fodor All 18 Years to 80 Years (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 43/3.02.2020 07/01/2020 31/12/2021 31/12/2024 26/06/2020 26/06/2020 https://ClinicalTrials.gov/show/NCT04449289 Localised/Locoregional Hospital/University/Research Institute Y N N Romania GI Pancreatic Cancer Lidocaine Recurrence rate Phase 2 DB08882 N
NCT04316013 Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial Recruiting Colonic Cancer|Rectal Cancer|Non Small Cell Lung Cancer Drug: Sevoflurane; Drug: Propofol; Drug: Lidocaine IV Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane; Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine; Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane; Days alive and at home with propofol-TIVA versus sevoflurane; Overall survival with intravenous lidocaine versus no lidocaine; Days alive and at home with intravenous lidocaine versus no lidocaine; Comparison of post-operative complications with propofol-TIVA versus sevoflurane; Comparison of post-operative complications with intravenous lidocaine versus no lidocaine; Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane; Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine; Safety profile of propofol-TIVA versus sevoflurane; Safety Profile intravenous lidocaine versus no lidocaine; Concomitant medication use with propofol-TIVA versus sevoflurane; Concomitant medications use with intravenous lidocaine versus no lidocaine; Health utility with propofol-TIVA versus sevoflurane; Health utility with intravenous lidocaine versus no lidocaine Peter MacCallum Cancer Centre, Australia; National Health and Medical Research Council, Australia; Australian and New Zealand College of Anaesthetists; Victorian Comprehensive Cancer Centre All 18 Years and older (Adult, Older Adult) 3500 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Other 18/044 31/07/2020 12/01/2027 06/01/2028 20/03/2020 23/03/2023 https://ClinicalTrials.gov/show/NCT04316013 Perioperative Localised/Locoregional Hospital/University/Research Institute Y Y N Australia GI; Lung Colon Cancer; Rectal Cancer; Non-Small Cell Lung Cancer Lidocaine DFS/RFS/EFS Phase 3 DB08882 N
NCT04162535 Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery Unknown status Colorectal Cancer Drug: Lidocaine 1 Injectable Solution; Biological: Blood extraction; Drug: Sevoflurane; Drug: Propofol Evaluation of the antiproliferative and apoptotic effects of anesthetic agents; Evaluation of patients serum on cell culture; Lidocaine concentration; Survival Comparison Iuliu Hatieganu University of Medicine and Pharmacy; Institutul Regional de Gastroenterologie Hepatologie Prof. dr. Octavian Fodor; Prof. Dr. I. Chiricuta Institute of Oncology All 18 Years to 80 Years (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Basic Science 418/14.11.2018 26/11/2018 31/12/2023 31/12/2023 14/11/2019 02/10/2021 https://ClinicalTrials.gov/show/NCT04162535 Localised/Locoregional Hospital/University/Research Institute Y Y N Romania GI Colon Cancer; Rectal Cancer Lidocaine Biomarker Phase 1 DB08882 N
NCT01042379 I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer I-SPY Recruiting Breast Neoplasms|Breast Cancer|Breast Tumors|Angiosarcoma|TNBC - Triple-Negative Breast Cancer|HER2-positive Breast Cancer|HER2-negative Breast Cancer|Hormone Receptor Positive Tumor|Hormone Receptor Negative Tumor|Early-stage Breast Cancer|Locally Advanced Breast Cancer Drug: Standard Therapy; Drug: AMG 386 with or without Trastuzumab; Drug: AMG 479 (Ganitumab) plus Metformin; Drug: MK-2206 with or without Trastuzumab; Drug: AMG 386 and Trastuzumab; Drug: T-DM1 and Pertuzumab; Drug: Pertuzumab and Trastuzumab; Drug: Ganetespib; Drug: ABT-888; Drug: Neratinib; Drug: PLX3397; Drug: Pembrolizumab - 4 cycle; Drug: Talazoparib plus Irinotecan; Drug: Patritumab and Trastuzumab; Drug: Pembrolizumab - 8 cycle; Drug: SGN-LIV1A; Drug: Durvalumab plus Olaparib; Drug: SD-101 + Pembrolizumab; Drug: Tucatinib plus trastuzumab and pertuzumab; Drug: Cemiplimab; Drug: Cemiplimab plus REGN3767; Drug: Trilaciclib with or without trastuzumab + pertuzumab; Drug: SYD985 ([vic-]trastuzumab duocarmazine); Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab; Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab; Drug: Amcenestrant; Drug: Amcenestrant + Abemaciclib; Drug: Amcenestrant + Letrozole; Drug: ARX788; Drug: ARX788 + Cemiplimab; Drug: VV1 + Cemiplimab; Drug: Datopotamab deruxtecan; Drug: Datopotamab deruxtecan + Durvalumab; Drug: Zanidatamab; Drug: Lasofoxifene; Drug: Z-endoxifen; Drug: ARV-471; Drug: ARV-471 + Letrozole Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.; Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).; To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.; To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.; MRI Volume QuantumLeap Healthcare Collaborative All 18 Years and older (Adult, Older Adult) 5000 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 97517 03/01/2010 12/01/2030 12/01/2031 01/05/2010 27/07/2023 https://ClinicalTrials.gov/show/NCT01042379 Localised/Locoregional Other N Y N United States Breast Any Breast Cancer Metformin Response rate Phase 1 DB00703 N
NCT05861336 GEM+Nab-Paclitaxel Plus Losartan Followed by Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer OVERPASS Recruiting Pancreatic Cancer Drug: Losartan; Drug: Gemcitabine; Drug: Nab paclitaxel; Radiation: Stereotactic Body Radiation Therapy Number of participants discontinuing study treatment due to treatment related grade 3 non-hematological adverse event [Toxicity]; Number of participants discontinuing study treatment due to treatment related grade 3 adverse event [Toxicity]; Resectability rate; margin-negative resection rate (R0); progression-free survival (PFS); overall survival (OS); biomarker blood response; Incidence of Treatment-Emergent Adverse Events [Toxicity]; Quality of life questionnaire (QLQ) Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori All 18 Years to 75 Years (Adult, Older Adult) 34 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRST157.04 14/06/2023 08/01/2026 08/01/2029 16/05/2023 01/05/2024 https://ClinicalTrials.gov/show/NCT05861336 Localised/Locoregional Hospital/University/Research Institute N N N Italy GI Pancreatic Cancer Losartan Safety and/or Dose; Other (specify) Phase 2 DB00227 N
NCT04106856 Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER) SHAPER Recruiting Borderline Resectable Pancreatic Adenocarcinoma|Locally Advanced Pancreatic Ductal Adenocarcinoma|Locally Advanced Unresectable Pancreatic Adenocarcinoma|Stage II Pancreatic Cancer AJCC v8|Stage IIA Pancreatic Cancer AJCC v8|Stage IIB Pancreatic Cancer AJCC v8|Stage III Pancreatic Cancer AJCC v8 Radiation: Hypofractionated Radiation Therapy; Drug: Losartan; Drug: Losartan Potassium; Other: Quality-of-Life Assessment; Other: Questionnaire Administration Grade 3 or higher gastrointestinal toxicity rate; Frequency of adverse events; Response rate (clinical and/or pathologic partial response [PR] and complete response [CR]); Progressive free survival (PFS); Overall survival (OS); Number patients that require a medical intervention or hospitalization due to hypotension University of Utah; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 20 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCI121104; NCI-2019-05882; P30CA042014 08/08/2019 08/08/2025 08/08/2026 27/09/2019 07/03/2023 https://ClinicalTrials.gov/show/NCT04106856 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Losartan Safety and/or Dose Phase 1 DB00227 N
NCT05077800 FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer Recruiting Pancreatic Adenocarcinoma|Pancreatic Adenocarcinoma Metastatic Drug: FOLFIRNINOX; Drug: Losartan; Drug: 9-ING-41 Progression-free survival (PFS); Overall survival (OS); Median time of maintenance therapy (mMT):; Objective Response Rate Colin D. Weekes, M.D.; Actuate Therapeutics Inc.; Lustgarten Foundation; Massachusetts General Hospital All 18 Years and older (Adult, Older Adult) 70 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 21-350 21/03/2022 31/12/2023 31/07/2024 14/10/2021 06/09/2022 https://ClinicalTrials.gov/show/NCT05077800 Advanced/Metastatic Hospital/University/Research Institute Y Y N United States GI Pancreatic Cancer Losartan PFS Phase 2 DB00227 N
NCT03900793 Losartan + Sunitinib in Treatment of Osteosarcoma Recruiting Osteosarcoma Drug: Losartan; Drug: Sunitinib Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination; Maximally Tolerated Dose of Losartan and Sunitinib; Recommended Phase 2 Dose of Losartan and Sunitinib; Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Maximum Peak Concentration; Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Time to Peak Concentration; Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCL2-Mediated Chemotactic Index; Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: Plasma CCL2 Levels; Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCR2+ Monocyte Population; Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR); Preliminary: Progression Free Survival (PFS) University of Colorado, Denver All 10 Years to 40 Years (Child, Adult) 41 Other Interventional Study Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 18-2740.cc; NCI-2019-06119 26/08/2019 02/01/2024 02/01/2025 04/03/2019 30/11/2023 https://ClinicalTrials.gov/show/NCT03900793 Recurrent/Refractory Hospital/University/Research Institute N N N United States Bone Sarcoma Osteosarcoma Losartan Safety and/or Dose Phase 1 DB00227 N
NCT03306472 A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer PIONEER Unknown status Breast Cancer Drug: Megestrol Acetate 40 MG; Drug: Megestrol Acetate 160 MG; Drug: Letrozole Determination of change in tumour proliferation measured by Ki67 immunohistochemical (IHC) assessment ( ) at baseline compared to Day 15 (+ 4 days).; Change in tumour apoptosis, measured by Caspase 3 (IHC); Change in expression of Androgen receptor and Progesterone receptor by IHC; Change in expression of Epithelial-Mesenchymal Transition (EMT) markers by IHC; Change in proliferation by Aurora Kinase A labeling by IHC; Absolute value of Ki67 at day 15 (+ 4 Days); Incidence and Severity of Adverse Events Cambridge University Hospitals NHS Foundation Trust; Anticancer Fund, Belgium Female 18 Years and older (Adult, Older Adult) 189 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PIONEER; 2016-003752-79 20/07/2017 31/10/2021 30/11/2022 10/11/2017 13/01/2021 https://ClinicalTrials.gov/show/NCT03306472 Localised/Locoregional Hospital/University/Research Institute Y Y N United Kingdom Breast Breast Cancer - ER/HR+ Megestrol Acetate Biomarker Phase 2 DB01065 N
NCT03024580 A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer MEGA Unknown status Breast Neoplasm Drug: Megestrol Acetate 160Mg Tablet; Drug: Anastrozole 1Mg Tablet; Drug: Letrozole 2.5Mg Tablet; Drug: Exemestane 25 MG; Drug: Tamoxifen 20Mg Tablet; Drug: Fulvestrant 50Mg Solution for Injection Progression free survival; Overall survival; Clinical benefit Instituto Nacional de Cancer, Brazil; Cancer Research UK Cambridge Institute Female Child, Adult, Older Adult 20 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 64/16 03/06/2017 03/01/2020 09/01/2020 19/01/2017 15/08/2019 https://ClinicalTrials.gov/show/NCT03024580 Advanced/Metastatic Hospital/University/Research Institute Y Y N Brazil Breast Breast Cancer - ER/HR+ Megestrol Acetate PFS Phase 2 DB01065 N
NCT05247268 Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer Recruiting Endometrial Neoplasm Malignant Stage I Drug: Megestrol Acetate 160 MG Oral Tablet; Drug: Medroxyprogesterone Acetate 500 MG; Drug: Triprorelin Acetate; Drug: Letrozole 2.5mg Complete response rates within 16 weeks of treatment; Complete response rates within 28 weeks of treatment; Time to achieve complete response; Adverse events; Quality of life during the treatment accessed by WHOQOL-BREF; Relapse rates; Change of AMH (anti-mullerian hormone ) serum level; The rates of fertility outcomes Fudan University; Peking Union Medical College Hospital Female 18 Years to 45 Years (Adult) 104 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 53211032 03/11/2022 03/10/2024 03/10/2025 18/02/2022 28/03/2023 https://ClinicalTrials.gov/show/NCT05247268 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate Phase 2 DB01065 N
NCT05538897 Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers Suspended FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma|FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma|Metastatic Endometrial Endometrioid Adenocarcinoma|Recurrent Endometrial Endometrioid Adenocarcinoma|Stage IV Uterine Corpus Cancer AJCC v8 Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Ipatasertib; Procedure: Magnetic Resonance Imaging; Drug: Megestrol Acetate Incidence of adverse events (AEs) (Phase Ib); Maximum tolerated dose for phase II (Phase Ib); Progression free survival (PFS) (Phase II); Incidence of AEs (Phase II); Pharmacokinetics of ipatasertib + megestrol acetate (Phase Ib); Objective response rate (ORR) (Phase II); Biomarkers (Phase II) National Cancer Institute (NCI); NRG Oncology Female 18 Years and older (Adult, Older Adult) 96 NIH; Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2022-07505; NRG-GY028; U10CA180868 31/03/2023 31/01/2027 31/01/2027 14/09/2022 12/06/2023 https://ClinicalTrials.gov/show/NCT05538897 Advanced/Metastatic; Recurrent/Refractory Local/National government N Y N United States Gynaecological Endometrial Cancer Megestrol Acetate Safety and/or Dose; Response rate; PFS Phase 1/2 DB01065 N
NCT03671811 Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy Active, not recruiting Atypical Endometrial Hyperplasia|Endometrial Carcinoma Drug: Megestrol Acetate; Biological: Pterostilbene Tumor Ki-67 proliferation index; Histologic response of gland cellularity; Histologic response of mitotic index; Histologic response of metaplasia; Histologic response of eosinophilic cytoplasm; Immunohistochemical expression of Bcl-2 to assess tumor growth and apoptosis; Immunohistochemical expression of Casp3 to assess tumor growth and apoptosis City of Hope Medical Center; National Cancer Institute (NCI) Female 18 Years and older (Adult, Older Adult) 44 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 17327; NCI-2018-01555; P30CA033572 21/01/2019 11/07/2024 11/07/2024 14/09/2018 01/05/2024 https://ClinicalTrials.gov/show/NCT03671811 Localised/Locoregional Hospital/University/Research Institute Y N N United States Gynaecological Endometrial Cancer Megestrol Acetate Biomarker Phase 2 DB01065 N
NCT05255653 Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features RAINBO Recruiting Endometrial Cancer Drug: Olaparib; Radiation: Pelvic external beam radiotherapy; Drug: Chemotherapy; Drug: Durvalumab; Drug: Medroxyprogesterone Acetate; Drug: Megestrol Acetate; Radiation: Vaginal brachytherapy; Other: Observation p53abn-RED trial; MMRd-GREEN trial; NSMP-ORANGE trial; POLEmut-BLUE trial; Recurrence-free survival; Pelvic recurrence-free survival; Vaginal recurrence-free survival; Endometrial cancer-specific survival; Overall survival; Treatment-related toxicity - according to CTCAE v5.0; Health-related quality of life - Assessed using the EORTC QLQ-C30 questionnaire; Health-related quality of life - Assessed using the EORTC QLQ-EN24 questionnaire Leiden University Medical Center; Institute Gustave Roussy (sponsor p53abn-RED trial); Leiden University Medical center (sponsor MMRd-GREEN trial); University College London (sponsor NSMP-ORANGE trial); Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial); Dutch Gynaecological Oncology Group; Comprehensive Cancer Centre The Netherlands; Cancer Research UK UCL Cancer Trials Centre; Dutch Cancer Society; AstraZeneca; National Cancer Institute, France; Canadian Institutes of Health Research (CIHR) Female 18 Years and older (Adult, Older Adult) 1615 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment RAINBO; ENGOT-en14-1,2,3,4; CCTG EN.10 TAPER arm A POLE 11/11/2021 01/01/2030 01/01/2031 24/02/2022 13/07/2023 https://ClinicalTrials.gov/show/NCT05255653 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands Gynaecological Endometrial Cancer Megestrol Acetate DFS/RFS/EFS Phase 2/3 DB01065 N
NCT04046185 Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer ECCT Unknown status Endometrial Cancer Stage I Drug: PD-1 inhibitor combined progesterone; Drug: progesterone Pathologic complete remission rate of endometrial curettage tissues; Pathologic partial remission rate of endometrial curettage tissues; adverse effects; pregnancy rate Shanghai First Maternity and Infant Hospital Female 18 Years to 45 Years (Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment ECCT001 10/01/2019 10/01/2021 10/01/2022 08/06/2019 08/06/2019 https://ClinicalTrials.gov/show/NCT04046185 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate Phase 1 DB01065 N
NCT04491643 Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma Recruiting Endometrial Carcinoma Stage I Drug: Megestrol Acetate; Drug: Rosuvastatin Pathological response rate; Pathological response duration; Pathological response rate classified by different blood lipid level; Toxicity evaluation; Relapse rate; Pregnancy rate Fudan University Female 18 Years to 45 Years (Adult) 48 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 53211029-02 09/01/2020 31/08/2023 31/08/2023 29/07/2020 17/02/2023 https://ClinicalTrials.gov/show/NCT04491643 Localised/Locoregional Hospital/University/Research Institute N N N China Gynaecological Endometrial Cancer Megestrol Acetate; Rosuvastatin Response rate Phase 2 DB01065; DB10276 N
NCT05316467 Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma Recruiting Endometrial Carcinoma|Obese|Overweight|Fertility Issues Behavioral: Intensive Lifestyle Intervention (ILI); Drug: Megestrol Acetate 160 MG Oral Tablet Pathological complete response (CR) rates; Pregnancy outcomes; Weight change; Change of body composition; Change of heart rates; Change of blood pressures; Blood glucose change; Blood lipids change; Insulin resistance change; Ovarian reserve function change; Quality of life change; Physical activities change; Chronic inflammatory indexes change; Time of pathological complete response (CR); Incidence of adverse events; Relapse rates Xiaojun Chen; Fudan University Female 18 Years to 45 Years (Adult) 89 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 53211036-01 05/01/2022 28/02/2024 28/02/2026 04/07/2022 31/05/2023 https://ClinicalTrials.gov/show/NCT05316467 Localised/Locoregional Hospital/University/Research Institute N N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate; QoL; Biomarker; Other (specify) Phase 2/3 DB01065 N
NCT02506777 Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. MBC1 Unknown status Breast Cancer Drug: metformin; Drug: Fluoruracil; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: melatonin Response rate; Pathomorphological response; Adverse events incidence N.N. Petrov National Medical Research Center of Oncology Female 18 Years and older (Adult, Older Adult) 96 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MBC1 07/01/2015 08/01/2020 08/01/2020 23/07/2015 09/04/2019 https://ClinicalTrials.gov/show/NCT02506777 Localised/Locoregional Hospital/University/Research Institute Y Y N Russian Federation Breast Any Breast Cancer Melatonin; Metformin Response rate Phase 2 DB00814; DB00703 N
NCT02506790 Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer Unknown status Breast Cancer Drug: metformin; Drug: Melatonin; Drug: Toremifene Response rate; Pathomorphological response; Adverse events incidence N.N. Petrov National Medical Research Center of Oncology Female 18 Years and older (Adult, Older Adult) 96 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MBC 2 07/01/2015 08/01/2020 08/01/2022 23/07/2015 09/04/2019 https://ClinicalTrials.gov/show/NCT02506790 Localised/Locoregional Hospital/University/Research Institute N N N Russian Federation Breast Any Breast Cancer Melatonin; Metformin Response rate Phase 2 DB00814; DB00703 N
NCT05502900 Adjuvant Melatonin for Uveal Melanoma AMUM Recruiting Uveal Melanoma|Uveal Melanoma, Posterior, Medium/Large Size|Eye Cancer, Intraocular Melanoma Drug: Melatonin Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as relative risk (RR).; Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as Cox regression hazard ratio (HR).; Overall survival (OS) time from randomization in Melatonin vs. Control arm, evaluated with the Log-rank test.; Overall survival (OS) time from the detection of metastasis in Melatonin vs. Control arm, evaluated with the Log-rank test.; Number of patients that develop other cancers (i.e., cancer diagnoses other than uveal melanoma) in Melatonin vs. Control arm, evaluated as relative risk (RR).; Number of patients that develop other cancers (i.e., cancer diagnoses other than uveal melanoma) in Melatonin vs. Control arm, evaluated as Cox regression hazard ratio (HR).; Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) in Melatonin vs. Control arm, as assessed by CTCAE v5.0. Gustav Stalhammar; Karolinska Trial Alliance; Swedish Cancer Society; The Swedish Eye Foundation ( gonfonden); The Swedish Society of Medicine; St. Erik Eye Hospital All 18 Years and older (Adult, Older Adult) 100 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention AMUM v 2.0; 2022-500307-49 10/02/2022 01/01/2031 01/01/2031 16/08/2022 22/11/2023 https://ClinicalTrials.gov/show/NCT05502900 Adjuvant/Maintenance Localised/Locoregional Collaborative Group N N N Sweden Ocular Melanoma - Intraocular Melatonin OS; Recurrence rate Phase 3 DB00814 N
NCT04530097 Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC Unknown status NSCLC and Theropy Procedure: RFA overall survival rate OS; DFS Shanghai 10th People's Hospital All 18 Years to 85 Years (Adult, Older Adult) 260 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2020KT128 01/01/2021 30/09/2022 30/09/2022 28/08/2020 28/08/2020 https://ClinicalTrials.gov/show/NCT04530097 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Melatonin OS Other DB00814 N
NCT04559308 The Effect of Metformin on Breast Cancer Patients Unknown status Breast Cancer Drug: Metformin; Drug: Chemotherapy Clinical benefit rate (Tumor size); Pathological complete response; Number of participants with metformin-related adverse events; The effect of metformin on the quality of life of breast cancer patients Beni-Suef University; Ahram Canadian University Female 18 Years to 65 Years (Adult, Older Adult) 80 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BSU 06/01/2019 15/09/2020 10/01/2020 22/09/2020 22/09/2020 https://ClinicalTrials.gov/show/NCT04559308 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Metformin Response rate Phase 2 DB00703 N
NCT04926155 The Effect of Metformin in Patients With Metastatic Castration-resistant Prostate Cancer Not yet recruiting Metastatic Prostate Cancer Drug: Metformin Progression-free survival defined from randomization to time till biochemical progression or radiographic progression; Overall survival defined from randomization until death due to any reason; Radiographic progression-free survival defined from randomization until radiographic progression; Adverse events which will be assessed according to NCI-CTC AE 5.0 Sun Yat-sen University Male 18 Years and older (Adult, Older Adult) 234 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-FXY-072 23/06/2021 30/04/2024 31/08/2024 14/06/2021 14/06/2021 https://ClinicalTrials.gov/show/NCT04926155 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Urological Prostate Cancer Metformin PFS; OS Phase 2 DB00703 N
NCT05921942 The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer Recruiting Colorectal Cancer Drug: Metformin Disease Control Rate according to Response evaluation criteria in solid tumors ( RECIST) 1.1; Progression free survival; IL-6 Levels; Overall Survival; Common terminology criteria adverse events (CTCAE 4.0) Ain Shams University All 18 Years to 65 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention 262 15/04/2020 21/07/2023 09/06/2023 27/06/2023 27/06/2023 https://ClinicalTrials.gov/show/NCT05921942 Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer Metformin PFS; OS; Other (specify) Phase 3 DB00703 N
NCT03379909 Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer TROJAN Recruiting Superficial Bladder Cancer|Bladder Cancer Drug: Metformin Overall response; Time to recurrence; Toxicity of metformin treatment; Partial response Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Radboud University Medical Center All 18 Years and older (Adult, Older Adult) 49 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Medonc-17-11 09/01/2019 31/07/2024 10/01/2029 20/12/2017 21/09/2023 https://ClinicalTrials.gov/show/NCT03379909 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands Urological Bladder Cancer Metformin Response rate Phase 2 DB00703 N
NCT02339168 Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer Active, not recruiting Prostate Cancer Drug: Enzalutamide; Drug: Metformin Hydrochloride DLT graded accorded to the National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Incidence of adverse events graded according to NCI CTCAE version 4.0; PSA response rate as determined by percent of patients achieving >= 50 PSA decline following initiation of treatment; PSA progression by Prostate Cancer Working Group (PCWG) 2, defined as the date that a 25 or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later; Radiographic disease progression, determined by Response Evaluation Criteria in Solid Tumors version 1.1; Progression-free survival; Time to treatment failure which includes discontinuing therapy because of disease progression, toxicity, or patient withdrawal University of California, Davis; National Cancer Institute (NCI); Medivation, Inc.; Astellas Pharma Inc Male 18 Years and older (Adult, Older Adult) 24 Other; NIH; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 680462; UCDCC#243; P30CA093373; NCI-2014-02668 22/06/2016 04/01/2024 12/01/2024 15/01/2015 31/08/2023 https://ClinicalTrials.gov/show/NCT02339168 Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Prostate Cancer Metformin Safety and/or Dose Phase 1 DB00703 N
NCT03238495 Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer HERMET Unknown status HER2-positive Breast Cancer Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab; Drug: Metformin Pathologic complete response (pCR) Qamar Khan; University of Kansas Medical Center Female 18 Years and older (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00140673 15/08/2017 06/01/2022 06/01/2023 08/03/2017 12/07/2021 https://ClinicalTrials.gov/show/NCT03238495 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Breast Cancer - HER2+ Metformin Response rate Phase 2 DB00703 N
NCT04925063 The Effect of Metformin in Patients With Newly Diagnosed mHSPC Not yet recruiting Metastatic Prostate Cancer Drug: Metformin Castration-resistant prostate cancer free survival; Overall Survival; Radiographic progression-free survival; Safety Sun Yat-sen University Male 18 Years and older (Adult, Older Adult) 266 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021-FXY-078 16/06/2021 30/04/2027 31/08/2027 14/06/2021 14/06/2021 https://ClinicalTrials.gov/show/NCT04925063 Advanced/Metastatic Hospital/University/Research Institute Y N N China Urological Prostate Cancer Metformin PFS; OS Phase 2 DB00703 N
NCT05680662 The Study of Quadruple Therapy Quercetin, Zinc, Metformin, and EGCG as Adjuvant Therapy for Early, Metastatic Breast Cancer and Triple-negative Breast Cancer, a Novel Mechanism Not yet recruiting Breast Cancer Female|Triple Negative Breast Cancer Combination Product: quercetin, EGCG, metformin , zinc invasive Disease Free Survival at 3 Years from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause; Invasive Disease Free Survival at 10 Years; Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 [; Total patient chair time of drug administration; Breast cancer-specific survival (BCSS) at 10 Years Ministry of Health, Saudi Arabia Female 18 Years to 70 Years (Adult, Older Adult) 200 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment Amr Ahmed 01/01/2023 31/12/2023 31/01/2024 01/11/2023 01/11/2023 https://ClinicalTrials.gov/show/NCT05680662 Localised/Locoregional; Advanced/Metastatic Local/National government Y N N Saudi Arabia Breast Any Breast Cancer Metformin DFS/RFS/EFS Phase 1 DB00703 N
NCT04248998 Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer BREAKFAST Active, not recruiting Triple-negative Breast Cancer Dietary Supplement: Fasting-mimicking diet; Drug: Metformin; Drug: Preoperative chemotherapy pCR rate; Severe adverse events; Safety of the experimental treatments; Compliance with the experimental treatment; RFS; DMFS; OS; Short-term modifications of plasma glycemia (mg/dl); Long-term modifications of plasma glycemia (mg/dl); Short-term modifications of serum insulin concentration ( U/ml); Long-term modifications of serum insulin concentration ( U/ml); Short-term modifications of serum IGF-1 concentration (ng/ml); Long-term modifications ofserum IGF-1 concentration (ng/ml); Short-term modifications of blood lipid profile by UPLC-MS and HPLC-ELDS; Long-term modifications of blood lipid profile by UPLC-MS and HPLC-ELDS; Clinical tumor response; Gene expression profiles; Mutational analyses; Short-term modifications of plasma amino acid profile by UPLC-QDa Mass detector system (Waters); Long-term modifications of plasma amino acid profile by UPLC-QDa Mass detector system (Waters) Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; IFOM ETS - The AIRC Institute of Molecular Oncology; European Institute of Oncology; University of Milan Female 18 Years to 75 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment INT 192/19; 2019-003093-13 05/05/2020 05/01/2024 05/01/2024 30/01/2020 18/01/2023 https://ClinicalTrials.gov/show/NCT04248998 Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Breast Cancer - TNBC Metformin Safety and/or Dose; Response rate; OS; DFS/RFS/EFS; Biomarker Phase 2 DB00703 N
NCT04275713 Altered Tumor Oxygenation by Metformin, a Potential Step in Overcoming Radiotherapy Resistance in LACC METOXY-LACC Recruiting Cervical Cancer Drug: Metformin; Drug: Cisplatin Metformin dependent changes in hypoxia-related gene expression.; Metformin dependent changes in MRI-parameters.; Metformin dependent change in acute toxicity; Metformin dependent change in tumor volume during treatment Oslo University Hospital Female 18 Years and older (Adult, Older Adult) 90 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment METOXY-LACC 22/05/2020 05/01/2025 09/01/2025 19/02/2020 05/03/2022 https://ClinicalTrials.gov/show/NCT04275713 Localised/Locoregional Hospital/University/Research Institute Y N N Norway Gynaecological Cervical Cancer Metformin Biomarker Phase 2 DB00703 N
NCT05445791 Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations METLUNG Recruiting Non Small Cell Lung Cancer Drug: Metformin Hydrochloride; Other: Placebo Progression-free survival; Overall survival; Overall Response Rate Instituto Nacional de Cancerologia de Mexico All 18 Years and older (Adult, Older Adult) 312 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment (020/023/ICI) (CEI/1421/19) 15/07/2021 14/07/2024 14/07/2025 07/06/2022 27/06/2023 https://ClinicalTrials.gov/show/NCT05445791 Advanced/Metastatic Hospital/University/Research Institute Y N N Mexico Lung Non-Small Cell Lung Cancer Metformin PFS Phase 3 DB00703 N
NCT03047837 A Randomized, 2x2 Factorial Design Biomarker Prevention Trial of Low-dose Aspirin and Metformin in Stage I-III Colorectal Cancer Patients. ASAMET Unknown status Tertiary Prevention in Colon Cancer Drug: Aspirin (ASA) + Metformin (MET); Drug: ASA; Drug: MET; Drug: Placebos NF B; pS6K, p53, beta-catenin, PI3K; IL-6, CRP, VEGF and HOMA index; Gene expression levels; Metformin concentration Ente Ospedaliero Ospedali Galliera All 18 Years to 80 Years (Adult, Older Adult) 160 Other Interventional Study Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention 27UCS2015; 2015-004824-77 15/03/2017 15/09/2019 15/03/2020 02/09/2017 15/02/2019 https://ClinicalTrials.gov/show/NCT03047837 Localised/Locoregional Hospital/University/Research Institute Y N N Italy GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid; Metformin Biomarker Phase 2 DB01048; DB00703 N
NCT03675893 Abemaciclib + Letrozole +/- Metformin in Recurrent or Persistent Endometrial Cancer Recruiting Endometrial Cancer Drug: Letrozole; Drug: Abemaciclib; Drug: LY3023414; Drug: Metformin Progression Free Survival Rate; Objective Tumor Response Rate; Overall Survival Rate; Treatment-related toxicities Dana-Farber Cancer Institute; Eli Lilly and Company Female 18 Years and older (Adult, Older Adult) 60 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 18-301 24/12/2018 05/01/2024 05/01/2026 18/09/2018 13/06/2023 https://ClinicalTrials.gov/show/NCT03675893 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Endometrial Cancer Metformin Response rate; PFS Phase 2 DB00703 N
NCT01930864 Metformin Plus Irinotecan for Refractory Colorectal Cancer Unknown status Colorectal Neoplasms|Adenocarcinoma Drug: metformin; Drug: irinotecan Non-Progression at week 12th of treatment; Progression-free survival; Overall Survival; Quality of life; Safety Barretos Cancer Hospital; University of Campinas, Brazil; AC Camargo Cancer Center All 18 Years and older (Adult, Older Adult) 41 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MetIri 09/01/2015 12/01/2020 12/01/2020 29/08/2013 22/06/2017 https://ClinicalTrials.gov/show/NCT01930864 Recurrent/Refractory Hospital/University/Research Institute N N N Brazil GI Colon Cancer; Rectal Cancer Metformin Safety and/or Dose; PFS; OS; QoL Phase 2 DB00703 N
NCT01864096 The Metformin Active Surveillance Trial (MAST) Study MAST Recruiting Prostate Cancer Drug: Metformin; Drug: Placebo Time to progression; Time to primary therapy for prostate cancer; Time to pathological progression; Change from baseline in disease-related patient anxiety; Change from baseline in decisional satisfaction and decisional conflict; Change from baseline in prostate cancer diagnosis at repeat biopsy; Change in Gleason Score at repeat biopsy; Change in clinical stage of prostate cancer based on digital rectal examination; Assess the prognostic and predictive value of prostate cancer biomarkers; To determine the safety and incidence of (serious) adverse events from the administration of 36 months of metformin to men with early stage prostate cancer University Health Network, Toronto Male 18 Years to 79 Years (Adult, Older Adult) 408 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment MAST 01 10/01/2013 08/01/2023 08/01/2024 29/05/2013 19/04/2021 https://ClinicalTrials.gov/show/NCT01864096 Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N Canada Urological Prostate Cancer Metformin Other (specify) Phase 3 DB00703 N
NCT03874000 Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients SMART Unknown status Non Small Cell Lung Cancer Biological: Sintilimab; Drug: Metformin Hydrochloride Objective Response Rate (ORR); Overall Survival (OS); Progress free survival (PFS ; Disease Control Rate (DCR ; Duration of Response (DOR) Tianjin Medical University Cancer Institute and Hospital; Innovent Biologics (Suzhou) Co. Ltd. All 18 Years to 75 Years (Adult, Older Adult) 43 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SMART 03/08/2019 28/02/2022 06/05/2022 14/03/2019 19/03/2019 https://ClinicalTrials.gov/show/NCT03874000 Recurrent/Refractory Hospital/University/Research Institute N N N China Lung Non-Small Cell Lung Cancer Metformin Response rate; PFS; OS Phase 2 DB00703 N
NCT03800602 Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer Active, not recruiting Colorectal Adenocarcinoma|Metastatic Microsatellite Stable Colorectal Carcinoma|Refractory Colorectal Carcinoma|Stage IV Colorectal Cancer|Stage IVA Colorectal Cancer|Stage IVB Colorectal Cancer|Stage IVC Colorectal Cancer|Colorectal Cancer Metastatic Drug: Metformin; Biological: Nivolumab Overall response rate (ORR); Progression free survival (PFS); Overall survival (OS); Biological response: carcinoembryonic antigen (CEA) Emory University; Bristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of Health (NIH) All 18 Years and older (Adult, Older Adult) 24 Other; Industry; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00106678; NCI-2018-02201; Winship4494-18; P30CA138292 15/01/2019 31/01/2024 31/01/2025 01/11/2019 07/05/2023 https://ClinicalTrials.gov/show/NCT03800602 Recurrent/Refractory Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Metformin Response rate; PFS; OS; Biomarker Phase 2 DB00703 N
NCT04033107 High Dose Vitamin C Combined With Metformin in the Treatment of Malignant Tumors Recruiting Hepatocellular Cancer|Pancreatic Cancer|Gastric Cancer|Colorectal Cancer Drug: Vitamin C; Drug: Metformin Progression-free survival; Overall survival; Objective response rate; Disease control rate; Changes of quality of life; Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 Zhongnan Hospital All 18 Years to 70 Years (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ZNCM 07/01/2020 12/01/2024 12/01/2024 25/07/2019 28/09/2023 https://ClinicalTrials.gov/show/NCT04033107 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer Ascorbic acid; Metformin PFS Phase 2 DB00335; DB00703 N
NCT03048500 Nivolumab and Metformin Hydrochloride in Treating Patients With Stage III-IV Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Unknown status Recurrent Non-Small Cell Lung Carcinoma|Stage III Non-Small Cell Lung Cancer|Stage IIIA Non-Small Cell Lung Cancer|Stage IIIB Non-Small Cell Lung Cancer|Stage IV Non-Small Cell Lung Cancer Other: Laboratory Biomarker Analysis; Drug: Metformin Hydrochloride; Biological: Nivolumab Objective Response Rate (ORR) of Patients With Non-small Cell Lung Cancer Treated With Nivolumab and Metformin Combination Using RECIST 1.1; Depth of Response; Duration of Response; Persistence of Response; Disease Control Rate (DCR); Progression-Free Survival (PFS); Overall Survival (OS); Objective Response Rate (ORR) of Patients With Non-small Cell Lung Cancer Treated With Nivolumab and Metformin Combination Using irRECIST.; Incidence of Adverse Events Northwestern University; Bristol-Myers Squibb; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 17 Other; Industry; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NU 16L04; STU00204354; P30CA060553; NCI-2017-00060 07/12/2017 19/09/2019 09/01/2021 02/09/2017 14/10/2020 14/10/2020 https://ClinicalTrials.gov/show/NCT03048500 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Metformin Response rate; PFS Phase 2 DB00703 N
NCT02336087 Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery Active, not recruiting Pancreatic Adenocarcinoma|Unresectable Pancreatic Carcinoma|Stage III Pancreatic Cancer AJCC v6 and v7|Stage IV Pancreatic Cancer AJCC v6 and v7 Drug: Gemcitabine Hydrochloride; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Drug: Metformin Hydrochloride; Dietary Supplement: Therapeutic Dietary Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment Feasibility of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement; Compliance of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (percent of patients who are fully compliant); Toxicity of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (National Cancer Institute Common Terminology for Adverse Events criteria version 4); Progression-free survival; Overall survival; Time to treatment failure City of Hope Medical Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 21 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 14122; NCI-2014-02612 14/01/2016 10/04/2020 31/12/2023 01/12/2015 21/03/2023 https://ClinicalTrials.gov/show/NCT02336087 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Metformin Other (specify) Phase 1 DB00703 N
NCT02294006 Activity and Safety of Everolimus+Octreotide LAR+Metformin in Advanced Pancreatic Well-differentiated NETs MetNET1 Unknown status Well Differentiated Pancreatic Endocrine Tumor Drug: Everolimus plus Octreotide LAR plus Metformin to determine the progression free survival rate (PFS) at 12 months from the first drug administration in patients with advanced pancreatic neuroendocrine tumors; to determine the safety and tolerability of the combination of Everolimus, Octreotide LAR and Metformin as measured according to the National cancer Institute-Common Toxicity Criteria v. 3.0 guidelines; to determine the overall survival of the combination of Everolimus, Octreotide LAR and Metformin.; to determine the response rate of the combination of Everolimus, Octreotide LAR and Metformin.; to determine the biochemical response of the combination of Everolimus, Octreotide LAR and Metformin. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano All 18 Years and older (Adult, Older Adult) 26 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Ist Nazionale Tumori Milano 06/01/2014 06/01/2021 10/01/2021 19/11/2014 09/09/2021 https://ClinicalTrials.gov/show/NCT02294006 Advanced/Metastatic Hospital/University/Research Institute N N N Italy Endocrine Neuroendocrine Tumours Metformin Safety and/or Dose; PFS Phase 2 DB00703 N
NCT04536805 Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin REPAIRGETUGP16 Recruiting Prostate Cancer Drug: Metformin; Radiation: Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy); Radiation: Stereotactic Body Radiation Therapy (SBRT) 36 Gy; Radiation: Stereotactic Body Radiation Therapy (SBRT) 25 Gy For phase 1:. Select the recommended dose for SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy), in combination with Metformin; For phase 2: estimate the efficacy of re-irradiation SBRT in combination with Metformin in terms of biochemical relapse-free survival rate.; Estimate the efficacy of re-irradiation SBRT in combination with Metformin in terms of biochemical relapse-free survival and biochemical response; Estimation of the efficacy of SBRT re-irradiation in combination with Metformin in terms of progression-free survival and overall survival; Evaluation of acute and late genitourinary and gastrointestinal toxicities of the SBRT re-irradiation; Evaluation of Quality of life after SBRT re-irradiation in combination with Metformin; Evaluation of urinary symptoms; Evaluation of erectile function Institut Cancerologie de l'Ouest Male 18 Years and older (Adult, Older Adult) 44 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ICO-2020-01 17/11/2020 11/01/2026 11/01/2028 09/03/2020 30/08/2022 https://ClinicalTrials.gov/show/NCT04536805 Advanced/Metastatic; Recurrent/Refractory Collaborative Group N Y N France Urological Prostate Cancer Metformin Safety and/or Dose; DFS/RFS/EFS Phase 1/2 DB00703 N
NCT03994744 Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC Unknown status Small-cell Lung Cancer|Small Cell Lung Carcinoma|Small Cell Lung Cancer Recurrent|Small Cell Lung Cancer Extensive Stage Drug: PD-1 inhibitor; Drug: Metformin Objective response rate of Sintilimab and Metformin(ORR); Safety of the combination therapy of Sintilimab and Metformin: CTCAE4.03 grading; Median overall survival (OS) time of Sintilimab and Metformin; Median progression free survival(PFS) of Sintilimab and Metformin; Median duration of response (DoR) of Sintilimab and Metformin Hunan Cancer Hospital; Xiangya Hospital of Central South University; Innovent Biologics (Suzhou) Co. Ltd. All 18 Years to 65 Years (Adult, Older Adult) 68 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HNCH-SCLC-2019260 20/08/2019 08/01/2021 07/01/2022 21/06/2019 28/08/2019 https://ClinicalTrials.gov/show/NCT03994744 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China Lung Small Cell Lung Cancer Metformin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00703 N
NCT05023967 Metformin and Nightly Fasting in Women With Early Breast Cancer Recruiting Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Breast Ductal Carcinoma In Situ|Invasive Breast Carcinoma Procedure: Biospecimen Collection; Drug: Extended Release Metformin Hydrochloride; Other: Monitoring; Other: Nutritional Assessment; Other: Short-Term Fasting Frequency of occurrence of dose limiting toxicity; Change in pre-post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC); Difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms; Change in circulating biomarkers; Change of CIP2A-PP2A-GSK3beta-MCL-1 axis in cancer tissue; Change of Ki67 in cancer tissue; Difference of M30; Difference of phosphorylated S6; Physiological distress; Eating habits; Tobacco; Alcohol consumption; Incidence of adverse events; Difference of the area under the curve of glucose levels M.D. Anderson Cancer Center; National Cancer Institute (NCI) Female 18 Years and older (Adult, Older Adult) 120 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention 2021-0901; NCI-2021-08921; B115UCS2019; 2021-000134-34; 2021-09-01; Pending3; MDA20-02-01; UG1CA242609 04/04/2023 20/11/2025 20/11/2025 27/08/2021 23/06/2023 https://ClinicalTrials.gov/show/NCT05023967 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Metformin Safety and/or Dose; Biomarker Phase 2 DB00703 N
NCT04414540 Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients Recruiting Head and Neck Squamous Cell Carcinoma Drug: Metformin Extended Release Oral Tablet; Drug: Pembrolizumab Overall Response by RECIST 1.1 and iRECIST; Number of patients with adverse events measured by CTCAE v5.0; Progression Free Survival (PFS); Overall Survival (OS) Trisha Wise-Draper; American Cancer Society, Inc.; University of Cincinnati All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UCCC-HN-19-01 31/08/2020 07/01/2023 07/01/2024 06/04/2020 10/04/2022 https://ClinicalTrials.gov/show/NCT04414540 Advanced/Metastatic Collaborative Group N Y N United States Head and Neck Any head and neck squamous cell carcinoma Metformin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00703 N
NCT02122185 Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Suspended Brenner Tumor|Malignant Ascites|Malignant Pleural Effusion|Ovarian Clear Cell Cystadenocarcinoma|Ovarian Endometrioid Adenocarcinoma|Ovarian Mixed Epithelial Carcinoma|Ovarian Serous Cystadenocarcinoma|Ovarian Undifferentiated Adenocarcinoma|Recurrent Fallopian Tube Cancer|Recurrent Ovarian Epithelial Cancer|Recurrent Ovarian Germ Cell Tumor|Recurrent Primary Peritoneal Cavity Cancer|Stage IIIA Fallopian Tube Cancer|Stage IIIA Ovarian Epithelial Cancer|Stage IIIA Ovarian Germ Cell Tumor|Stage IIIA Primary Peritoneal Cavity Cancer|Stage IIIB Fallopian Tube Cancer|Stage IIIB Ovarian Epithelial Cancer|Stage IIIB Ovarian Germ Cell Tumor|Stage IIIB Primary Peritoneal Cavity Cancer|Stage IIIC Fallopian Tube Cancer|Stage IIIC Ovarian Epithelial Cancer|Stage IIIC Ovarian Germ Cell Tumor|Stage IIIC Primary Peritoneal Cavity Cancer|Stage IV Fallopian Tube Cancer|Stage IV Ovarian Epithelial Cancer|Stage IV Ovarian Germ Cell Tumor|Stage IV Primary Peritoneal Cavity Cancer Drug: metformin hydrochloride; Drug: placebo; Drug: Chemotherapy Progression free survival (PFS) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria; Time to biochemical (CA-125) progression using GCIG criteria; Overall survival; Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 University of Chicago Female 18 Years and older (Adult, Older Adult) 160 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment IRB13-1235; NCI-2014-00860 25/02/2015 25/02/2025 25/02/2025 24/04/2014 28/08/2023 https://ClinicalTrials.gov/show/NCT02122185 Localised/Locoregional Hospital/University/Research Institute Y N N United States Gynaecological Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer Metformin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00703 N
NCT02946996 Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy Recruiting Prostate Cancer Drug: Metformin; Other: OPC AGE level reduction; Correlation between changes to AGE level and changes to PSA; Correlation between changes to AGE level and changes to BMI; Correlation between changes to AGE level and changes to insulin resistance (HOMA-IR); Correlation between changes to AGE level and changes to A1C.; Correlations between changes to AGE level and changes to testosterone.; Correlation between changes to AGE level and changes to lipids.; Correlation between changes to AGE level and changes to diet.; Correlation between changes to AGE level and changes to quality of life; Frequency of adverse events as assessed by CTCAE v. 4; Correlation between AGE levels and plasma IL6; Correlation between AGE levels and leptin; Correlation between AGE levels and c-reactive protein (CRP); Correlation between AGE levels and malondialdehyde (MDA); Correlation between AGE levels and oxLDLs (low density lipoprotein); Correlation between AGE levels and sRAGE (soluble receptor for AGE) Medical University of South Carolina Male 18 Years and older (Adult, Older Adult) 45 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 102508 28/12/2016 31/12/2023 30/03/2024 27/10/2016 11/01/2023 https://ClinicalTrials.gov/show/NCT02946996 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Prostate Cancer Metformin Biomarker Phase 2 DB00703 N
NCT01797523 A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma Active, not recruiting Endometrial Cancer Drug: Metformin; Drug: Letrozole; Drug: Everolimus Clinical Benefit Rate (CBR); Progression-Free Survival (PFS) M.D. Anderson Cancer Center; Novartis; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 62 Other; Industry; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2012-0543; NCI-2013-00960 10/07/2013 31/10/2025 31/10/2025 22/02/2013 22/09/2023 https://ClinicalTrials.gov/show/NCT01797523 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Endometrial Cancer Metformin PFS; Other (specify) Phase 2 DB00703 N
NCT02365597 An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer Active, not recruiting Urothelial Cancer Drug: Erdafitinib; Drug: Midazolam; Drug: Metformin Main Study: Percentage of Participants With Best (Overall) Objective Response; Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib; Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib; Main Study: Progression-free Survival (PFS); Main Study: Duration of Response (DoR); Main Study: Overall Survival; Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs); Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h); Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h) Janssen Research Development, LLC All 18 Years and older (Adult, Older Adult) 239 Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CR105065; 42756493BLC2001; 2014-002408-26 22/04/2015 15/09/2022 29/12/2023 19/02/2015 10/10/2023 10/10/2023 https://ClinicalTrials.gov/show/NCT02365597 Advanced/Metastatic Company N Y N United States Urological Bladder Cancer Metformin; Midazolam Safety and/or Dose; Response rate; PFS; OS; Biomarker Phase 2 DB00703; DB00834 N
NCT02823691 The MetNET-2 Trial MetNET-2 Unknown status Neuroendocrine Tumors Drug: Lanreotide and Metformin incidence of SAEs and AEs; time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin; symptomatic responses to Lanreotide ATG 120 mg in combination with Metformin in symptomatic patients; biochemical responses to Lanreotide ATG 120 mg in combination with Metformin Fondazione IRCCS Istituto Nazionale dei Tumori, Milano All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NationalCIMilan 04/01/2016 12/01/2021 12/01/2021 07/06/2016 06/07/2021 https://ClinicalTrials.gov/show/NCT02823691 Advanced/Metastatic Collaborative Group N N N Italy Endocrine Neuroendocrine Tumours Metformin Safety and/or Dose; Response rate; Biomarker; Other (specify) Phase 1 DB00703 N
NCT02065687 Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer Unknown status Endometrial Adenocarcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Endometrial Undifferentiated Carcinoma|Recurrent Uterine Corpus Carcinoma|Stage III Uterine Corpus Cancer AJCC v7|Stage IIIA Uterine Corpus Cancer AJCC v7|Stage IIIB Uterine Corpus Cancer AJCC v7|Stage IIIC Uterine Corpus Cancer AJCC v7|Stage IV Uterine Corpus Cancer AJCC v7|Stage IVA Uterine Corpus Cancer AJCC v7|Stage IVB Uterine Corpus Cancer AJCC v7 Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Metformin Hydrochloride; Drug: Paclitaxel; Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration Progression-free Survival (PFS) (Phase II); Overall Survival (OS) (Phase II and III); Proportion of Patients Responding to Therapy; Duration of Response by Treatment; Overall Survival (OS) (Phase II); Progression Free Survival (PFS) (Phase III); Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4; Level of Obesity Gynecologic Oncology Group; National Cancer Institute (NCI); GOG Foundation Female 18 Years and older (Adult, Older Adult) 469 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment GOG-0286B; NCI-2013-02284; s14-01068; U10CA180830; U10CA180868; U10CA027469 17/03/2014 17/04/2019 13/09/2023 19/02/2014 01/12/2021 30/09/2021 https://ClinicalTrials.gov/show/NCT02065687 Advanced/Metastatic; Recurrent/Refractory Collaborative Group Y N N United States Gynaecological Endometrial Cancer Metformin Safety and/or Dose; PFS; OS Phase 2/3 DB00703 N
NCT02978547 The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma Metformin 001 Unknown status Resectable Pancreatic Ductal Adenocarcinoma Drug: Metformin Hydrochloride 500Mg Tablet The effect of neoadjuvant metformin treatment on tumour cell proliferation in PDAC tumours; R0 resection rates in patients undergoing curative PDAC resection; The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting GGT (mmol/L); The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting glucose (mmol/L); The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting insulin (mU/L); The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index; The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg); The effect of metformin on metabolomic profile of pre- and post-metformin samples; Transcriptome sequencing (RNAseq) of pre- and post-treatment tumour samples.; Plasma ctDNA, measured as percentage of mutant to total DNA fragments in plasma; Correlation between imaging and pathologic parameters British Columbia Cancer Agency; Pancreatic Cancer Canada; BC Cancer Foundation All 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H16-02566 01/01/2019 06/01/2020 01/01/2021 12/01/2016 18/01/2018 https://ClinicalTrials.gov/show/NCT02978547 Localised/Locoregional Collaborative Group N N N Canada GI Pancreatic Cancer Metformin Biomarker; Other (specify) Phase 2 DB00703 N
NCT02186847 Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer Active, not recruiting Adenosquamous Lung Carcinoma|Bronchioloalveolar Carcinoma|Large Cell Lung Carcinoma|Lung Adenocarcinoma|Non-Small Cell Lung Carcinoma|Recurrent Non-Small Cell Lung Carcinoma|Squamous Cell Lung Carcinoma|Stage IIIA Non-Small Cell Lung Cancer|Stage IIIB Non-Small Cell Lung Cancer Radiation: Radiation Therapy; Drug: Carboplatin; Drug: Metformin; Drug: Paclitaxel Percentage of Participants Alive Without Progression (Progression-free Survival); Percentage of Participants Alive (Overall Survival); Percentage of Participants With Local-regional Progression; Percentage of Participants With Distant Metastases; Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events NRG Oncology; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 170 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NRG-LU001; NCI-2014-01071; PNRG-LU001_A01PAMDREVW01; U10CA180868 08/01/2014 16/04/2019 16/04/2024 07/10/2014 23/06/2020 22/06/2023 https://ClinicalTrials.gov/show/NCT02186847 Localised/Locoregional Collaborative Group Y N N United States Lung Non-Small Cell Lung Cancer Metformin Safety and/or Dose; PFS; OS; Recurrence rate Phase 2 DB00703 N
NCT05929495 Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma Not yet recruiting Glioblastoma, IDH-wildtype|Metformin|Malignancies Drug: Metformin Value of PFS at 6 months after the start of treatment; EORTC QLQ-C30 questionnaire at 6 months after the start of treatment; MMSE questionnaire at 6 months after the start of treatment; Safety and tolerability assessment of treatment; Plasma measurement of circulating metabolites; Plasma measurement of adiponectin; Proteomic analysis; Correlations between in vivo clinical response and effect of association measured in vitro on cell lines obtained from the same patient undergoing surgery; Gene expression analysis University of Milano Bicocca All 18 Years and older (Adult, Older Adult) 25 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GBM MET 12/01/2023 01/01/2026 01/01/2026 07/03/2023 11/09/2023 https://ClinicalTrials.gov/show/NCT05929495 Localised/Locoregional Hospital/University/Research Institute N N N Italy CNS Glioblastoma Metformin Safety and/or Dose; PFS; QoL; Biomarker Phase 2 DB00703 N
NCT03311308 A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma Recruiting Advanced Melanoma Drug: Pembrolizumab Injection [Keytruda]; Drug: Metformin Ki-67 proliferation index in T cell; Number of participants experiencing adverse events; Hypoxia in the primary tumor by IHC Staining; Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by mitochondrial mass; Cell cycle status of peripheral blood T lymphocytes by Flow Cytometry; overall tumor response rate; Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by Seahorse metabolic profiling Yana Najjar; Merck Sharp Dohme LLC; University of Pittsburgh All 18 Years and older (Adult, Older Adult) 30 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 16-196 02/07/2018 01/01/2026 12/01/2027 17/10/2017 14/04/2023 https://ClinicalTrials.gov/show/NCT03311308 Localised/Locoregional; Advanced/Metastatic Company Y N N China Skin Melanoma Metformin Safety and/or Dose; Biomarker Phase 1 DB00703 N
NCT02437812 Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma Unknown status Epithelial Ovarian Carcinoma Drug: Metformin; Drug: Paclitaxel; Drug: Carboplatin Progression free survival; Metabolic biomarker evaluation Gynecologic Oncology Associates; University of North Carolina, Chapel Hill Female 18 Years and older (Adult, Older Adult) 30 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GOA-TCOM1 01/01/2014 10/01/2017 04/01/2021 05/08/2015 28/02/2017 https://ClinicalTrials.gov/show/NCT02437812 Advanced/Metastatic Collaborative Group N N N United States Gynaecological Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer Metformin PFS; Biomarker Phase 2 DB00703 N
NCT05316935 GnRHa + Letrozole in Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients Recruiting Endometrial Neoplasms|Atypical Endometrial Hyperplasia|Progesterone Resistance Drug: GnRHa; Drug: Letrozole 2.5mg; Drug: Diane-35; Drug: MET Complete response rates within 28 weeks of treatment; Adverse events; Time to achieve complete response; Relapse rates; Rates of fertility outcomes; Compliance Xiaojun Chen; Fudan University Female 18 Years to 45 Years (Adult) 118 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 53211030 13/07/2022 30/03/2025 30/03/2025 04/07/2022 21/02/2023 https://ClinicalTrials.gov/show/NCT05316935 Localised/Locoregional Hospital/University/Research Institute N Y N China Gynaecological Endometrial Cancer Metformin Safety and/or Dose; Response rate; Other (specify) Phase 2/3 DB00703 N
NCT05854966 CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) Not yet recruiting Acute Myeloid Leukemia, in Relapse|Acute Myeloid Leukemia Refractory|Granulocytic Sarcoma Drug: CPI 613; Drug: Metformin; Biological: Blood draws; Procedure: Bone marrow biopsy Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility; Response Rate - Efficacy (Acute Myeloid Leukemia European LeukemiaNet 2022); Overall Survival; Number of Reported Adverse Events - Safety Wake Forest University Health Sciences; National Cancer Institute (NCI); Cornerstone Pharmaceuticals All 18 Years and older (Adult, Older Adult) 17 Other; NIH; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment WFBCCC 22323; P30CA012197 02/01/2024 10/01/2024 09/01/2025 05/11/2023 29/11/2023 https://ClinicalTrials.gov/show/NCT05854966 Recurrent/Refractory Hospital/University/Research Institute N N N United States Leukemia Acute Myeloid Leukemia, Adult Metformin Other (specify) Phase 2 DB00703 N
NCT05759312 Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma Not yet recruiting Ovarian Clear Cell Carcinoma Drug: Zimberelimab; Drug: Metformin Hydrochloride Objective response rate; Progression-free survival; Overall survival; Disease control rate; Duration of response; Number of participants with treatment-related adverse events as assessed by CTCAE v5.0; Patterns of subsequent recurrence Fudan University Female 18 Years to 75 Years (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment zsfud-OC-001 03/01/2023 02/01/2025 02/01/2025 03/08/2023 03/08/2023 https://ClinicalTrials.gov/show/NCT05759312 Recurrent/Refractory Hospital/University/Research Institute N N N China Gynaecological Ovarian - Other Metformin Response rate Phase 1/2 DB00703 N
NCT03618654 Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma Active, not recruiting Head and Neck Squamous Cell Carcinoma|Oral Cavity Squamous Cell Carcinoma|Oropharyngeal Squamous Cell Carcinoma Drug: Metformin; Biological: Durvalumab Immune cell polarization (Th1/Th2; M1/M2); Alterations in immunohistochemical (IHC) markers; Alterations in intratumoral immune cell populations; Changes of the intratumoral immunophenotype and metabolism after exposure to durvalumab and metformin; Tumor size as measured by immune-related response criteria (irRC) Sidney Kimmel Cancer Center at Thomas Jefferson University; Thomas Jefferson University All 18 Years and older (Adult, Older Adult) 38 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 18P.389 11/01/2018 20/11/2021 10/01/2023 08/07/2018 16/08/2022 https://ClinicalTrials.gov/show/NCT03618654 Localised/Locoregional Hospital/University/Research Institute Y N N United States Head and Neck Any head and neck squamous cell carcinoma Metformin Biomarker Phase 1 DB00703 N
NCT05326984 Effect of Metformin on ABCB1 and AMPK Expression in Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia Recruiting Acute Lymphoblastic Leukemia Drug: Metformin Decrease of ABCB1 gene expression; Increase of AMPK gene expression; Overall survival; Event free survival Hospital General de Mexico All 10 Years to 21 Years (Child, Adult) 20 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science DI/21/505/03/10 02/09/2021 12/01/2023 12/01/2023 14/04/2022 14/04/2022 https://ClinicalTrials.gov/show/NCT05326984 Localised/Locoregional Hospital/University/Research Institute Y N Y Mexico Leukemia Acute Lymphoblastic Leukemia, Childhood; Acute Lymphoblastic Leukemia, Adult Metformin OS; DFS/RFS/EFS; Biomarker Other DB00703 N
NCT04758000 Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse Metform-Bone Recruiting Osteosarcoma|Ewing Sarcoma Drug: Metformin Hydrochloride Event Free Survival; Metformin toxicity Istituto Ortopedico Rizzoli All 14 Years and older (Child, Adult, Older Adult) 67 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention 794/2020/Farm/IOR; 2020-002579-37 03/01/2021 07/01/2027 07/01/2027 17/02/2021 08/04/2023 https://ClinicalTrials.gov/show/NCT04758000 Localised/Locoregional Hospital/University/Research Institute N N N Italy Bone Sarcoma Ewing Sarcoma; Osteosarcoma Metformin DFS/RFS/EFS Phase 2 DB00703 N
NCT02780024 Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM Active, not recruiting Glioblastoma Multiforme Drug: Metformin Number of patients completing the study treatment; To assess toxicity of the regimen McGill University Health Centre/Research Institute of the McGill University Health Centre All 18 Years and older (Adult, Older Adult) 50 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MUHC ID: 4315 03/01/2015 20/10/2021 28/02/2026 23/05/2016 24/10/2023 https://ClinicalTrials.gov/show/NCT02780024 Localised/Locoregional Hospital/University/Research Institute N N N Canada CNS Glioblastoma Metformin Safety and/or Dose; Other (specify) Phase 2 DB00703 N
NCT03833466 Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo) ECMTPneo Unknown status Esophageal Squamous Cell Carcinoma Drug: metformin and chemotherapy Tumor metabolic pathway; Tumor microenvironment; Rate of pathologic complete response pCR Peking University All 18 Years to 70 Years (Adult, Older Adult) 15 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ESCC-MTPneo 02/05/2019 20/03/2020 20/06/2020 02/07/2019 15/02/2019 https://ClinicalTrials.gov/show/NCT03833466 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Esophageal Cancer Metformin Response rate; Biomarker Phase 2 DB00703 N
NCT01638676 A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients Recruiting Melanoma Drug: Vemurafenib; Drug: Metformin Observation of CTCAE grade 4 or higher adverse events in six patients; Overall Survival Follow up; Number of adverse events; type of adverse events; Objective response rate (ORR)as measure of efficacy University of Louisville; James Graham Brown Cancer Center All 18 Years and older (Adult, Older Adult) 55 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BCC-MEL-11-03 07/01/2012 06/01/2025 06/01/2027 07/12/2012 29/10/2021 https://ClinicalTrials.gov/show/NCT01638676 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Metformin Safety and/or Dose Phase 1/2 DB00703 N
NCT04691960 A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging Recruiting Glioblastoma Other: Ketogenic Diet; Drug: Metformin Ability to achieve and maintain ketosis; Tolerability of metformin Weill Medical College of Cornell University All 18 Years and older (Adult, Older Adult) 36 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1604017166 08/01/2016 12/01/2024 12/01/2024 31/12/2020 14/09/2023 https://ClinicalTrials.gov/show/NCT04691960 Localised/Locoregional Hospital/University/Research Institute N N N Belgium CNS Medulloblastoma; Glioblastoma; Astrocytoma; Glioma Metformin Safety and/or Dose; Biomarker Phase 2 DB00703 N
NCT01750567 A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL Active, not recruiting Relapsed Chronic Lymphocytic Leukemia Drug: Metformin Time to treatment failure; Time to first therapy (TTFT) in previously untreated 11q CLL subsets only.; Changes in the rate of increase of absolute lymphocyte count while on metformin therapy; Change in size of clinically appreciated lymphadenopathy in cm and splenomegaly while on metformin therapy; Change in number of clinically appreciated lymphadenopathy and splenomegaly while on metformin therapy University of Michigan Rogel Cancer Center All 18 Years to 80 Years (Adult, Older Adult) 37 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UMCC 2012.025 11/01/2012 05/01/2024 05/01/2024 17/12/2012 31/08/2023 https://ClinicalTrials.gov/show/NCT01750567 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States Leukemia Chronic Lymphocytic Leukemia Metformin Biomarker; Other (specify) Phase 2 DB00703 N
NCT05183204 Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma Recruiting Glioblastoma Drug: Paxalisib; Drug: Metformin; Other: Ketogenic Diet Progression-free survival, defined as the survival rate at 6 months; Overall survival, defined as the time of first study treatment to death from any cause; Change in insulin levels; Change in tumor glucose uptake values Weill Medical College of Cornell University; Kazia Therapeutics Limited All 18 Years and older (Adult, Older Adult) 33 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 21-05023537 14/02/2022 12/01/2024 12/01/2025 01/10/2022 26/09/2023 https://ClinicalTrials.gov/show/NCT05183204 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma Metformin PFS; OS; Biomarker Phase 2 DB00703 N
NCT03600363 A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients Unknown status Lymphoma, Large B-Cell, Diffuse|Stage III Follicular Lymphoma Drug: Metformin; Drug: Placebos Overall Survival; Progress Free Survival Ruijin Hospital All 14 Years and older (Child, Adult, Older Adult) 250 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment RJ-NHL-1805 09/01/2018 01/01/2021 12/01/2021 26/07/2018 03/11/2020 https://ClinicalTrials.gov/show/NCT03600363 Localised/Locoregional Hospital/University/Research Institute N N Y China Lymphoma Non-Hodgkin Lymphoma, Adult; Non-Hodgkin Lymphoma, Childhood Metformin PFS; OS Phase 2 DB00703 N
NCT04264676 Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer Recruiting Colorectal Cancer Stage II|Colorectal Cancer Stage III Drug: Metronidazole Oral Tablet; Drug: Placebo oral tablet Disease Free Survival, DFS; Overall Survival, OS; Recurrence Rate, RR Shanghai Jiao Tong University School of Medicine; Shanghai Municipal Commission of Health and Family Planning; Ruijin Hospital; Fudan University; Shanghai Zhongshan Hospital; Shanghai Shenkang Hospital Development Center All 18 Years to 75 Years (Adult, Older Adult) 294 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment KY2019-066 31/03/2020 03/01/2023 03/01/2025 02/11/2020 25/11/2020 https://ClinicalTrials.gov/show/NCT04264676 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metronidazole OS; DFS/RFS/EFS; Recurrence rate Phase 1 DB01011 N
NCT05720559 Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection Not yet recruiting Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer Drug: Oxaliplatin; Drug: S1; Drug: Cetuximab; Drug: Metronidazole; Drug: Vitamin A; Drug: Folic acid; Drug: Capecitabine Metachronous liver metastasis rate; Overall Survival (OS) Liaoning Tumor Hospital Institute All 18 Years to 80 Years (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20230201zzg 03/01/2023 03/01/2026 09/01/2026 02/09/2023 02/09/2023 https://ClinicalTrials.gov/show/NCT05720559 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metronidazole OS; Other (specify) Phase 2 DB01011 N
NCT05774964 Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases Not yet recruiting For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method Drug: Oxaliplatin; Drug: S1; Drug: Cetuximab; Drug: Metronidazole; Drug: Vitamin A; Drug: Folic acid Overall Response Rate (ORR); Overall Survival (OS); Progression Free Survival (PFS) Liaoning Tumor Hospital Institute All 18 Years to 80 Years (Adult, Older Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20230303zzg 15/03/2023 15/03/2025 15/03/2025 20/03/2023 20/03/2023 https://ClinicalTrials.gov/show/NCT05774964 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metronidazole Response rate; PFS; OS Phase 2 DB01011 N
NCT03225547 Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer Active, not recruiting Triple Negative Breast Neoplasms|Breast Cancer Drug: Pembrolizumab; Drug: Mifepristone Rate of overall response based on RECIST 1.1; Number of patients with adverse events; Rate of overall response based on irRECIST University of Chicago All 18 Years and older (Adult, Older Adult) 74 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB17-0721 02/12/2018 09/01/2025 09/01/2025 21/07/2017 28/04/2023 https://ClinicalTrials.gov/show/NCT03225547 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - HER2- Mifepristone Safety and/or Dose; Response rate Phase 2 DB09031 N
NCT02788981 Abraxane With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer Active, not recruiting Breast Cancer Drug: Mifepristone; Other: Placebo; Drug: Nab-Paclitaxel Progression-free survival (PFS); Response rate in glucocorticoid receptor (GR) positivity; Response Rate; Overall survival University of Chicago All 18 Years and older (Adult, Older Adult) 64 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment IRB16-0403 28/03/2017 21/12/2022 08/01/2024 06/02/2016 02/02/2023 https://ClinicalTrials.gov/show/NCT02788981 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Breast Cancer - TNBC Miltefosine Response rate; PFS; OS; Biomarker Phase 2 DB01017 N
NCT03256916 Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix NELCER Recruiting Carcinoma Cervix,Stage III Drug: Nelfinavir; Drug: Cisplatin; Radiation: Pelvic EBRT and Brachytherapy Improvement in 3 year disease free survival; Change in locoregional control rates at 3 years; Overall survival at 5 years; Incidence of grade 3/4 adverse events; Changes in Akt levels in the tumor; Change in tumour hypoxia using multifunctional PET/ MRI.; Interindividual variability of Volume of distribution; Interindividual variability of Clearance of nelfinavir.; Interindividual variability of Clearence of Nelfinavir Tata Memorial Hospital Female 18 Years to 65 Years (Adult, Older Adult) 348 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment TMH Project 1543 16/01/2018 30/09/2025 30/09/2025 22/08/2017 21/02/2022 https://ClinicalTrials.gov/show/NCT03256916 Primary/Main Curative Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N India Gynaecological Cervical Cancer Nelfinavir Safety and/or Dose; OS; DFS/RFS/EFS; Biomarker Phase 3 DB00622 N
NCT04337580 Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer FASN Recruiting Prostate Cancer|Refractory Cancer|Castration Resistant Prostatic Cancer Drug: Omeprazole 80 mg twice daily Change Radiographic Response - RECIST 1.1; Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3); Fatty Acid Synthase Activity - Pre Omeprazole Use; Fatty Acid Synthase Activity - Post Omeprazole Use; Prostate Specific Antigen (PSA) Progression; Prostate Specific Antigen (PSA) Response; Patient Reported Outcome - Pain Wake Forest University Health Sciences; National Cancer Institute (NCI) Male 18 Years and older (Adult, Older Adult) 20 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00068039; P30CA012197; WFBCC 85220 03/05/2021 08/01/2024 09/01/2024 04/07/2020 26/10/2023 https://ClinicalTrials.gov/show/NCT04337580 Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Prostate Cancer Omeprazole QoL; Biomarker Phase 2 DB01083 N
NCT02950259 Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) Unknown status Breast Neoplasm|Breast Neoplasm, Male|Triple Negative Breast Cancer Drug: Cyclophosphamide; Drug: Indomethacin; Drug: Omeprazole; Dietary Supplement: Multivitamin Surgical Delays; Tumor Infiltrating Lymphocytes Providence Health Services; Brooklyn ImmunoTherapeutics, LLC All Child, Adult, Older Adult 16 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 16-126B; IRX-2 2016-B 02/09/2017 10/01/2022 01/01/2023 11/01/2016 02/02/2022 https://ClinicalTrials.gov/show/NCT02950259 Localised/Locoregional Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Indomethacin; Omeprazole Safety and/or Dose Phase 1 Not found in DrugBank; DB01083 N
NCT01871454 Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers Recruiting Non-small Cell Lung Cancers Radiation: stereotactic ablative radiotherapy (SABR); Drug: Pentoxifylline primary endpoint is to estimate overall treatment-related toxicity; Estimate progression free survival; Estimate tumor failure; estimate overall survival University of Louisville; James Graham Brown Cancer Center All 18 Years and older (Adult, Older Adult) 59 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BCC-RAD-13-Pentoxifylline 10/01/2013 12/01/2022 12/01/2025 06/06/2013 22/06/2021 https://ClinicalTrials.gov/show/NCT01871454 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Pentoxifylline Safety and/or Dose; PFS; OS Phase 2 DB08883 N
NCT05490953 Enhancing Effect on Tumour Apoptosis With the Use of Pentoxifylline in Patients With Hodgkin Lymphoma Recruiting Hodgkin Lymphoma Drug: Pentoxifylline; Drug: Placebo Peripheral apoptosis (Fortilin); Peripheral apoptosis (Cytochrome c); Assessment of the clinical response by positron emission tomography (PET); Assessment of the clinical response by Computerized Axial Tomography; Assessment of the clinical response; Determination of event-free survival; Assessment of the severity of adverse effects; Correlation of adverse effects with pentoxifylline University of Guadalajara; Hospital Civil de Guadalajara All 6 Years to 35 Years (Child, Adult) 30 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment CI-03122 07/11/2022 31/12/2023 07/01/2024 08/08/2022 18/04/2023 https://ClinicalTrials.gov/show/NCT05490953 Any/All Stages Hospital/University/Research Institute Y N Y Mexico Lymphoma Hodgkin Lymphoma, Adult; Hodgkin Lymphoma, Childhood Pentoxifylline Safety and/or Dose; DFS/RFS/EFS; Biomarker Phase 4 DB08883 N
NCT04794127 Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone. TRABEPIO Recruiting Liposarcoma, Myxoid|Liposarcoma, Dedifferentiated|Liposarcoma, Round Cell Drug: Trabectedin; Drug: Pioglitazone Oral Product Objective response (OR) in patients with myxoid liposarcomas according to RECIST criteria or CHOI criteria; Number and severity of Adverse Events; Maximum Plasma Concentration [Cmax] Mario Negri Institute for Pharmacological Research; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Humanitas Hospital, Italy All 18 Years and older (Adult, Older Adult) 10 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRFMN-SARCO-7953 02/02/2022 02/02/2024 02/02/2024 03/11/2021 26/10/2023 https://ClinicalTrials.gov/show/NCT04794127 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Italy Soft Tissue Sarcoma Liposarcoma Pioglitazone Response rate Phase 2 DB04951 N
NCT02889003 Second STOP After Pioglitazone Priming in CML Patients PIO2STOP Unknown status Chronic Myeloid Leukemia (CML) Drug: Pioglitazone + TKI Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation. Versailles Hospital; Pr Philippe ROUSSELOT All 18 Years and older (Adult, Older Adult) 26 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment P16/05_PIO2STOP 12/01/2016 12/01/2021 12/01/2021 09/05/2016 22/03/2018 https://ClinicalTrials.gov/show/NCT02889003 Localised/Locoregional Hospital/University/Research Institute N N N France Leukemia Chronic Myelogenous Leukemia Pioglitazone Safety and/or Dose; Other (specify) Phase 2 DB04951 N
NCT05544019 Study of SGR-1505 in Mature B-Cell Neoplasms Recruiting Mature B-Cell Neoplasm|Non Hodgkin Lymphoma|DLBCL|Waldenstrom Macroglobulinemia|MALT Lymphoma|Follicular Lymphoma|Pediatric-Type Follicular Lymphoma|IRF4 Gene Rearrangement|EBV-Positive DLBCL, Nos|Burkitt Lymphoma|Plasmablastic Lymphoma|High-grade B-cell Lymphoma|Primary Cutaneous Follicle Center Lymphoma|Primary Effusion Lymphoma|Mantle Cell Lymphoma|DLBCL Germinal Center B-Cell Type|Primary Mediastinal Large B Cell Lymphoma|T-Cell/Histiocyte Rich Lymphoma|ALK-Positive Large B-Cell Lymphoma|Primary Cutaneous Diffuse Large B-Cell Lymphoma|Splenic Marginal Zone Lymphoma|Chronic Lymphocytic Leukemia|Nodal Marginal Zone Lymphoma|HHV8-Positive DLBCL, Nos|Lymphoplasmacytic Lymphoma|Duodenal-Type Follicular Lymphoma Drug: SGR-1505 Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.; Nature and number of incidences of dose limiting toxicity (DLT).; SGR-1505 Maximal Plasma Concentration (Cmax); SGR-1505 Time to Maximal Plasma Concentration (tmax); SGR-1505 Area Under the Concentration Versus Time Curve (AUC); Effect of Food on the Cmax of SGR-1505; Effect of Food on the tmax of SGR-1505; Effect of Food on the AUC of SGR-1505; Effect of Posaconazole on the Cmax of SGR-1505; Effect of Posaconazole on the tmax of SGR-1505; Effect of Posaconazole on the AUC of SGR-1505; Objective Response Rate (ORR); Duration of Response (DOR); Disease Control Rate Schr dinger, Inc. All 18 Years and older (Adult, Older Adult) 52 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SGR-1505-101 04/10/2023 03/01/2025 03/01/2025 16/09/2022 01/12/2024 https://ClinicalTrials.gov/show/NCT05544019 Recurrent/Refractory Company N N N United States Leukemia Leukemia - Other Posaconazole Safety and/or Dose Phase 1 DB00175 N
NCT05606692 Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics) anesthetics Recruiting Ovarian Cancer Drug: Propofol 1 ; Drug: Sevoflurane/Ultane progression-free survival; 6-month overall survival; 1-year overall survival; 3-year overall survival; 5-year overall survival; Karnofsky performance score; postoperative complications Kaohsiung Medical University Chung-Ho Memorial Hospital; Tri-Service General Hospital Female 20 Years to 80 Years (Adult, Older Adult) 416 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment KMUHIRB-F(II)-20220157 23/11/2022 30/09/2026 30/09/2027 11/07/2022 30/05/2023 https://ClinicalTrials.gov/show/NCT05606692 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan Gynaecological Ovarian Epithelial Cancer Propofol PFS Phase 4 DB00571 N
NCT05141877 Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor anesthetics Recruiting Brain Tumor Drug: Propofol; Drug: Sevoflurane Overall survival; The presence of disease progression; Karnofsky performance status score; Postoperative complications within 30 days Kaohsiung Medical University Chung-Ho Memorial Hospital; Tri-Service General Hospital All 20 Years to 80 Years (Adult, Older Adult) 706 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment KMUHIRB-F(II)-20210167 18/02/2022 30/11/2024 30/11/2025 12/02/2021 31/10/2023 https://ClinicalTrials.gov/show/NCT05141877 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Other multiple cancer group (specify) Propofol PFS; OS Phase 4 DB00571 N
NCT04475705 Propofol vs Sevo for Paediatric Tumor Surgery Recruiting Solid Tumor|Carcinoma|Malignancy|Cancer Drug: propofol; Drug: sevoflurane difference in Hypoxia Inducible Factor-1 gene expression; difference in levels of Interleukin-6; difference in levels of Tumor Necrosis Factor-alpha; difference in levels of high sensitivity C reaction protein; difference in levels of DNA damage (Comet Assay); difference in levels of Glutathione Peroxidase; difference in levels of Superoxide dismutase; difference in levels of urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG); difference in levels of 8-oxo-7,8-dihydroguanosine (8-oxoGuo); difference in the quantity of circulating tumor cells (CTC); cancer free survival at 1 and 3 years Hong Kong Children's Hospital; The University of Hong Kong All 6 Months to 18 Years (Child, Adult) 100 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment HKCH-REC-2020-013 01/11/2021 07/01/2028 07/01/2028 17/07/2020 16/03/2022 https://ClinicalTrials.gov/show/NCT04475705 Localised/Locoregional Hospital/University/Research Institute Y N Y Hong Kong Multiple cancer types Any solid tumours Propofol Biomarker Phase 4 DB00571 N
NCT03447691 Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery Unknown status Pancreatic Cancer or Distal CBD Cancer Drug: Des (volatile anesthetic-desflurane); Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil) score of QoR40 (Quality of Recovery 40) Yonsei University All 20 Years and older (Adult, Older Adult) 132 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Other 4-2017-0662 27/08/2017 28/08/2022 28/08/2022 27/02/2018 01/11/2019 https://ClinicalTrials.gov/show/NCT03447691 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Pancreatic Cancer; Cholangiocaricnoma Propofol Other (specify) Other DB00571 N
NCT04259398 Anesthesia and Cancer Study: Colon Cancer Active, not recruiting Cancer of Colon|Anesthesia Drug: Propofol; Drug: Sevoflurane five year survival; five year recurrence free survival; 1 year recurrence free survival; 3 year recurrence free survival; 1 year survival; 3 year survival Seoul National University Hospital; Korean Society of Anesthesiologists; Bundang Seoul National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Seoul St. Mary's Hospital; Seoul National University Boramae Hospital All 19 Years to 80 Years (Adult, Older Adult) 797 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Prevention Ane-Can colon (1912-133-109) 18/02/2020 05/03/2028 05/03/2028 02/06/2020 22/11/2023 https://ClinicalTrials.gov/show/NCT04259398 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Colon Cancer Propofol DFS/RFS/EFS Other DB00571 N
NCT03034096 General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial GA-CARES Active, not recruiting Anesthesia, General|Surgical Oncology Drug: Propofol; Drug: Volatile Agent All-cause mortality; Recurrence free survival; All-cause mortality as a binary outcome Stony Brook University All 18 Years and older (Adult, Older Adult) 1804 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment 967670-3 31/01/2017 09/01/2024 12/01/2024 27/01/2017 17/10/2022 https://ClinicalTrials.gov/show/NCT03034096 Localised/Locoregional Hospital/University/Research Institute Y N N United States Multiple cancer types Multiple cancer types Propofol DFS/RFS/EFS Phase 4 DB00571 N
NCT05926336 The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action Recruiting Lung Cancer|Brain Tumor|Liver Cancer|Ovarian Cancer Drug: Propofol; Drug: Sevoflurane Overall survival; The presence of disease progression; Postoperative complications; Karnofsky performance status score; Length of hospital stays Kaohsiung Medical University Chung-Ho Memorial Hospital All 20 Years to 80 Years (Adult, Older Adult) 1316 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment KMUHIRB-F(I)-20230075 23/05/2023 07/01/2026 07/01/2026 07/03/2023 28/09/2023 https://ClinicalTrials.gov/show/NCT05926336 Localised/Locoregional Hospital/University/Research Institute N N N Taiwan Multiple cancer types Multiple cancer types Propofol OS; Other (specify) Phase 4 DB00571 N
NCT04513808 Total Intravenous Anesthesia and Recurrence Free Survival Recruiting Esophageal Cancer Drug: Propofol-based total intravenous anesthesia; Drug: Sevoflurane intravenous anesthesia Recurrence-free survival; ICU duration; Hospital duration; QoR-15 The Cleveland Clinic All 18 Years to 90 Years (Adult, Older Adult) 1614 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment VICTORY 15/08/2020 12/01/2025 12/01/2027 14/08/2020 15/11/2023 https://ClinicalTrials.gov/show/NCT04513808 Localised/Locoregional Hospital/University/Research Institute Y N N United States Multiple cancer types Any solid tumours Propofol DFS/RFS/EFS Phase 3 DB00571 N
NCT04962672 Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study Recruiting Anesthesia|Brain Cancer|Survival Drug: Propofol group; Drug: Sevoflurane group Rate of recruitment; retention rate; rate of protocol adherence; Overall survival; Progression free survival University Health Network, Toronto All 18 Years and older (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Supportive Care 21-5527.0 01/01/2022 06/01/2024 30/12/2024 15/07/2021 22/08/2023 https://ClinicalTrials.gov/show/NCT04962672 Localised/Locoregional Hospital/University/Research Institute Y N N Canada CNS Glioblastoma Propofol PFS; OS; Other (specify) Other DB00571 N
NCT04800393 The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial. TeMP Recruiting Anesthesia|Breast Cancer Drug: Sevoflurane; Drug: Propofol Neutrophil-lymphocyte ratio; Matrix metallopeptidase 9; C-reactive protein; Natural killer cells of blood (CD3-CD16 +); Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +); IL-6 Moscow Clinical Scientific Center; Negovsky Reanimatology Research Institute Female 45 Years to 74 Years (Adult, Older Adult) 130 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Prevention TeMP 2021 29/03/2022 07/01/2023 04/01/2028 16/03/2021 26/04/2023 https://ClinicalTrials.gov/show/NCT04800393 Localised/Locoregional Hospital/University/Research Institute Y N N Russian Federation Breast Any Breast Cancer Propofol Biomarker Other DB00571 N
NCT05663242 The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action Recruiting Lung Cancer|Progression, Disease|Anesthesia Drug: Propofol; Drug: Sevoflurane Overall survival; The presence of disease progression; Postoperative complications; Karnofsky performance status score; Length of hospital stays Kaohsiung Medical University Chung-Ho Memorial Hospital All 20 Years to 80 Years (Adult, Older Adult) 300 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment KMUHIRB-F(I)-20210218. 27/12/2022 30/11/2026 30/11/2026 23/12/2022 30/05/2023 https://ClinicalTrials.gov/show/NCT05663242 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan Lung Any lung cancers Propofol PFS; OS Phase 4 DB00571 N
NCT04601961 Effects of TIVA Versus Inhalational Anaesthesia on Circulating Tumour Cells in Hepatocellular Carcinoma Patients Recruiting Circulating Tumor Cell|Hepatocellular Carcinoma Drug: Propofol; Drug: Sevoflurane HIF-1 gene expression; Change in number of recurrence; Level of Gene expression; Level of DNA damage; Level of C-reactive protein; Level of Glutathione Peroxidase; Level of Superoxide dismutase; Level of Oxidative damage DNA; Level of tumor necrosis factor; Number of Circulating tumour cells The University of Hong Kong All 18 Years to 80 Years (Adult, Older Adult) 220 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Health Services Research UW 20-022 03/04/2020 31/01/2024 31/03/2024 26/10/2020 31/03/2023 https://ClinicalTrials.gov/show/NCT04601961 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Propofol Recurrence rate; Biomarker Other DB00571 N
NCT06017141 Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study Recruiting Colon Adenocarcinoma Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Fentanyl Citrate; Drug: Propofol; Other: Questionnaire Administration; Drug: Sevoflurane; Procedure: Surgical Procedure Neutrophil extracellular traps (NET) formation; Early post-operative recovery; Global and post-operative recovery; Post-operative nausea scores; Number and cumulative amount of doses of anti-emetics; Total hospital opioid use; Patient-reported pain scores; Number of times a pro re nata (PRN) medication administered; First post-op day when participant tolerates a regular diet (at the discretion of the surgical team); Time from study entry and from surgery to disease recurrence, death, or loss to follow up; Post-operative complications; Post-operative immune suppression; Circulating tumor deoxyribonucleic acid (ctDNA); Changes in gene expression University of Kansas Medical Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 80 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment STUDY00149314; NCI-2023-05587; IIT-2022-VIVA; P30CA168524 22/05/2023 22/05/2025 22/05/2026 30/08/2023 30/08/2023 https://ClinicalTrials.gov/show/NCT06017141 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Colon Cancer Propofol OS; Recurrence rate; Biomarker Phase 2 DB00571 N
NCT04503148 Anesthesia and Cancer Study: Renal Cell Carcinoma Active, not recruiting Renal Cell Carcinoma Drug: Propofol; Drug: Inhaled General Anesthetics one year metastasis-free survival; three year metastasis-free survival; one year survival; three year survival Seoul National University Hospital All 18 Years and older (Adult, Older Adult) 562 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Prevention Ane-Can Nx 22/09/2020 22/12/2022 22/12/2025 08/07/2020 14/04/2023 https://ClinicalTrials.gov/show/NCT04503148 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of Urological Renal Cell Carcinoma Propofol OS; Other (specify) Other DB00571 N
NCT05331911 Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors Recruiting Hepatocellular Carcinoma Drug: Propofol; Drug: Sevoflurane Overall survival; The presence of disease progression; Postoperative complications; Karnofsky performance status score; Length of hospital stays Kaohsiung Medical University Chung-Ho Memorial Hospital; Tri-Service General Hospital All 20 Years to 80 Years (Adult, Older Adult) 500 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment KMUHIRB-F(I)-20220034 26/04/2022 31/12/2026 31/03/2027 18/04/2022 30/11/2022 https://ClinicalTrials.gov/show/NCT05331911 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan GI Liver Cancer Propofol PFS; OS; Other (specify) Phase 4 DB00571 N
NCT05679193 Perioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence PeP-RALP Recruiting Prostate Cancer Drug: Propranolol The feasibility of conducting a formal larger RCT to compare the efficacy of propranolol vs placebo to decrease PCa recurrence following RALP.; Safety and tolerability of PeP-RALP intervention; Determine the effect of RALP on catecholamine levels; Determine the bioavailability of propranolol; Determine the effect of preoperative propranolol treatment on the serum level of PSA; To determine the effect of propranolol on post-operative biochemical failure; Intraoperative anesthesiological and surgical challenges Surgical complications in PeP RALP patients; Surgical complications Oslo University Hospital Male 40 Years to 80 Years (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment 488466 01/02/2023 10/01/2023 10/01/2023 01/10/2023 02/09/2023 https://ClinicalTrials.gov/show/NCT05679193 Localised/Locoregional Hospital/University/Research Institute Y N N Norway Urological Prostate Cancer Propranolol Other (specify) Phase 2 DB00165 N
NCT04493489 Propranolol Adjuvant Treatment of Bladder Cancer Not yet recruiting Bladder Cancer Drug: Propranolol Hydrochloride; Drug: BCG two-year recurrence-free survival Central South University All 18 Years to 75 Years (Adult, Older Adult) 242 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 2020/prop/bladder/CSU 09/06/2020 09/06/2023 09/06/2024 30/07/2020 30/07/2020 https://ClinicalTrials.gov/show/NCT04493489 Localised/Locoregional Hospital/University/Research Institute Y N N China Urological Bladder Cancer Propranolol DFS/RFS/EFS Phase 2 DB00165 N
NCT05979818 Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer BRIO Not yet recruiting Non Small Cell Lung Cancer|Propranolol Drug: Propranolol hydrochloride; Drug: Sintilimab; Drug: Chemotherapy Objective Response Rate (ORR); Disease Control Rate (DCR); Adverse events (AEs); Progression-free survival (PFS); Overall survival (OS); Quality of life (QoL) Second Xiangya Hospital of Central South University; Innovent Biologics (Suzhou) Co. Ltd. All 18 Years to 75 Years (Adult, Older Adult) 6 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment XYEYY20230705 31/12/2023 31/08/2025 31/12/2026 08/07/2023 21/11/2023 https://ClinicalTrials.gov/show/NCT05979818 Advanced/Metastatic Hospital/University/Research Institute N N N China Lung Non-Small Cell Lung Cancer Propranolol Safety and/or Dose; Response rate; PFS; OS; QoL Phase 1 DB00165 N
NCT05741164 Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer Not yet recruiting Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Triple-Negative Breast Carcinoma|Refractory Triple-Negative Breast Carcinoma|Unresectable Triple-Negative Breast Carcinoma Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Pembrolizumab; Drug: Propranolol; Other: Questionnaire Administration Objective response; Progression free survival; Overall survival; Incidence of adverse events of propranolol when given in combination with pembrolizumab Roswell Park Cancer Institute All 18 Years and older (Adult, Older Adult) 25 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 2612022; NCI-2023-00641 15/02/2024 15/12/2026 15/12/2027 23/02/2023 01/05/2024 https://ClinicalTrials.gov/show/NCT05741164 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Propranolol Response rate Phase 2 DB00165 N
NCT02897986 Study of a Propranolol (HEMANGIOL ) and Oral Metronomic Vinorelbine (NAVELBINE ) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors PROVIN Unknown status Pediatric Cancer Drug: administration of a propranolol (HEMANGIOL ) and oral metronomic vinorelbine (NAVELBINE ) combination number of patients with grade 3 toxicity Assistance Publique Hopitaux De Marseille All 4 Years to 21 Years (Child, Adult) 54 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2016-06 01/01/2017 01/01/2020 01/01/2021 13/09/2016 13/09/2016 https://ClinicalTrials.gov/show/NCT02897986 Recurrent/Refractory Hospital/University/Research Institute N N Y France Multiple cancer types Any solid tumours Propranolol Safety and/or Dose Phase 1 DB00165 N
NCT05451043 Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) Not yet recruiting Pancreatic Cancer|Hepatocellular Cancer|Biliary Tract Cancer|Cholangiocarcinoma Biological: Durvalumab; Drug: Gemcitabine; Drug: Nab paclitaxel; Biological: Tremelimumab; Drug: Propranolol; Drug: Cisplatin Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in pancreatic adenocarcinoma; Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in hepatocellular carcinoma; Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in biliary tract tumors; Feasibility of study therapy; Safety/tolerability; Progression-free survival; Overall Survival AHS Cancer Control Alberta All 18 Years and older (Adult, Older Adult) 62 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IIT-0027 03/01/2023 10/01/2025 10/01/2028 07/11/2022 02/02/2023 https://ClinicalTrials.gov/show/NCT05451043 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Cholangiocaricnoma; Pancreatic Cancer; Liver Cancer Propranolol Other (specify) Phase 2 DB00165 N
NCT04848519 Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma Recruiting Locally Advanced Bladder Urothelial Carcinoma|Locally Advanced Renal Pelvis Urothelial Carcinoma|Locally Advanced Ureter Urothelial Carcinoma|Locally Advanced Urethral Urothelial Carcinoma|Locally Advanced Urothelial Carcinoma|Metastatic Bladder Urothelial Carcinoma|Metastatic Renal Pelvis Urothelial Carcinoma|Metastatic Ureter Urothelial Carcinoma|Metastatic Urethral Urothelial Carcinoma|Metastatic Urothelial Carcinoma|Stage IV Bladder Cancer AJCC v8|Stage IV Renal Pelvis Cancer AJCC v8|Stage IV Ureter Cancer AJCC v8|Stage IV Urethral Cancer AJCC v8 Drug: Pembrolizumab; Drug: Propranolol Hydrochloride; Drug: Nivolumab; Drug: Avelumab Incidence of adverse events; Progression free survival (PFS); Overall survival (OS); Objective Response Rate (ORR) Emory University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 24 Other; NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00002186; NCI-2021-00437; WINSHIP5200-20; P30CA138292 20/05/2021 01/01/2024 01/01/2025 19/04/2021 27/07/2023 https://ClinicalTrials.gov/show/NCT04848519 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Bladder Cancer Propranolol Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00165 N
NCT03384836 Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery Recruiting Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7 Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab; Drug: Propranolol Hydrochloride Dose limiting toxicities (DLT) defined as any grade 3 or higher hematological or non-hematological toxicity that is probably or definitely related to treatment according to Common Terminology Criteria for Adverse Events version 4.03 (Phase Ib); Overall response rate (ORR) per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) version 1.1 (Phase II); Overall survival (OS) (Phase II); PFS (Phase II); Progression free survival (PFS) (Phase II) Roswell Park Cancer Institute All 18 Years and older (Adult, Older Adult) 47 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 53217; NCI-2017-02210 31/01/2018 31/01/2025 31/01/2025 27/12/2017 11/09/2023 https://ClinicalTrials.gov/show/NCT03384836 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Propranolol Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00165 N
NCT04682158 Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma Recruiting Esophageal Adenocarcinoma Drug: Carboplatin; Radiation: 3 Dimensional Conformal Radiation Therapy; Drug: Propranolol; Radiation: Intensity Modulated Radiation Therapy; Drug: Paclitaxel Occurrence of Adverse Events; Progression Free Survival; Overall Survival Roswell Park Cancer Institute All 18 Years and older (Adult, Older Adult) 106 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment I 630420 04/01/2021 04/01/2027 04/01/2027 23/12/2020 22/11/2023 https://ClinicalTrials.gov/show/NCT04682158 Localised/Locoregional Hospital/University/Research Institute Y Y N United States GI Esophageal Cancer Propranolol Safety and/or Dose; PFS; OS Phase 2 DB00165 N
NCT05651594 Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma Recruiting Clinical Stage II Esophageal Adenocarcinoma AJCC v8|Clinical Stage III Esophageal Adenocarcinoma AJCC v8|Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8|Clinical Stage IV Esophageal Adenocarcinoma AJCC v8|Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8|Locally Advanced Esophageal Adenocarcinoma|Locally Advanced Gastroesophageal Junction Adenocarcinoma|Metastatic Esophageal Adenocarcinoma|Metastatic Gastroesophageal Junction Adenocarcinoma|Unresectable Esophageal Adenocarcinoma|Unresectable Gastroesophageal Junction Adenocarcinoma Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Biological: Pembrolizumab; Drug: Propranolol Hydrochloride; Other: Questionnaire Administration Overall response rate (ORR); Incidence of toxicities and adverse events; Progression-free survival; Overall survival; ORR Roswell Park Cancer Institute; United States Department of Defense All 18 Years and older (Adult, Older Adult) 40 Other; U.S. Fed Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 2734222; NCI-2022-09209; W81XWH2210916 03/07/2023 30/03/2026 30/03/2026 15/12/2022 22/12/2023 https://ClinicalTrials.gov/show/NCT05651594 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Esophageal Cancer Propranolol Response rate Phase 2 DB00165 N
NCT03108300 Use of Propranolol Hydrochloride in the Treatment of Metastatic STS Unknown status Malignant Soft Tissue Sarcoma Drug: Propranolol Hydrochloride; Drug: Doxorubicin Progression Free Survival; Overall Survival Ain Shams University All 19 Years and older (Adult, Older Adult) 50 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CURE002 30/08/2019 30/08/2020 30/08/2021 04/11/2017 23/02/2018 https://ClinicalTrials.gov/show/NCT03108300 Advanced/Metastatic Hospital/University/Research Institute N N N Egypt Soft Tissue Sarcoma Any soft tissue sarcoma Propranolol PFS; OS Phase 2 DB00165 N
NCT05797662 A Study of Propranolol to Treat Kaposi Sarcoma Not yet recruiting Kaposi Sarcoma Drug: Propranolol Objective Response Rate; Number of dose-limiting toxicities; Number of treatment-emergent adverse events; Complete and Partial Response rates in children and adults; Time to recurrence among children; Time to recurrence among adults; Time to progression among children; Time to progression among adults AIDS Malignancy Consortium; National Cancer Institute (NCI) All Child, Adult, Older Adult 25 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AMC-116; UM1CA121947 07/01/2024 08/01/2026 08/01/2028 04/04/2023 18/04/2023 https://ClinicalTrials.gov/show/NCT05797662 Localised/Locoregional Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma Kaposi Sarcoma (non-AIDS related) Propranolol Response rate Phase 2 DB00165 N
NCT05961761 Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients PROPANE Recruiting Soft Tissue Sarcoma Adult|Angiosarcoma|Undifferentiated Pleomorphic Sarcoma Drug: Propranolol; Drug: Pembrolizumab Progression-free survival rate; Objective response rate; Duration of Response; Progression Free Survival; Overall Survival; Safety of the treatment; Quality of Life assessment Niels Junker; Aarhus University Hospital; Oslo University Hospital; Karolinska University Hospital; Herlev and Gentofte Hospital All 18 Years and older (Adult, Older Adult) 80 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SA2115 17/08/2021 01/01/2028 12/01/2028 27/07/2023 27/07/2023 https://ClinicalTrials.gov/show/NCT05961761 Advanced/Metastatic Hospital/University/Research Institute N N N Denmark Soft Tissue Sarcoma Angiosarcoma; Other Soft Tissue Sarcoma Propranolol Safety and/or Dose; Response rate; PFS; OS; QoL Phase 2 DB00165 N
NCT02962947 MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients Unknown status Melanoma Drug: Propranolol; Drug: Placebo Effect of Propranolol on overall survival for melanoma patients in stage II/IIIA (T2, N0 or N1, M0); Effect of Propranolol on disease free survival for melanoma patients in stage II/IIIA; Effect of propranolol on specific mortality for melanoma patients in stage II/IIIA; Effect of propranolol treatment on the long-term safety on melanoma patients in stage II/IIIA Azienda Sanitaria di Firenze All 18 Years to 75 Years (Adult, Older Adult) 546 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment EudraCT 2014---003970---18 06/01/2017 06/01/2019 06/01/2022 15/11/2016 15/11/2016 https://ClinicalTrials.gov/show/NCT02962947 Localised/Locoregional Hospital/University/Research Institute N N N Italy Skin Melanoma Propranolol OS; DFS/RFS/EFS Phase 2/3 DB00165 N
NCT03392246 A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor na ve Advanced EGFR Mutant Lung Cancer Active, not recruiting Non-small Cell Lung Cancer Drug: Osimertinib; Drug: Selumetinib Best Objective Response; Progression Free Survival; Overall Survival; Tolerability Proportion; Toxicity Grading Dana-Farber Cancer Institute; National Comprehensive Cancer Network All 18 Years and older (Adult, Older Adult) 25 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 17-540 31/01/2018 30/06/2024 30/06/2026 01/05/2018 01/10/2024 https://ClinicalTrials.gov/show/NCT03392246 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose; Response rate; PFS; OS Phase 2 DB01104 N
NCT00463814 AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Patients With Advanced Solid Malignancies Active, not recruiting Tumor|Cancer Drug: AZD6244 To assess the pharmacokinetics of the solid dose form of AZD6244; To assess safety and tolerability of solid dose form of AZD6244 AstraZeneca All 18 Years to 99 Years (Adult, Older Adult) 58 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment D1532C00005; 2006-004497-26 03/08/2007 17/06/2008 29/12/2023 20/04/2007 17/10/2023 https://ClinicalTrials.gov/show/NCT00463814 Advanced/Metastatic Company N N N United Kingdom Multiple cancer types Any solid tumours Selumetinib Safety and/or Dose Phase 1 DB01104 N
NCT01933932 Assess Efficacy Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC SELECT-1 Active, not recruiting Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV Drug: Selumetinib; Drug: Docetaxel; Drug: Placebo; Drug: Pegylated G-CSF Progression-Free Survival (PFS); Overall Survival (OS); Objective Response Rate (ORR); Duration of Response (DoR); Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS); Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS) AstraZeneca All 18 Years to 130 Years (Adult, Older Adult) 510 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment D1532C00079; 2013-001676-38 25/09/2013 06/07/2016 29/12/2023 09/02/2013 29/08/2017 17/10/2023 https://ClinicalTrials.gov/show/NCT01933932 Palliative Advanced/Metastatic; Recurrent/Refractory Company Y N N United Kingdom Lung Non-Small Cell Lung Cancer Selumetinib Response rate; PFS; OS Phase 3 DB01104 N
NCT02450656 Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer M14AFS Unknown status Colorectal Neoplasms|Gastrointestinal Neoplasms|Pancreatic Neoplasms|Carcinoma, Non-Small-Cell Lung Drug: Afatinib; Drug: Selumetinib; Drug: Docetaxel Dose Limiting Toxicities (Phase I); Progression Free Survival (Phase II); Tolerability (Incidence and severity of adverse events per CTCAE v4.03); Plasma concentrations of afatanib and selumetinib; Efficacy (Phase II) (Overall response rate (ORR), duration of response (DOR) , time to response (TTR) and overall survival (OS) per RECIST v1.1) The Netherlands Cancer Institute; AstraZeneca; Boehringer Ingelheim All 18 Years and older (Adult, Older Adult) 320 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment M14AFS 06/01/2015 05/01/2019 12/01/2019 21/05/2015 27/08/2018 https://ClinicalTrials.gov/show/NCT02450656 Advanced/Metastatic Hospital/University/Research Institute Y N N Netherlands Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose; Response rate; PFS Phase 1/2 DB01104 N
NCT03801369 Olaparib in Combination With Either Durvalumab, Selumetinib, or Capivasertib or Ceralasertib Alone in Treating Patients With Metastatic Triple Negative Breast Cancer Recruiting Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Triple-Negative Breast Carcinoma Procedure: Biopsy; Drug: Capivasertib; Drug: Ceralasertib; Biological: Durvalumab; Drug: Olaparib; Other: Quality-of-Life Assessment; Drug: Selumetinib Objective response rate (ORR); Clinical benefit rate (CBR); Duration of response (DOR); Progression-free survival (PFS); Overall survival (OS); Incidence of grade 3+ acute toxicity OHSU Knight Cancer Institute; AstraZeneca; Oregon Health and Science University All 18 Years and older (Adult, Older Adult) 132 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00018504; NCI-2019-00388 12/12/2018 31/12/2024 31/12/2027 01/11/2019 21/08/2023 https://ClinicalTrials.gov/show/NCT03801369 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Breast Breast Cancer - TNBC Selumetinib Response rate Phase 2 DB01104 N
NCT03162627 Selumetinib and Olaparib in Solid Tumors Active, not recruiting Malignant Neoplasm of Breast|Malignant Neoplasms of Digestive Organs|Malignant Neoplasms of Female Genital Organs|Malignant Neoplasms of Male Genital Organs|Malignant Neoplasms of Thyroid and Other Endocrine Glands Drug: Selumetinib; Drug: Olaparib Maximum Tolerated Dose (MTD) for Combination of Selumetinib and Olaparib in Participants with Advanced or Recurrent Solid Tumors; Determination of Drug Concentration in Selumetinib and Olaparib; Comparison of Baseline Expression Values with Differing Treatment Responses of Selumetinib and Olaparib; Anti-Tumor Activity Evaluation by RECIST v1.1 M.D. Anderson Cancer Center; AstraZeneca All 18 Years and older (Adult, Older Adult) 90 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2016-1129; NCI-2018-01205 08/04/2017 30/08/2026 30/08/2026 22/05/2017 10/04/2023 https://ClinicalTrials.gov/show/NCT03162627 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Multiple cancer types Any solid tumours Selumetinib Safety and/or Dose Phase 1 DB01104 N
NCT03581487 Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer Recruiting Recurrent Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8 Biological: Durvalumab; Drug: Selumetinib; Biological: Tremelimumab Maximum tolerated dose (MTD) (dose-escalation phase); Progression free survival time (PFS) (dose expansion phase); Response rate by Response Evaluation Criteria in Solid Tumors 1.1; Disease control rate (complete response + partial response + stable disease); Overall survival (OS); Incidence of adverse events M.D. Anderson Cancer Center; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 40 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2017-0888; NCI-2018-01098 04/01/2019 31/12/2024 31/12/2024 07/10/2018 18/11/2023 https://ClinicalTrials.gov/show/NCT03581487 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Lung Non-Small Cell Lung Cancer Selumetinib Response rate; PFS; OS Phase 1/2 DB01104 N
NCT01364051 Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies Active, not recruiting Metastatic Melanoma|Refractory Malignant Solid Neoplasm|Stage IV Cutaneous Melanoma AJCC v6 and v7|Unresectable Malignant Solid Neoplasm Drug: Cediranib; Drug: Cediranib Maleate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Selumetinib; Drug: Selumetinib Sulfate Maximum tolerated dose (MTD); Incidence of adverse events, classified as either possibly, probably, or definitely related to study treatment; Incidence of hematologic toxicities; Incidence of non-hematologic toxicities; Overall toxicity incidence; Best response National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 19 NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2012-02906; CDR0000700596; MC1012; NCI-2011-01083; 8810; P30CA015083; U01CA069912; UM1CA186686 25/05/2011 06/06/2019 06/02/2011 11/08/2023 https://ClinicalTrials.gov/show/NCT01364051 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Skin; Multiple cancer types Melanoma; Any solid tumours Selumetinib Safety and/or Dose; Response rate Phase 1 DB01104 N
NCT02393690 Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer Active, not recruiting Metastatic Thyroid Gland Carcinoma|Poorly Differentiated Thyroid Gland Carcinoma|Recurrent Thyroid Gland Carcinoma|Stage IV Thyroid Gland Follicular Carcinoma AJCC v7|Stage IV Thyroid Gland Papillary Carcinoma AJCC v7|Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7|Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7|Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7|Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7|Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7|Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Radiation: Iodine I-131; Other: Placebo Administration; Drug: Selumetinib Response at 6 Months; Best Overall Response; Progression Free Survival (PFS); Changes in Serum Thyroglobulin Levels; Incidence of Adverse Events Academic and Community Cancer Research United; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 60 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment RU241306I; NCI-2015-00277; 14-008494; P30CA015083 05/04/2015 17/07/2020 31/12/2023 19/03/2015 08/03/2021 02/02/2023 https://ClinicalTrials.gov/show/NCT02393690 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N United States Endocrine Thyroid Cancer Selumetinib Safety and/or Dose; Response rate; PFS; Biomarker Phase 2 DB01104 N
NCT03213691 Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Active, not recruiting Advanced Malignant Solid Neoplasm|Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma|Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma|Recurrent Childhood Central Nervous System Neoplasm|Recurrent Childhood Non-Hodgkin Lymphoma|Recurrent Malignant Solid Neoplasm|Recurrent Neuroblastoma|Refractory Malignant Solid Neoplasm|Refractory Neuroblastoma|Refractory Non-Hodgkin Lymphoma|Refractory Primary Central Nervous System Neoplasm Other: Laboratory Biomarker Analysis; Drug: Selumetinib; Drug: Selumetinib Sulfate Response Rate; Percentage of Participants With Treatment-related Adverse Events as Accessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0; Progression Free Survival (PFS) National Cancer Institute (NCI) All 12 Months to 21 Years (Child, Adult) 21 NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2017-01250; APEC1621E; U10CA180886 30/10/2017 30/06/2021 22/09/2024 07/11/2017 13/12/2022 12/04/2023 https://ClinicalTrials.gov/show/NCT03213691 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Lymphoma; Multiple cancer types Non-Hodgkin Lymphoma, Childhood; Non-Hodgkin Lymphoma, Adult; Any solid tumours Selumetinib Safety and/or Dose; Response rate; PFS Phase 2 DB01104 N
NCT05554328 Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial Recruiting Recurrent Endometrial Carcinoma|Recurrent Fallopian Tube Carcinoma|Recurrent Ovarian Carcinoma|Recurrent Primary Peritoneal Carcinoma Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Computed Tomography; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Drug: Olaparib; Drug: Selumetinib Sulfate Progression-free survival (PFS); Incidence of adverse events (AE); Objective response rate (ORR) between two arms; ORR in crossover patients; Duration of response of both arms National Cancer Institute (NCI); NRG Oncology Female 18 Years and older (Adult, Older Adult) 165 NIH; Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2022-06841; EAY191-N4; U10CA180868 25/04/2023 30/09/2024 30/09/2024 26/09/2022 01/02/2024 https://ClinicalTrials.gov/show/NCT05554328 Recurrent/Refractory Collaborative Group N Y N United States Gynaecological Endometrial Cancer; Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer Selumetinib PFS Phase 2 DB01104 N
NCT02151084 A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer Active, not recruiting Biliary Tract Carcinoma|Gallbladder Carcinoma Drug: Selumetinib; Drug: Cisplatin; Drug: Gemcitabine Change in tumor size in millimetres; Number of participants with objective response and/or stable disease; Percentage of patients without progressive disease; Progression-free survival in months; Overall survival in months; Total incidence of adverse events; Total rate of grade 3 and 4 toxicities University Health Network, Toronto All 18 Years and older (Adult, Older Adult) 57 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BIL-MEK 11/01/2014 12/01/2023 02/01/2024 30/05/2014 18/06/2023 https://ClinicalTrials.gov/show/NCT02151084 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N Canada Urological; GI Bladder Cancer; Cholangiocaricnoma Selumetinib Safety and/or Dose; Response rate; PFS; OS Phase 2 DB01104 N
NCT03326310 Selumetinib and Azacitidine in High Risk Chronic Blood Cancers Recruiting Chronic Myeloid Leukemia|Myelofibroses Drug: Azacitidine; Drug: Selumetinib Number of patients with adverse events; Time to completion of next generation sequencing panel.; Rate of overall response.; Rate of symptom response.; Rate of overall survival.; Rate of progression free survival. University of Chicago All 18 Years and older (Adult, Older Adult) 18 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB17-0774 09/04/2018 09/04/2023 09/04/2025 31/10/2017 29/08/2023 https://ClinicalTrials.gov/show/NCT03326310 Other (specify) Hospital/University/Research Institute N N N United States Leukemia; Other Haem-onc Chronic Myelogenous Leukemia; Myelodysplastic Syndromes Selumetinib Safety and/or Dose; Response rate; PFS; OS Phase 1 DB01104 N
NCT02143466 AZD9291 in Combination With Ascending Doses of Novel Therapeutics Active, not recruiting Advanced Non Small Cell Lung Cancer Drug: Part A - AZD9291 in combination with AZD6094; Drug: Part A - AZD9291 in combination with continuous selumetinib (Asian subjects); Drug: Part A - AZD9291 in combination with continuous selumetinib (non-Asian subjects); Drug: Part A - AZD9291 in combination with intermittent selumetinib; Drug: Part A - AZD9291 in combination with MEDI4736; Drug: Part B - AZD9291 in combination with AZD6094; Drug: Part B - AZD9291 in combination with selumetinib; Drug: Part B - AZD9291 in combination with MEDI4736; Drug: Part C - AZD6094 monotherapy (Japan only); Drug: Part C - AZD9291 in combination with AZD6094 (Japan only); Drug: Part D - AZD9291 in combination with AZD6094 Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib; Number of participants with Adverse Events as a measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib; Cmax after single dosing; Tmax after single dosing; AUC after single dosing; AUC0-t after single dosing; AUC0-24 after single dosing; Terminal half life after single dosing; CL/f after single dosing; Volume of distribution after single dosing; Cssmax after multiple dosing; Tssmax after multiple dosing; Cssmin after multiple dosing; AUCss after multiple dosing; CLss/f after multiple dosing; Rac after multiple dosing; Time dependency of PK after multiple dosing; Objective response rate; Disease control rate; Duration of response; Percentage change in tumour size; Progression free survival; Overall survival AstraZeneca All 18 Years to 130 Years (Adult, Older Adult) 344 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment D5160C00006; 2016-004752-29 08/05/2014 03/04/2020 29/12/2023 21/05/2014 12/05/2023 https://ClinicalTrials.gov/show/NCT02143466 Advanced/Metastatic; Recurrent/Refractory Company N Y N United States Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose Phase 1 DB01104 N
NCT03944772 Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) ORCHARD Active, not recruiting Non-Small Cell Lung Cancer Drug: Osimertinib; Drug: Savolitinib; Drug: Gefitinib; Drug: Necitumumab; Drug: Durvalumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Alectinib; Drug: Selpercatinib; Drug: Selumetinib; Drug: Etoposide; Drug: Cisplatin; Drug: Datopotamab deruxtecan Objective response rate (ORR); Progression-free survival (PFS); Duration of response (DoR); Overall survival (OS); Plasma concentrations of therapeutic agents; Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5 AstraZeneca All 18 Years to 130 Years (Adult, Older Adult) 250 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment D6186C00001; 2018-003974-29 25/06/2019 28/11/2025 28/11/2025 05/10/2019 01/08/2024 https://ClinicalTrials.gov/show/NCT03944772 Recurrent/Refractory Company Y Y N United States Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose; Response rate; PFS; OS; Biomarker Phase 2 DB01104 N
NCT05253131 Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas Not yet recruiting MPNST|NF1|Sarcoma Drug: Selumetinib Safety and Tolerability Selumetinib with BI; Safety and Tolerability of Durvalumab with Selumetinib and BI; Determine the Clinical Benefit of Selumetinib, BI and Durvalumab University of Alabama at Birmingham; United States Department of Defense All 18 Years to 99 Years (Adult, Older Adult) 41 Other; U.S. Fed Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 300006373 15/06/2024 15/06/2029 15/06/2030 23/02/2022 01/09/2024 https://ClinicalTrials.gov/show/NCT05253131 Any/All Stages Hospital/University/Research Institute N N N United States Bone Sarcoma; Soft Tissue Sarcoma Osteosarcoma; Ewing Sarcoma; Rhabdomyosarcoma Selumetinib Safety and/or Dose; Other (specify) Phase 1/2 DB01104 N
NCT02546661 Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer BISCAY Active, not recruiting Muscle Invasive Bladder Cancer Drug: AZD4547; Drug: MEDI4736; Drug: Olaparib; Drug: AZD1775; Drug: Vistusertib; Drug: AZD9150; Drug: Selumetinib Module A: The frequency and nature of adverse events related to AZD4547 monotherapy.; Module A: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral AZD4547.; Module B: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral olaparib.; Module C: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral AZD1775.; Module D: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) monotherapy.; Module E: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral vistusertib.; Module F: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and intravenous AZD9150.; Module G: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral selumetinib.; All Modules: Change from baseline in clinical chemistry parameters.; All Modules: Change from baseline in haematology parameters.; All Modules: Change from baseline in urinalysis results.; All Modules: Change from baseline in vital signs.; All Modules: Change from baseline in physical examination findings.; All Modules: Change from baseline in ECG findings.; All Modules: Change from baseline in ejection fraction determined by assessing ECHO/MUGA scans.; All Modules: Change from baseline in coagulation parameters; All Modules: Change from baseline in lipid profile; Objective response rate (ORR); Disease control rate (DCR); Progression free survival (PFS); Duration of response (DoR); Overall survival (OS) rate at 1 year; Plasma concentration of AZD4547 (Module A); Plasma concentration of MEDI4736 (durvalumab) (Module A); Plasma concentration of olaparib (Module B); Plasma concentration of AZD1775 (Module C); Plasma concentration of MEDI4736 (durvalumab) (Module C); Plasma concentration of MEDI4736 (durvalumab) (Module D); Plasma concentration of vistusertib (Module E); Plasma concentration of Medi4736 (durvalumab) (Module E).; Plasma concentration of AZD9150 (Module F); Plasma concentration of MEDI4736 (durvalumab) (Module F).; The presence of Anti-Drug Antibodies (ADA) and ADA neutralising antibodies to MEDI4736 will be assessed in patients receiving MEDI4736 in any sub-study module. AstraZeneca All 18 Years to 130 Years (Adult, Older Adult) 156 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment D2615C00001; GU 118; BISCAY; 2015-002228-25 10/03/2016 18/03/2020 28/06/2024 09/11/2015 12/11/2023 https://ClinicalTrials.gov/show/NCT02546661 Advanced/Metastatic Company N Y N United States Urological Bladder Cancer Selumetinib Safety and/or Dose Phase 1 DB01104 N
NCT01306045 Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies Active, not recruiting Carcinoma, Non-Small-Cell Lung|Carcinoma, Small Cell Lung|Carcinoma, Thymic Drug: AZD6244; Drug: MK-2206; Drug: Lapatinib; Drug: Erlotinib; Drug: Sunitinib; Procedure: Molecular Profiling Percentage of Enrolled Participants Testing Positive for Genomic Abnormality; Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies; Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile; Frequency of Epidermal Growth Factor Receptor (EGFR) Germline Mutations in Families With High Susceptibility to Lung Cancer National Cancer Institute (NCI); National Institutes of Health Clinical Center (CC) All 18 Years and older (Adult, Older Adult) 647 NIH Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 110096; 11-C-0096 02/08/2011 02/12/2014 31/12/2024 03/01/2011 04/11/2023 04/11/2023 https://ClinicalTrials.gov/show/NCT01306045 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Lung; Endocrine Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Thymoma and Thymic Carcinoma Selumetinib Response rate; Other (specify) Phase 2 DB01104 N
NCT02299999 SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer SAFIR02_Breast Active, not recruiting Metastatic Breast Cancer Drug: AZD2014; Drug: AZD4547; Drug: AZD5363; Drug: AZD8931; Drug: Selumetinib; Drug: Vandetanib; Drug: Bicalutamide; Drug: Olaparib; Drug: Anthracyclines; Drug: Taxanes; Drug: cyclophosphamide; Drug: DNA intercalators; Drug: Methotrexate; Drug: vinca alkaloids; Drug: Platinum based chemotherapies; Drug: Bevacizumab; Drug: Mitomycin C; Drug: Eribulin; Drug: MEDI4736 Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm; progression-free survival in patients treated with anti-PDL1 antibody (MEDI4736) compared to standard maintenance therapy arm; overall survival in each substudy; overall response rates and changes in tumor size in each substudy; evaluate safety, in each substudy; efficacy (response rate, change in tumor size, progression-free survival, overall survival) and safety of each individual targeted agent (substudy 1); correlate molecular characteristics in patients with the efficacy endpoints (response rate, progression-free and overall survival) in each substudy UNICANCER; Fondation ARC; AstraZeneca All 18 Years and older (Adult, Older Adult) 1460 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UC-0105/1304; 2013-001652-36 04/07/2014 12/01/2022 12/01/2024 24/11/2014 01/10/2024 https://ClinicalTrials.gov/show/NCT02299999 Advanced/Metastatic Hospital/University/Research Institute Y Y N France Breast Any Breast Cancer Selumetinib Response rate; PFS; OS Phase 2 DB01104 N
NCT04348045 Personalized Maintenance Therapy for m-PDAC Using Olaparib or Selumetinib + Durvalumab, Based on BRCAness and KRAS Status. MAZEPPA Active, not recruiting Metastatic Pancreatic Adenocarcinoma Drug: Arm A - Olaparib; Drug: ARM B - durvalumab plus selumetinib; Drug: ARM C FOLFIRI ARM A - Progression free survival (PFS); ARM B/ C - PFS; Disease control rate (DCR); Overall response rate (ORR); Overall survival (OS); Number of participants with treatment-related adverse events; Time to HRQoL score definitive deterioration (TUDD) GERCOR - Multidisciplinary Oncology Cooperative Group; AstraZeneca All 18 Years and older (Adult, Older Adult) 307 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MAZEPPA D19-02 PRODIGE-72 12/07/2020 07/12/2023 12/01/2024 15/04/2020 01/05/2024 https://ClinicalTrials.gov/show/NCT04348045 Advanced/Metastatic Collaborative Group Y Y N France GI Pancreatic Cancer Selumetinib Safety and/or Dose; Response rate; PFS; OS Phase 2 DB01104 N
NCT01089101 Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma Active, not recruiting Low Grade Glioma|Recurrent Childhood Pilocytic Astrocytoma|Recurrent Neurofibromatosis Type 1|Recurrent Visual Pathway Glioma|Refractory Neurofibromatosis Type 1|Refractory Visual Pathway Glioma Procedure: Biospecimen Collection; Drug: Selumetinib Maximum tolerated dose and recommended phase 2 dose of selumetinib determined by dose-limiting toxicities (phase I); Stratum-specific objective response (complete response + partial response) rate sustained for 8 weeks (phase II); Objective response (objective response = complete response + partial response) (re-treatment study); Disease stabilization rates (re-treatment study); Plasma drug concentrations and pharmacokinetic parameters (Phase I); Stratum-specific progression-free survival distribution (PFS) (phase II); Presence or absence of BRAF V600E mutations or BRAF KIAA1549 fusion (phase II); Progression-free survival (retreatment study) National Cancer Institute (NCI) All 3 Years to 21 Years (Child, Adult) 220 NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2012-03173; PBTC-029B; CDR667932; PBTC-029; U01CA081457; UM1CA081457 19/04/2010 12/01/2025 12/01/2025 18/03/2010 11/08/2023 https://ClinicalTrials.gov/show/NCT01089101 Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS Glioma Selumetinib Safety and/or Dose; Response rate; Biomarker Phase 1/2 DB01104 N
NCT04576117 A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma Suspended Recurrent Low Grade Astrocytoma|Recurrent WHO Grade 2 Glioma|Refractory Low Grade Astrocytoma|Refractory Low Grade Glioma|Refractory WHO Grade 1 Glioma Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Selumetinib Sulfate; Drug: Vinblastine Sulfate Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of selumetinib and vinblastine combination (feasibility); Event-free survival (efficacy); Radiographic tumor response rate (efficacy); Overall survival (OS) (efficacy); EFS by BRAF Status; Incidence of adverse events (feasibility); Incidence of adverse events (efficacy); Quality of life (QOL); Visual outcome comparison National Cancer Institute (NCI) All 2 Years to 25 Years (Child, Adult) 300 NIH Interventional Study Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2020-07549; ACNS1931; U10CA180886 16/02/2021 30/12/2026 30/12/2026 10/06/2020 18/12/2023 https://ClinicalTrials.gov/show/NCT04576117 Palliative Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioma Selumetinib Safety and/or Dose; OS; DFS/RFS/EFS Phase 3 DB01104 N
NCT04166409 A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma Recruiting Low Grade Astrocytoma|Low Grade Glioma|Metastatic Low Grade Astrocytoma|Metastatic Low Grade Glioma Procedure: Biospecimen Collection; Drug: Carboplatin; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Selumetinib Sulfate; Drug: Vincristine Sulfate Event-free survival (EFS); Radiographic tumor response rate; Overall survival (OS); Number of patients who experience an improvement in visual acuity (VA); Change in motor function; Change in quality of life (QOL); Processing speed function; Change in executive function National Cancer Institute (NCI) All 2 Years to 21 Years (Child, Adult) 220 NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2019-07600; ACNS1833; U10CA180886 31/01/2020 31/12/2026 31/12/2026 18/11/2019 01/10/2024 https://ClinicalTrials.gov/show/NCT04166409 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N United States CNS Glioma Selumetinib Response rate; OS; DFS/RFS/EFS; QoL Phase 3 DB01104 N
NCT01817751 Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma Active, not recruiting Glioblastoma|Recurrent Adult Brain Neoplasm|Malignant Glioma|WHO Grade III Glioma Drug: sorafenib tosylate; Drug: valproic acid; Drug: sildenafil citrate Number of Participants With 6-Month Progression Free Survival (PFS); Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.; Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.; Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.; Number of Participants With 12-Month Progression Free Survival (PFS).; Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month PFS.; Evaluation of Safety and Toxicity of Sorafenib, Valproic Acid, and Sildenafil Virginia Commonwealth University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 47 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MCC-14816; HM14816; NCI-2013-00705; P30CA016059 04/11/2013 27/08/2020 30/10/2027 25/03/2013 28/10/2021 04/06/2023 https://ClinicalTrials.gov/show/NCT01817751 Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioblastoma Sildenafil; Valproic Acid Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00641; DB00177 N
NCT05586360 T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer Recruiting Prostate Cancer Drug: Simvastatin 40mg Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area; Intra-prostatic YAP-mediated T-reg dysfunction, limited to tumor infiltrating Tregs; Intra-prostatic YAP-mediated T-reg dysfunction, limited to T-regs in adjacent normal and stromal tissue; Intra-prostatic anti-tumor immune response Medical University of South Carolina Male 18 Years and older (Adult, Older Adult) 36 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 103472 30/03/2024 02/01/2025 08/01/2025 19/10/2022 12/01/2023 https://ClinicalTrials.gov/show/NCT05586360 Localised/Locoregional Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Simvastatin Other (specify) Phase 2 DB00877 N
NCT04457089 Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer Recruiting Recurrent Ovarian Cancer|Platinum-sensitive Ovarian Cancer Drug: Simvastatin 40mg Completion of the simvastatin intervention with at least 85 compliance; Response by CA125; Progression-free survival Bobbie Jo Rimel, MD; Cedars-Sinai Medical Center Female 18 Years and older (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IIT2020-03-Rimel-STOV 25/01/2021 01/01/2024 01/01/2025 07/07/2020 10/04/2023 https://ClinicalTrials.gov/show/NCT04457089 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Ovarian - Other Simvastatin PFS; Biomarker; Other (specify) Phase 1 DB00877 N
NCT05550415 The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer Recruiting Triple Negative Breast Cancer|Chemotherapy Effect|Simvastatin Adverse Reaction Drug: Simvastatin 40mg; Drug: Placebo Vimentin Expression; Pathological Response; Clinical Response Indonesia University Female 18 Years and older (Adult, Older Adult) 26 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IndonesiaU2022 19/08/2022 08/01/2024 02/01/2025 22/09/2022 26/09/2022 https://ClinicalTrials.gov/show/NCT05550415 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Indonesia Breast Breast Cancer - TNBC Simvastatin Biomarker Phase 2 DB00877 N
NCT04698941 Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy Unknown status Small Cell Lung Cancer Drug: Albumin Paclitaxel; Drug: Simvastatin Disease control rate (DCR); Overall response rate (ORR); Progression-free survival (PFS); Overall survival (OS); Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0 Shanghai Pulmonary Hospital, Shanghai, China; Chinese Academy of Sciences All 18 Years to 75 Years (Adult, Older Adult) 40 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2020LY021 25/07/2021 30/12/2021 30/12/2022 01/07/2021 29/07/2021 https://ClinicalTrials.gov/show/NCT04698941 Recurrent/Refractory Hospital/University/Research Institute N N N China Lung Small Cell Lung Cancer Simvastatin Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 2 DB00877 N
NCT05464810 Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Recruiting Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|HER2-Negative Breast Carcinoma|Hormone Receptor-Positive Breast Carcinoma|Invasive Breast Carcinoma Drug: Letrozole; Drug: Simvastatin Mean percentage change in Ki-67; Response per Ki-67; Change in the level of the following immune biomarkers: Percentage of CD8+ T cells, percentage of FOXp3 Treg cells, ratio of CD8+/Treg ratio; Patient-Reported Outcomes Measurement Information System (PROMIS) for pain; Incidence of adverse events Emory University; National Cancer Institute (NCI) Female 18 Years and older (Adult, Older Adult) 40 Other; NIH Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment STUDY00004257; NCI-2022-02545; WINSHIP5524-22; P30CA138292 09/02/2022 15/04/2025 15/04/2025 19/07/2022 12/05/2023 https://ClinicalTrials.gov/show/NCT05464810 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Breast Cancer - ER/HR+ Simvastatin Biomarker Phase 1 DB00877 N
NCT01441349 Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer Active, not recruiting Small Cell Lung Carcinoma Drug: IP chemotherapy; Drug: IP chemotherapy plus simvastatin 1-year survival rate; Tumor Response rate; Progression free survival; Toxicity profile National Cancer Center, Korea All 18 Years and older (Adult, Older Adult) 192 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCCCTS-11-527 08/01/2011 31/10/2022 31/12/2022 27/09/2011 04/06/2022 https://ClinicalTrials.gov/show/NCT01441349 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Korea, Republic of Lung Small Cell Lung Cancer Simvastatin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00877 N
NCT05821556 Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients Recruiting Adenocarcinoma of the Pancreas Drug: Valproic acid; Drug: Simvastatin 20mg; Drug: Gemcitabine 1000 mg; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Capecitabine Progression Free Survival (PFS); Objective Tumor Response Rate (ORR); Duration of Objective response (DOR); Disease Control Rate (DCR); Overall Survival (OS); Overall toxicity rate; Quality of Life (QoL) National Cancer Institute, Naples All 18 Years and older (Adult, Older Adult) 240 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VESPA; 1/23 06/12/2023 08/01/2025 06/01/2026 20/04/2023 15/06/2023 https://ClinicalTrials.gov/show/NCT05821556 Advanced/Metastatic Hospital/University/Research Institute Y N N Italy GI Pancreatic Cancer Simvastatin; Valproic Acid PFS Phase 2 DB00877; DB00177 N
NCT03433781 A Phase Ib/IIa Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations Active, not recruiting Myelodysplastic Syndromes Drug: 50 gm CIVI/24 hours x 5 days every 4 week Measure of serum bioavailability of Vitamin C in Myelodysplastic syndrome (MDS) patients with TET2 mutations NYU Langone Health; Perlmutter Cancer Center All 18 Years and older (Adult, Older Adult) 4 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 17-00978 05/01/2018 07/01/2025 07/01/2026 15/02/2018 21/03/2023 https://ClinicalTrials.gov/show/NCT03433781 Other (specify) Hospital/University/Research Institute N N N United States Other Haem-onc Myelodysplastic Syndromes Ascorbic acid Biomarker Phase 1/2 DB00335 N
NCT05754684 Quadruple Immunotherapy for Neuroblastoma Recruiting Neuroblastoma Recurrent Biological: Natural killer cell; Drug: Dinutuximab beta; Drug: Interleukin-2; Drug: Granulocyte-Macrophage Colony-Stimulating Factor; Drug: Spironolactone Proportion of patients who have objective response in the tumor; Overall survival at 1 year; Progression-free survival; Proportion of patients who have tumor relapse; Number of patients who experience adverse events; Percentage of donor NK cells Hong Kong Children's Hospital; The University of Hong Kong All up to 18 Years (Child, Adult) 29 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HKCH-REC-2021-007 01/01/2022 31/12/2024 31/12/2025 03/06/2023 03/06/2023 https://ClinicalTrials.gov/show/NCT05754684 Recurrent/Refractory Hospital/University/Research Institute N N N Hong Kong Other Neuroblastoma Spironolactone Response rate Phase 2 DB00795 N
NCT03993353 Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer Active, not recruiting Head and Neck Cancer|Head and Neck Squamous Cell Carcinoma|Head and Neck Carcinoma|Head and Neck Cancer Stage III|Head and Neck Cancer Stage IV|Head and Neck Cancer Metastatic|Cancer|Cancer of Esophagus|Cancer, Metastatic|Cancer of Head and Neck|Cancer of Mouth|Cancer of Neck Drug: Pembrolizumab; Drug: Tadalafil Rate of Dose Limiting Toxicity (DLT); Overall Survival (OS); Response measured by RECIST 1.1; Progression free survival; Adverse event rates University of California, San Diego All 18 Years and older (Adult, Older Adult) 6 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 190098 04/07/2020 12/01/2023 06/01/2024 20/06/2019 24/08/2023 https://ClinicalTrials.gov/show/NCT03993353 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Head and Neck Any head and neck squamous cell carcinoma Tadalafil Safety and/or Dose; Response rate; PFS; OS Phase 2 DB01079 N
NCT04691817 Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy Recruiting Lung Cancer, Nonsmall Cell Drug: Atezolizumab; Drug: Tocilizumab Overall response rate (ORR); Overall survival (OS); Dose Limiting Toxicities of the combination; Progression free survival (PFS). Abramson Cancer Center at Penn Medicine; Genentech, Inc. All 18 Years and older (Adult, Older Adult) 28 Other; Industry Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment UPCC 16520 25/07/2023 12/01/2025 09/01/2026 31/12/2020 28/07/2023 https://ClinicalTrials.gov/show/NCT04691817 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Tocilizumab Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB08895 N
NCT05846789 Phase II Trial of Carboplatin +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers Recruiting Metastatic Breast Cancer|Triple Negative Breast Cancer|Estrogen-receptor-low Breast Cancer Drug: Carboplatin; Drug: Tocilizumab Overall response rate; Efficacy of tocilizumab in Black and non-Black patients; Progression-free survival; Safety of carboplatin monotherapy compared to carboplatin combined with tocilizumab using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0; Evaluate the differences in inflammatory pathways between Black and non-Black patients; Evaluate the impact of Duffy genotype on efficacy in Black patients Kathy Miller; Genentech, Inc.; Indiana University All 18 Years and older (Adult, Older Adult) 168 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CTO-IUSCCC-0817 01/01/2024 12/01/2026 12/01/2027 05/06/2023 19/12/2023 https://ClinicalTrials.gov/show/NCT05846789 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Breast Cancer - TNBC Tocilizumab Response rate Phase 2 DB08895 N
NCT03821246 Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy Recruiting Prostate Adenocarcinoma|Prostate Cancer|Localized Prostate Cancer Drug: Atezolizumab; Drug: Tocilizumab; Drug: Etrumadenant Proportion of subjects who demonstrate a positive response to neoadjuvant atezolizumab and atezolizumab-based combination therapy for each Cohort of the study; Number of treatment-related of adverse events; Sum of Pathologic complete response (pCR) and Minimal residual disease (MRD) rate; Rate of Pathologic complete response (pCR) rate; Rate of Minimal residual disease (MRD); Prostate specific antigen (PSA) response Lawrence Fong; Genentech, Inc.; University of California, San Francisco Male 18 Years and older (Adult, Older Adult) 68 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 18702; NCI-2018-02805 30/10/2019 31/10/2024 31/10/2024 29/01/2019 10/12/2023 https://ClinicalTrials.gov/show/NCT03821246 Localised/Locoregional Company N Y N United States Urological Prostate Cancer Tocilizumab Safety and/or Dose; Response rate; Biomarker Phase 2 DB08895 N
NCT04940299 Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Active, not recruiting Clinical Stage III Cutaneous Melanoma AJCC v8|Clinical Stage IV Cutaneous Melanoma AJCC v8|Locally Advanced Bladder Carcinoma|Locally Advanced Bladder Urothelial Carcinoma|Locally Advanced Lung Non-Small Cell Carcinoma|Locally Advanced Renal Pelvis Carcinoma|Locally Advanced Renal Pelvis Urothelial Carcinoma|Locally Advanced Ureter Urothelial Carcinoma|Locally Advanced Urethral Urothelial Carcinoma|Malignant Solid Neoplasm|Metastatic Bladder Carcinoma|Metastatic Bladder Urothelial Carcinoma|Metastatic Lung Non-Small Cell Carcinoma|Metastatic Melanoma|Metastatic Renal Pelvis Urothelial Carcinoma|Metastatic Ureter Urothelial Carcinoma|Metastatic Urethral Carcinoma|Metastatic Urethral Urothelial Carcinoma|Pathologic Stage III Cutaneous Melanoma AJCC v8|Pathologic Stage IIIA Cutaneous Melanoma AJCC v8|Pathologic Stage IIIB Cutaneous Melanoma AJCC v8|Pathologic Stage IIIC Cutaneous Melanoma AJCC v8|Pathologic Stage IIID Cutaneous Melanoma AJCC v8|Pathologic Stage IV Cutaneous Melanoma AJCC v8|Stage III Bladder Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage III Renal Pelvis Cancer AJCC v8|Stage III Ureter Cancer AJCC v8|Stage III Urethral Cancer AJCC v8|Stage IIIA Bladder Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Bladder Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Bladder Cancer AJCC v8|Stage IV Lung Cancer AJCC v6|Stage IV Renal Pelvis Cancer AJCC v8|Stage IV Ureter Cancer AJCC v8|Stage IV Urethral Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8|Unresectable Melanoma Biological: Ipilimumab; Biological: Nivolumab; Biological: Tocilizumab Incidence of dose limiting toxicity; Occurrence of one or more grade 3 or higher adverse event in a given patient (Cohort 1); Best overall response; Progression-free survival (PFS); Overall survival (OS) M.D. Anderson Cancer Center All 18 Years and older (Adult, Older Adult) 35 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2020-1166; NCI-2021-04325 23/09/2021 31/12/2024 31/12/2024 25/06/2021 12/06/2023 https://ClinicalTrials.gov/show/NCT04940299 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung; Skin; Urological Urethral Cancer; Non-Small Cell Lung Cancer; Melanoma; Bladder Cancer Tocilizumab Safety and/or Dose Phase 2 DB08895 N
NCT04524871 A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) Recruiting Advanced Liver Cancers Drug: Atezolizumab; Drug: Bevacizumab; Drug: Tiragolumab; Drug: Tocilizumab; Drug: TPST-1120; Drug: RO7247669 2100 mg; Drug: RO7247669 600 mg; Drug: RO7247669 1200 mg dose; Drug: ADG126 Objective Response Rate (ORR); Progression Free Survival (PFS); Overall Survival (OS); OS at Specific Timepoints; Duration of Response (DOR); Disease Control; Percentage of Participants With Adverse Events During Stage 1; Percentage of Participants With Adverse Events During Stage 2 Hoffmann-La Roche; Adagene Inc; Tempest Therapeutics All 18 Years and older (Adult, Older Adult) 400 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment GO42216 11/02/2020 27/12/2025 27/12/2025 24/08/2020 01/09/2024 https://ClinicalTrials.gov/show/NCT04524871 Advanced/Metastatic Company N Y N United States GI Liver Cancer Tocilizumab Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 1/2 DB08895 N
NCT03708224 Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck Recruiting Cancer|Carcinoma|Squamous Cell Carcinoma|Head and Neck Cancer Biological: Atezolizumab; Biological: Tocilizumab; Biological: Tiragolumab Proportion of subjects with a >= 40 increase in the cluster of differentiation 3 (CD3) counts; R0 resection rate; Changes in immune parameters using mass cytometry (CyTOF), histology and gene expression; Changes in peripheral immune responses using CyTOF; Number of participants with treatment-related adverse events Alain Algazi; Genentech, Inc.; University of California, San Francisco All 18 Years and older (Adult, Older Adult) 55 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 177018; NCI-2018-01992; ML40180 03/08/2019 30/06/2027 30/06/2027 17/10/2018 17/01/2023 https://ClinicalTrials.gov/show/NCT03708224 Advanced/Metastatic Company N Y N United States Multiple cancer types Other multiple cancer group (specify) Tocilizumab Safety and/or Dose; Response rate; Biomarker; Other (specify) Phase 2 DB08895 N
NCT05207670 A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies MorningSun Recruiting Non-Hodgkin Lymphoma Drug: Mosunetuzumab (Cohorts A-C); Drug: Mosunetuzumab (Cohorts D-E); Drug: Tocilizumab Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B); Objective response rate (ORR), defined as the proportion of participants with a complete metabolic response (CMR) or partial response (PR), as determined by the investigator according to the Lugano Criteria 2014 (Cohorts C, D, and E); Overall survival (OS) (all cohorts); ORR, defined as the proportion pf participants with a CMR or PR, as determined by the investigator according to the Lugano Criteria 2014 (Cohorts A1, A2, and B); Time to response (TTR) (all cohorts); Duration of response (DOR) (all cohorts); DOR for participants with best response of CMR (all cohorts); Duration of complete response (DoCR) (all cohorts); Time to next treatment (TTNT) (all cohorts); PFS (all cohorts); Percentage of participants with adverse events (AEs) (all cohorts); Serum concentration of mosunetuzumab (all cohorts) Genentech, Inc. All 18 Years and older (Adult, Older Adult) 345 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ML43389 02/01/2022 31/07/2028 31/07/2028 26/01/2022 01/05/2024 https://ClinicalTrials.gov/show/NCT05207670 Any/All Stages Company N N N United States Lymphoma Follicular Lymphoma; Lymphoma - Other Tocilizumab Response rate; PFS; OS Phase 2 DB08895 N
NCT05391750 Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma Recruiting Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma Biological: Tocilizumab; Drug: Venetoclax Maximum tolerated dose (MTD); Incidence of adverse events (AEs); Overall response rate (ORR); Complete response rate; Time to response (TTR); Time to disease progression (TTP); Duration of response (DOR); Progression-free survival (PFS); Overall survival (OS) Emory University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 72 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00002448; NCI-2021-02510; WINSHIP5273-21; P30CA138292 19/10/2022 02/12/2026 02/12/2026 26/05/2022 26/01/2023 https://ClinicalTrials.gov/show/NCT05391750 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Tocilizumab Safety and/or Dose Phase 1 DB08895 N
NCT04729959 Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma Suspended Diffuse Astrocytoma, IDH-Wildtype|Recurrent Glioblastoma Biological: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Conventional Surgery; Radiation: Fractionated Stereotactic Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Tocilizumab Dose-limiting toxicities (Safety Run-In); Maximum-tolerated dose (Safety Run-In); Objective radiographic response rate (Phase II, Non-Surgical Cohort); Progression-free survival (PFS) (Phase II, Non-Surgical Cohort); Overall survival (Phase II, Non-Surgical Cohort); Progression-free survival (Phase II, Non-Surgical Cohort); Overall survival (Phase II, Surgical Cohort); Incidence of adverse events (Surgical Cohort and Non-Surgical Cohort) National Cancer Institute (NCI); NRG Oncology All 18 Years and older (Adult, Older Adult) 53 NIH; Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2021-00410; NRG-BN010; U10CA180868 03/11/2022 06/01/2025 06/01/2025 29/01/2021 01/11/2024 https://ClinicalTrials.gov/show/NCT04729959 Recurrent/Refractory Hospital/University/Research Institute N Y N United States CNS Astrocytoma; Glioblastoma Tocilizumab Safety and/or Dose; PFS; OS; Other (specify) Phase 2 DB08895 N
NCT04554771 Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy BASALT Active, not recruiting Esophageal Adenocarcinoma|Oesophageal Adenocarcinoma|Resectable Carcinoma Drug: Tocilizumab 20 Mg/mL Intravenous Solution; Drug: Paclitaxel; Drug: Carboplatin; Radiation: External beam radiotherapy Efficacy defined as pathological response to chemoradiotherapy according to the Mandard criteria; R0 resection rate; Progression free survival; Overall survival; Interleukin 6- Signal Transducer and Activator of Transcription 3 (IL6-STAT3) pathway inhibition measured by gene expression analysis; IL6-STAT3 pathway inhibition measured by immunohistochemistry; Levels of ADAM12 in tumor biopsies and serum; Incidence and severity of toxicity; Incidence and severity of radiation toxicity; Incidence and severity of post-operative complications; Feasibility completion; Feasibility withdrawal rate; Feasibility delay Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Noordwest Ziekenhuisgroep All 18 Years and older (Adult, Older Adult) 41 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NL74310.018.20; 2020-002909-25 27/01/2021 05/01/2023 01/01/2024 18/09/2020 19/12/2022 https://ClinicalTrials.gov/show/NCT04554771 Localised/Locoregional Hospital/University/Research Institute N Y N Netherlands GI Esophageal Cancer Tocilizumab Response rate; PFS; Biomarker; Other (specify) Phase 2 DB08895 N
NCT03193190 A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) Active, not recruiting Pancreatic Adenocarcinoma Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Drug: Atezolizumab; Drug: Cobimetinib; Drug: PEGPH20; Drug: BL-8040; Drug: Selicrelumab; Drug: Bevacizumab; Drug: RO6874281; Drug: AB928; Drug: Tiragolumab; Drug: Tocilizumab Percentage of Participants With Objective Response, as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1); Percentage of Participants With Adverse Events (AEs); Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1; Overall Survival; Percentage of Participants who are Alive at Month 6; Duration of Response, as Determined by Investigator According to RECIST v1.1; Percentage of Participants With Disease Control, as Determined by Investigator According to RECIST v1.1 Hoffmann-La Roche All 18 Years and older (Adult, Older Adult) 340 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment WO39608; 2016-004126-42 07/05/2017 31/10/2025 31/10/2026 20/06/2017 24/11/2023 https://ClinicalTrials.gov/show/NCT03193190 Advanced/Metastatic Company Y Y N United States GI Pancreatic Cancer Tocilizumab Safety and/or Dose; Response rate; PFS Phase 1/2 DB08895 N
NCT03869190 Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) Recruiting Urothelial Carcinoma|Bladder Cancer Drug: Atezolizumab; Drug: Enfortumab Vedotin; Drug: Niraparib; Drug: Magrolimab (Hu5F9-G4); Drug: Tiragolumab; Drug: Sacituzumab Govitecan; Drug: Tocilizumab; Drug: Cisplatin; Drug: Gemcitabine Objective Response Rate (ORR) for mUC Cohort Stage 1; pCR for Muscle Invasive Bladder Cancer (MIBC) Cohorts; Progression Free Survival (PFS) for mUC Cohort Stage 1; Overall Survival (OS) for mUC Cohort Stage 1; Overall Survival (at specific time-points) for mUC Cohort Stage 1; Duration of Response (DOR) for mUC Cohort Stage 1; Disease Control Rate (DCR) for mUC Cohort Stage 1; Percentage of Participants with Adverse Events for mUC Cohort Stage 1; Serum Concentration of Atezolizumab for mUC Cohort Stage 2; Serum Concentration of Enfortumab Vedotin for mUC Cohort Stage 2; Serum Concentration of Sacituzumab Govitecan for mUC Cohort Stage 2; Presence of ADAs to Atezolizumab for mUC Cohort Stage 2; Percentage of Participants with Adverse Events for mUC Cohort Stage 2; Landmark Recurrence-Free Survival (RFS) for MIBC Cohorts; Landmark Event-Free Survival (EFS) for MIBC Cohorts; Landmark Overall Survival (OS) for MIBC Cohorts; Percentage of Participants with Adverse Events for MIBC Cohorts Hoffmann-La Roche; Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas All 18 Years and older (Adult, Older Adult) 645 Industry; Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment WO39613 06/01/2019 12/06/2024 27/11/2027 03/11/2019 01/08/2024 https://ClinicalTrials.gov/show/NCT03869190 Advanced/Metastatic Company Y Y N United States Urological Bladder Cancer Tocilizumab Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 1/2 DB08895 N
NCT03999749 A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma Active, not recruiting Melanoma Drug: Ipilimumab; Drug: Nivolumab; Drug: Tocilizumab Antitumor activity of tocilizumab administered in combination with ipilimumab and nivolumab NYU Langone Health All 18 Years and older (Adult, Older Adult) 75 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 19-00008 06/11/2019 07/01/2023 11/01/2024 27/06/2019 14/11/2023 https://ClinicalTrials.gov/show/NCT03999749 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Tocilizumab Other (specify) Phase 2 DB08895 N
NCT04116411 A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients VIGAS2 Recruiting Glioblastoma Multiforme Drug: Valganciclovir Tablets; Drug: Temozolomide 120 mg; Radiation: Radiotherapy 60 Gy; Drug: Placebo oral tablet Impact of valganciclovir on median overall survival of glioblastoma patients; Baseline and demographic data; Progression free survival at 12 and 24 months; Incidence of valganciclovir treatment related adverse events; Health related Quality of Life using EORTC QLQ30 module; Cognitive functions; Health related Quality of Life using the EORTC BN20 module Cecilia Soderberg-Naucler; Karolinska University Hospital; Karolinska Institutet All 18 Years and older (Adult, Older Adult) 220 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment Eudra CT: 2019-001083-30 09/04/2019 31/08/2024 31/08/2024 10/04/2019 13/09/2021 https://ClinicalTrials.gov/show/NCT04116411 Localised/Locoregional Hospital/University/Research Institute Y N N Sweden CNS Glioblastoma Valganciclovir Safety and/or Dose; PFS; OS; QoL Phase 2 DB00313 N
NCT05595473 A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Hepatocellular Carcinoma Recruiting Hepatocellular Carcinoma Drug: RZ-001 Dose 1; Drug: RZ-001 Dose 2; Drug: RZ-001 Dose 3; Drug: RZ-001 Dose 4 Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE; To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) for participants in part 2 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) in part 2 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of participants in part 2 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of participants in part 2 as graded by RECIST v1.1 and mRECIST; Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE; To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST; To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST Rznomics, Inc. All 18 Years and older (Adult, Older Adult) 42 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment RZ-001 29/07/2022 03/01/2029 05/01/2029 27/10/2022 27/10/2022 https://ClinicalTrials.gov/show/NCT05595473 Localised/Locoregional Company N N N Korea, Republic of GI Liver Cancer Valganciclovir Safety and/or Dose; Response rate Phase 1/2 DB00313 N
NCT04590664 Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma Recruiting Glioblastoma|Recurrent Glioblastoma Drug: Verteporfin Incidence of adverse events (Phase I); Progression free survival (PFS) (Phase II); Response rate (RR) (Phase II); Overall survival (Phase II); PFS (Phase I); RR (Phase I); Overall survival (Phase I); Visudyne blood levels (Phase I); Incidence of adverse events (Phase II) Emory University; National Cancer Institute (NCI) All 18 Years and older (Adult, Older Adult) 24 Other; NIH Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00000974; NCI-2020-05187; WINSHIP5070-20; P30CA138292 15/01/2021 15/08/2024 15/08/2025 19/10/2020 22/02/2023 https://ClinicalTrials.gov/show/NCT04590664 Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioblastoma Verteporfin Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00682 N
NCT05953350 A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i Recruiting Inhibition of Autophagy Synergizes Anti-tumor Effect Drug: 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib; Drug: RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial. The safety dose of the combination of hydroxychloroquine and CDK4/6 inhibitors in patients; the recommended phase II dose; Objective response rate ORR ; Progression-free survival (PFS) Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University All 18 Years and older (Adult, Older Adult) 29 Other Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SKSKY-2023-488-01 06/12/2023 31/12/2023 31/12/2024 20/07/2023 13/12/2023 https://ClinicalTrials.gov/show/NCT05953350 Advanced/Metastatic Hospital/University/Research Institute N N N China Multiple cancer types Any solid tumours Hydroxychloroquine Safety and/or Dose; Response rate; PFS Phase 1/2 DB07118 N
NCT04539808 NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer Recruiting Pancreatic Adenocarcinoma|Stage 0 Pancreatic Cancer AJCC v8|Stage I Pancreatic Cancer AJCC v8|Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8 Drug: Capecitabine; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Losartan Potassium; Drug: Oxaliplatin; Radiation: Radiation Therapy; Procedure: Resection; Procedure: Diagnostic Imaging; Procedure: Biospecimen Collection Proportion of participants with R0 resection; Progression-free survival (PFS) NeoOPTIMIZE; PFSNeoOPTIMIZE + pre-operative (preop)-RT; Disease-free survival (DFS) NeoOPTIMIZE; DFSNeoOPTIMIZE + preop-RT; Overall survival (OS) NeoOPTIMIZE; OSNeoOPTIMIZE + preop-RT; Proportion of participants with peri- and post-operative complications; Proportion of participants that die within 30 days of surgery; Incidence of grade >= 3 toxicities OHSU Knight Cancer Institute; Oregon Health and Science University All 18 Years and older (Adult, Older Adult) 60 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STUDY00021614; NCI-2020-06277 27/05/2021 15/04/2024 10/05/2025 09/07/2020 15/11/2023 https://ClinicalTrials.gov/show/NCT04539808 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Losartan Other (specify) Phase 2 DB00227 N
NCT05564377 Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Recruiting Advanced Malignant Solid Neoplasm|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IV Breast Cancer AJCC v8|Locally Advanced Malignant Solid Neoplasm|Malignant Female Reproductive System Neoplasm|Metastatic HER2-Negative Breast Carcinoma|Metastatic Malignant Solid Neoplasm|Recurrent Endometrial Carcinoma|Recurrent Fallopian Tube Carcinoma|Recurrent Malignant Female Reproductive System Neoplasm|Recurrent Malignant Solid Neoplasm|Recurrent Ovarian Carcinoma|Recurrent Primary Peritoneal Carcinoma|Unresectable HER2-Negative Breast Carcinoma|Unresectable Malignant Solid Neoplasm Drug: Alpelisib; Drug: Binimetinib; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography; Drug: Fluorouracil; Drug: Fulvestrant; Drug: Ipatasertib; Drug: Leucovorin; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Mutation Carrier Screening; Drug: Neratinib Maleate; Drug: Nilotinib Hydrochloride Monohydrate; Drug: Olaparib; Drug: Oxaliplatin; Drug: Paclitaxel; Drug: Palbociclib; Biological: Panitumumab; Procedure: Positron Emission Tomography; Drug: Selumetinib Sulfate; Drug: Sotorasib Accrual of patients to ComboMATCH treatment trials; Assignment of patients to ComboMATCH treatment trials; Enrollment rates to ComboMATCH treatment trials; Rate of positive outcomes within the treatment trial defined cohorts National Cancer Institute (NCI) All Child, Adult, Older Adult 2900 NIH Interventional Study Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Screening NCI-2022-06842; EAY191; U10CA180820 04/07/2023 07/01/2030 07/01/2030 10/03/2022 01/09/2024 https://ClinicalTrials.gov/show/NCT05564377 Advanced/Metastatic; Recurrent/Refractory Local/National government N N N United States Multiple cancer types Any solid tumours Selumetinib PFS; Other (specify) Phase 2 DB01104 N
NCT05091424 A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia Recruiting Chronic Lymphocytic Leukemia Drug: Mosunetuzumab; Drug: Tocilizumab; Drug: Venetoclax Rate of Dose-Limiting Toxicities (DLTs); Objective Response Rate (ORR); Minimal Residual Disease (MRD) Response Rate; Progression-Free Survival (PFS); Overall Survival (OS); Event-Free Survival (EFS); Complete Response (CR) Rate; Duration of Response (DOR); Percentage of Participants with Adverse Events (AEs); Maximum Serum Concentration (Cmax) of Mosunetuzumab SC; Minimum Serum Concentration (Cmin) of Mosunetuzumab SC; Time to Maximum Concentration (Tmax) of Mosunetuzumab SC; Incidence of Anti-Drug Antibodies (ADAs) Hoffmann-La Roche All 18 Years and older (Adult, Older Adult) 137 Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment BO43243 03/07/2022 27/05/2027 10/08/2029 25/10/2021 21/12/2023 https://ClinicalTrials.gov/show/NCT05091424 Recurrent/Refractory Company N N N Spain Leukemia Chronic Lymphocytic Leukemia Tocilizumab Safety and/or Dose Phase 1 DB08895 N
NCT05166577 Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC Recruiting Nasopharyngeal Carcinoma|EBV-Related Gastric Carcinoma|EBV-Related Leiomyosarcoma|EBV Related Carcinoma|EBV-Related Sarcoma Drug: Nanatinostat; Drug: Valganciclovir; Drug: Pembrolizumab Phase 1b: Incidence of dose-limiting toxicities (DLTs); Phase 2: Overall response rate (ORR); Incidence and severity of adverse events; Duration of response (DOR); Disease control rate (DCR); Progression-free survival (PFS); Overall survival (OS); Pharmacokinetic parameter - time to maximum plasma concentration [tmax]; Pharmacokinetic parameter - maximum plasma concentration [Cmax]; Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC] Viracta Therapeutics, Inc. All 18 Years and older (Adult, Older Adult) 130 Industry Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment VT3996-301 10/07/2021 12/01/2024 10/01/2025 22/12/2021 12/11/2023 https://ClinicalTrials.gov/show/NCT05166577 Advanced/Metastatic Company N Y N United States Head and Neck Nasopharyngeal Cancer Valganciclovir Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 1/2 DB00313 N
NCT06157099 Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA Melanoma Not yet recruiting Clinical Stage IIA Cutaneous Melanoma AJCC v8 Drug: Atorvastatin; Drug: Placebo Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Electronic Health Record Review Recurrence-free survival (RFS); Distant metastasis-free survival (DMFS); Overall survival (OS) OHSU Knight Cancer Institute; Oregon Health and Science University; Kuni Foundation All 18 Years and older (Adult, Older Adult) 150 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment STUDY00025369; NCI-2023-03875 01/01/2024 03/01/2028 03/01/2029 12/05/2023 12/05/2023 https://ClinicalTrials.gov/show/NCT06157099 Localised/Locoregional Hospital/University/Research Institute Y N N United States Skin Melanoma Atorvastatin OS; DFS/RFS/EFS; Other (specify) Phase 2 DB01117 N
NCT06148038 CBD for Breast Cancer Primary Tumors Not yet recruiting Breast Cancer Drug: CBD Oral; Other: Control CBD and cell proliferation; CBD and apoptosis; Number of participants with treatment-related adverse events as assessed by CTCAE 5.0; GAD-7 anxiety level scoring at Pre and post CBD administration Medical University of South Carolina All 18 Years and older (Adult, Older Adult) 60 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 103565 31/01/2024 30/09/2025 30/09/2026 28/11/2023 12/12/2023 https://ClinicalTrials.gov/show/NCT06148038 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Cannabidiol Biomarker Phase 1 DB01197 N
NCT06076837 The Seven Trial: Exploiting the Unfolded Protein Response Not yet recruiting Pancreatic Cancer Metastatic|Pancreatic Adenocarcinoma Metastatic Drug: Botensilimab; Drug: Balstilimab; Drug: Chloroquine Phosphate; Drug: Celecoxib Maximum Tolerated Dose (MTD); Safety and Tolerability; Complete Response (CR); Overall Response Rate (ORR); Progression free survival (PFS); Overall Survival (OS); Disease Control Rate (CR), Partial Response (PR), and Stable Disease (SD); CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) HonorHealth Research Institute; Translational Genomics Research Institute; University of Arizona; Agenus Inc. All 18 Years and older (Adult, Older Adult) 12 Other; Industry Interventional Study Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HRI-SevenTrial 12/01/2023 06/01/2025 12/01/2025 10/11/2023 10/11/2023 https://ClinicalTrials.gov/show/NCT06076837 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Celecoxib; Chloroquine Safety and/or Dose; Response rate; OS; Biomarker Phase 1 DB00567; DB00477 N
NCT06126731 Combination Study of Antibiotics With Enzalutamide (PROMIZE) Recruiting Metastatic Castration-Resistant Prostate Cancer (mCRPC) Drug: Enzalutamide 40mg; Drug: Amoxicillin 500mg; Drug: Metronidazole 400mg; Drug: Vancomycin 125mg; Drug: Ciprofloxacin 500g Confirm the safety and tolerability of the combination of amoxicillin plus metronidazole (2 weeks) followed by ciprofloxacin plus vancomycin (2 weeks) along with enzalutamide in Phase I in mCRPC patients.; Describe the safety profile of the antibiotic combinations along with enzalutamide in Phase I.; Determine the response rate of the antibiotic combinations in patients with mCRPC in Phase II.; To document possible anti-tumour activity in patients in Phase I.; To evaluate progression-free survival (PFS) in mCRPC patients receiving the antibiotic combinations in Phase I.; To evaluate PFS in mCRPC patients receiving the antibiotic combinations along with enzalutamide in Phase II.; To determine the time to PSA progression from the date of antibiotic commencement; To determine the duration of PSA decline as an estimate of the biochemical anti-tumour activity of the combination of amoxicillin plus metronidazole (2-weeks) followed by ciprofloxacin plus vancomycin (2-weeks) along with enzalutamide.; To determine the maximum percentage and absolute PSA decline from baseline; To determine the radiologic PFS (rPFS) of the combination of antibiotics and enzalutamide in Phase II.; To determine the time to radiologic progression to the combination of antibiotics and enzalutamide in Phase II.; To estimate the OS in mCRPC patients receiving the antibiotic combinations along with enzalutamide in Phase II.; To further characterise the safety and tolerability profile of the antibiotic combinations with enzalutamide in Phase II.; To identify biomarkers of response to the antibiotic combinations and of anti-tumour activity in Phase II.; To evaluate the peripheral circulation neutrophil-to-lymphocyte ratio (NLR) as a determinant of response to to treatment in Phase II. Institute of Cancer Research, United Kingdom; Prostate Cancer Foundation Male 18 Years and older (Adult, Older Adult) 39 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CCR5461 11/02/2023 30/06/2024 31/07/2025 13/11/2023 13/11/2023 https://ClinicalTrials.gov/show/NCT06126731 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United Kingdom Urological Prostate Cancer Ciprofloxacin; Metronidazole Safety and/or Dose; Response rate Phase 1/2 DB00215; DB01011 N
NCT06084780 Intestinal Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE) TRANSCAPE Not yet recruiting Secondary Malignant Neoplasm of Retroperitoneum|Secondary Malignant Neoplasm of Peritoneum|Pseudomyxoma Peritonei Procedure: Intestinal, Multivisceral or Modified Multivisceral Transplantation; Drug: Alemtuzumab; Drug: Tacrolimus; Drug: Sirolimus Overall Rate of Survival; Overall Rate of Morbidity; Overall Rate of Mortality Case Comprehensive Cancer Center All 18 Years to 75 Years (Adult, Older Adult) 20 Other Interventional Study Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CASE7Z23 04/01/2024 31/12/2025 31/12/2025 16/10/2023 16/10/2023 https://ClinicalTrials.gov/show/NCT06084780 Advanced/Metastatic Hospital/University/Research Institute N N N United States Other Other Sirolimus OS; Other (specify) Phase 2 DB01261 N
NCT06150898 Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt) KePreSt Not yet recruiting Early-stage Breast Cancer|Estrogen-receptor-positive Breast Cancer Procedure: Prospective data and sample collection; Drug: Ketorolac 10 Mg Oral Tablet; Drug: Pregabalin 75mg To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac; To detect a reduced increase in systemic neurotransmitters (from baseline to up to 24 hours after surgery) using peri-operative pregabalin; Change in biomarkers of metastasis at surgery from baseline; Change in tumoral immune cells recruitment at surgery from baseline; Change in tumoral neurogenesis at surgery from baseline; Change in tumoral neurotransmitters level at surgery from baseline; Change in Peripheral Blood Mononuclear Cells at surgery from baseline; Change in systemic neuro-inflammatory mediators at surgery from baseline; Change in systemic neurotransmitters at surgery from baseline; Change in anxiety level at surgery from baseline; Post-operative pain Jules Bordet Institute; KU Leuven; University of Milan Female 18 Years to 70 Years (Adult, Older Adult) 112 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other IJB-KEPREST-2022 20/02/2024 20/07/2026 12/01/2026 29/11/2023 29/11/2023 https://ClinicalTrials.gov/show/NCT06150898 Localised/Locoregional Hospital/University/Research Institute N N N France Breast Breast Cancer - ER/HR+ Ketorolac Biomarker Phase 2 DB00555 N
NCT06099769 A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer Recruiting Metastatic Breast Cancer Drug: Enzalutamide; Drug: Mifepristone; Drug: TPC progression-free survival (PFS) Memorial Sloan Kettering Cancer Center; Astellas Pharma US, Inc.; Breast Cancer Research Foundation; Corcept Therapeutics All 18 Years and older (Adult, Older Adult) 201 Other; Industry Interventional Study Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 22-334 18/10/2023 10/01/2027 10/01/2027 25/10/2023 14/12/2023 https://ClinicalTrials.gov/show/NCT06099769 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Breast Breast Cancer - TNBC Mifepristone PFS Phase 2 DB09031 N
NCT06176339 Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients Not yet recruiting Breast Cancer Female Drug: Pentoxifylline Oral Tablet; Drug: Placebo Relative reduction in tumor size after neoadjuvant chemotherapy treatment; The number of patients achieving a pathological complete response; The relative change of left ventricular ejection fraction (LVEF); The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5; The relative change of liver function tests; The change in Serum Creatinine concentration Mansoura University All 18 Years to 65 Years (Adult, Older Adult) 70 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment 2023-147-1 15/12/2023 30/08/2024 30/09/2024 19/12/2023 19/12/2023 https://ClinicalTrials.gov/show/NCT06176339 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Pentoxifylline Safety and/or Dose; Other (specify) Phase 2 DB08883 N
NCT06134388 Sulfasalazine in Patients With Metastatic Colorectal Cancer Recruiting Metastatic Colorectal Cancer Drug: Sulfasalazine Evaluating the change in the serum level of Ferritin; Evaluating the change in the serum level of Superoxide dismutase (SOD); Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB); Evaluating the change in the serum level of Bcl-2 associated X protein (Bax); Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR).; Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR).; Evaluating the progression free survival (PFS); Evaluating the one-year overall survival (1-year OS); Evaluating the safety and tolerability of sulfasalazine through investigating Hematological parameters (hemoglobin (mg/dL), erythrocytes (cells/ L), leukocytes (cells/ L), platelets (cells/ L) and absolute neutrophil count (cells/ L)).; Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test.; Evaluating the safety and tolerability of sulfasalazine through investigating Renal function test (serum creatinine (mg/dL), blood urea nitrogen (mg/dL) and creatinine clearance (mL/min)). Tanta University All 18 Years to 65 Years (Adult, Older Adult) 50 Other Interventional Study Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Sulfasalazine 2023 09/01/2023 09/01/2025 09/01/2026 18/11/2023 18/11/2023 https://ClinicalTrials.gov/show/NCT06134388 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Sulfasalazine Response rate; PFS; OS; DFS/RFS/EFS; Biomarker Phase 3 DB00605 N
2018-004119-36 Altered tumor oxygenation by Metformin, a potential step in overcoming radiotherapy resistance in locally advanced cervical cancer. Ongoing Locally advanced cervical cancer Drug: Glucophage To determine if one week of metformin treatment can change tumor hypoxia-related gene expression signature Oslo University Hospital Female Adult 18-64 90 Oslo University Hospital - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004119-36/NO Localised/Locoregional Hospital/University/Research Institute Y N N Norway Gynaecological Cervical Cancer Metformin Biomarker Phase 2 DB00703 N
2014-000349-59 METAL (METformin in Advanced Lung cancer) study: PHASE II STUDY OF METFORMIN PLUS ERLOTINIB IN SECOND LINE THERAPY OF STAGE IV NON SMALL CELL LUNG CANCER (NSCLC) PATIENTS Ongoing Patients with metastatic non small cell lung cancer in second line therapy Drug: erlotinib The study is a two-part trial, where a safety Run-in part of metformin combined with erlotinib will be followed by a Phase II part of metformin plus erlotinib. Primary objective of the safety run in part is to determine the MTD and the recommended Phase II dose of metformin combined with erlotinib as second-line treatmentin subjects with NSCLC harboringwild-type EGFR gene. Primaryobjective of the phase II part are: bull; To assess the percentage of patientswithoutdiseaseprogressionat 10 weeks. bull; To assess the median progression free survival of the second-line combination metformin and erlotinib in subjects with NSCLCharboring wild-type EGFR gene. department of experimental and clinical medicine F. Magrassi All Adult 18-64; Elderly 65+ 60 department of experimental and clinical medicine F. Magrassi - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000349-59/IT Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Italy Lung Non-Small Cell Lung Cancer Metformin Safety and/or Dose Phase 2 DB00703 N
2014-005193-11 METformin And Longevity (METAL): A window of opportunity study investigating biological effects of metformin in localised prostate cancer METAL GB - no longer in EU/EEA Prostate cancer Drug: Metformin hydrocholride; Placebo Assessment of the difference in expression levels of markers of the FASN/AMPK pathway pre and post treatment between the placebo and metformin arms. King's College London Male Adult 18-64 105 JP Moulton Charitable Foundation - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005193-11/GB Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom Urological Prostate Cancer Metformin Biomarker Phase 4 DB00703 N
2006-006236-22 Use of Metformin to reduce serum level of Testosterone and improve the metabolic picture in women treated for breast cancer Metformin and serum Testosterone in women with breast cancer Ongoing Menopausal women on treatment for BC, with higher risk of recurrence due to augmented level of T Drug: Metformin To define the smallest dose of Metformin able to reduce augmented serum level of Testosterone in women on treatment for breast cancer AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA Female Adult 18-64 250 - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-006236-22/IT Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Any Breast Cancer Metformin Safety and/or Dose Phase 2 DB00703 N
2009-017716-32 A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer metformin and pancreatic cancer Ongoing locally advanced and metastatic pancreatic cancer Drug: erlotinib; Drug: gemcitabine; Placebo survival after 6 months Academic Medical Center All Adult 18-64 120 - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017716-32/NL Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Netherlands GI Pancreatic Cancer Metformin OS Phase 2 DB00703 N
2011-004683-30 A phase II study of sorafenib and metformin in patients with locally advanced and/or metastatic non-smal cell lung cancer (NSCLC) with a K-Ras mutation Phase II study of combined treatment of sorafenib and metformin in NSCLC Ongoing Patients with advanced non small cell lung cancer that harbours a K-Ras mutation Drug: nexavar; Drug: SORAFENIB The main endpoint of the study is the rate of no progression at 6 weeks (NPR). This NPR is defined as the rate of subjects without progression (based on RECIST criteria) at 6 weeks after start of treatment VU University Medical All Adult 18-64 64 Bayer Healthcare AG - https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004683-30/NL Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands Lung Non-Small Cell Lung Cancer Metformin Other (specify) Phase 2 DB00703 N
2009-014662-26 Phase II comparative study of Myocet plus Cyclophosphamide plus metformin versus Myocet plus Cyclophosphamide in first line treatment of HER2 negative metastatic breast cancer patients. MYME Ongoing HER2 negative metastatic breast cancer patients Drug: Doxorubicin; Drug: Cyclophosphamide progression free survival ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI Female Adult 18-64; Elderly 65+ 112 - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014662-26/IT Advanced/Metastatic Hospital/University/Research Institute Y N N Italy Breast Breast Cancer - HER2- Metformin PFS Phase 2 DB00703 N
2014-002602-20 CLINICAL AND TRASLATIONAL PHASE II STUDY OF LIPOSOMAL DOXORUBICIN PLUS DOCETAXEL AND TRASTUZUMAB WITH METFORMIN AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER. met-HEReMYTA Ongoing OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER. Drug: 3'-desosssi-3'-[F-18] fluorotimidina (FLT); Drug: NA; Drug: ND Pathologic complete response rate (pCR). ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS All Adult 18-64 46 IRST-IRCCS - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002602-20/IT Localised/Locoregional Hospital/University/Research Institute N N N Italy Breast Breast Cancer - HER2+ Metformin Response rate Phase 2 DB00703 N
2020-005088-30 STOP-LEUKEMIA: A pilot study of metformin as a leukemia-preventive drug in patients with CCUS or LR-MDS STOP-LEUKEMIA Ongoing Clonal cytopenia of undetermined significance (CCUS) and lower-risk myelodysplastic syndrome (LR-MDS). The primary endpoints of WP1 are: Feasibility A quantitative and qualitative feasibility assessment will be undertaken to inform the decision to proceed with a RCT to assess the effect of this intervention. 1. To estimate recruitment and refusal rates and 12 months follow-up rates. 2. To determine how many participants receive the intervention. 3. To estimate protocol adherence. 4. To explore, qualitatively, the acceptability of interventions and assessments with patients. Safety 1. To describe the type, grade and number of adverse events and serious adverse events in the patients. 2. To assess any suspected unexpected serious adverse reactions. 3. To estimate drop-out rates. 4. To describe any changes in individual medication doses including median maximum tolerated dose. Kirsten Gr oslash;nb aelig;k All Adult 18-64 60 Rigshospitalet - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005088-30/DK Any/All Stages Hospital/University/Research Institute N N N Denmark Other Haem-onc Myelodysplastic Syndromes Metformin Biomarker Phase 2 DB00703 N
2020-002468-30 Study of Metformin activity in patients with differentiated thyroid cancer metastasis with minimally progressive development Metformin in patients with DTC Ongoing patients with differentiated thyroid cancer metastasis with minimally progressive development Drug: Glucophage unidie 1000 MG 1) Progression-free survival (PFS); 2) Tg levels have been trending over time. ENTE OSPEDALIERO OSPEDALI GALLIERA All Adult 18-64 20 - https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002468-30/IT Advanced/Metastatic Hospital/University/Research Institute N N N Italy Endocrine Thyroid Cancer Metformin PFS Phase 2 DB00703 N
2011-000490-30 Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer. Ongoing Women with stage II-III, HER2/ErbB2-positive primary breast cancer elegible for neoadjuvant treatment. Drug: METFORMINA HIDROCLORURO; Drug: TRASTUZUMAB -Pathological Complete Response Rate (pCR) . Percentage of patients who present pathological complete response, defined as the absence of infiltrating carcinoma in resected materials and the axilla or the exclusive presence of in situ non-invasive cancer in resected material (number of patients with pCR)/(total patient numbers according to per protocol population) x 100 Institut Catal agrave; d'Oncologia Female Adult 18-64 178 Ministerio de Sanidad, Politica Social e Igualdad - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-000490-30/ES Localised/Locoregional Hospital/University/Research Institute Y N N Spain Breast Breast Cancer - HER2+ Metformin Response rate Phase 2 DB00703 N
2018-000788-95 Exploiting metformin plus/minus cyclic FAsting Mimicking diet (FMD) to improve the Efficacy of platinum-pemetrexed chemotherapy in advanced LKB1-mutated lung adenocarcinoma: the FAME trial FAME trial Ongoing Patients with LKB1-mutated advanced lung adenocarcinomas Drug: METFORMINA Progression-free survival (PFS) FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI All Adult 18-64 88 AIRC 5x1000 - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000788-95/IT Advanced/Metastatic Hospital/University/Research Institute Y N N Italy Lung Non-Small Cell Lung Cancer Metformin PFS Phase 2 DB00703 N
2018-004385-34 Neoadjuvant Aspirin and/or Metformin during preoperative induction chemotherapy and chemoradiotherapy for locally-advanced rectal cancer. A multi-arm, multi-stage, intergroup (STAR-04/SICO-CR01/GISCAD) randomised clinical trial. NeoAspMet Ongoing LOCALLY ADVANCED RECTAL CANCER PATIENTS IN STAGE II/III Drug: METFORMINA; Drug: XELODA Primary endpoint is Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE All Adult 18-64 340 Istituto Nazionale Tumori - Fondazione G.Pascale, IRCCS Napoli - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004385-34/IT Advanced/Metastatic Hospital/University/Research Institute Y Y N Italy GI Rectal Cancer Acetylsalicylic Acid; Metformin Response rate Phase 2 DB01048; DB00703 N
2017-003028-59 Treatment with Recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with Anaplastic Thyroid Cancer: a proof of concept study ATC-Anakinra1 Ongoing Anaplastic Thyroid Carcinoma Drug: Kineret Health Related Quality of Life (HR-QoL): defined as outcome of the QoL life questionnaire specifically designed for anaplastic thyroid cancer patients Tumor dimensions/tumor progression: TNM classification and tumor size etc. This will be assessed using radiological examinations using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria . Overall survival (OS): defined as time interval from date of official inclusion to death due to any cause. Radboud University Medical Centre All Adult 18-64 10 Radboud University Medical Centre - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003028-59/NL Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands Endocrine Thyroid Cancer Anakinra QoL; Other (specify) Phase 4 DB00673 N
2014-005508-62 A phase II, randomized, non-comparative, pre-surgical study of atorvastatin or observation in Ki-67 positive, TAZ-expressing early breast cancer patients TRINACRIA TRIAL Ongoing Early breast cancer Drug: ATORVASTATINA the rate of Ki-67 reduction below the 15 ISTITUTI FISIOTERAPICI OSPITALIERI Female Adult 18-64 78 Istituto Regina Elena - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005508-62/IT Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Any Breast Cancer Atorvastatin Biomarker Phase 2 DB01117 N
2020-003152-33 A phase II trial of long-term intravenous treatment with bi-weekly Azithromycin in patients with gastric lymphoma of the mucosa associated lymphoid tissue (MALT-lymphoma) Ongoing gastric MALT Lymphoma Drug: AZITHROMYCIN DIHYDRATE Primary endpoint: rate of objective responses (as judged by best response during the study period) rarr; Clinical response measured according to standard criteria (RECIST 1.1, GELA Med. Univ. Wien All Adult 18-64 46 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003152-33/AT Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Austria Lymphoma Lymphoma - Other Azithromycin Response rate Phase 2 DB06401 N
2019-004074-25 A Phase II Open-Label Randomized COntrolled Pre-Surgical Feasibility Study of Antibiotic COmbinations in Early Breast Cancer ABC2 Ongoing We investigated, in a population of patients with breast cancer, the combined effect of azithrocyn, docyciclin and vitamin C on biomarkers associated with cell proliferation Drug: Azitromicina; Drug: vitamina C; Drug: DOXICICLINA ICLATO Reduction in Ki67 expression in post-treatment tumor samples compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA Female Adult 18-64; Elderly 65+ 90 Lunella Biotech - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004074-25/IT Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Any Breast Cancer Ascorbic acid; Azithromycin Biomarker Phase 2 DB00335; DB06401 N
2018-004505-34 A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10 / CBD 5 ) in patients with advanced untreatable hepatocellular carcinoma Medicinal cannabisoil for untreatable HCC patients Ongoing The anti-tumoral effect of cannabis oil will be investigated in patients with untreatable HCC Drug: Transvamix ; Drug: Cannabidiol to study the anti-tumor effect of cannabis oil (THC10 / CBD5 ) in untreatable HCC patients by assessing tumor size at 6 months after starting treatment based on RECIST and mRECIST criteria University Medical Center Groningen All Adult 18-64 20 Hubregste stichting - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004505-34/NL Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands GI Liver Cancer Cannabidiol Response rate Phase 2 DB01197 N
2019-001071-37 Open label, phase II, Proof of Concept study of neoadjuvant celecoxib in newly diagnosed patients with endometrial carcinoma Acronym: Celebrido CELEBRIDO Ongoing Patients with confirmed primary endometrioid adenocarcinoma eligible for first line curative surgery Drug: Celecoxib Decrease in the proportion of IDO1+ tumour cells by ge;50 , and increase in the proportion of CD3+ T-cells infiltrating the tumor bed by ge;50 following celecoxib treatment, as measured by immunostaining and computerized analysis of digitized histological images Cliniques Universitaires Saint-Luc Female Adult 18-64 48 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001071-37/BE Localised/Locoregional Hospital/University/Research Institute N N N Belgium Gynaecological Endometrial Cancer Celecoxib Biomarker Phase 2 DB00567 N
2019-000572-41 An open label phase II study combining anti-PD-1 or PD-L1 and Celecoxib in patients with advanced laquo; cold raquo; solid tumors NICE-COMBO Ongoing Indication of treatment with anti-PD1 antibodies such as bull; Melanoma non BRAF mutated in first line of treatment bull; Melanoma BRAF mutated in first or second line of treatment bull; Lung cancer (NSCLC) in second line of treatment bull; Renal cell Cancer (RCC) in second line of treatment bull; Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy bull; Bladder cancer after platinum salt based chemotherapy bull; Endometrial carcinoma bull; Squamous cell skin carcinoma bull;Merkel cell carcinoma Drug: CElecoxib Overall response rate (ORR), defined as the percentage of subjects having a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per RECIST v1.1. Cliniques Universitaires Saint-Luc All Adult 18-64 68 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000572-41/BE Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Belgium Skin; Lung; Urological; Head and Neck Melanoma; Non-Small Cell Lung Cancer; Renal Cell Carcinoma; Bladder Cancer; Any head and neck squamous cell carcinoma Celecoxib Response rate Phase 2 DB00567 N
2006-004465-33 Oral Celecoxib combined with BCG instillation therapy in treatment of carcinoma in situ (CIS), TaG3 and T1 disease of urinary bladder Ongoing invasive bladder cancer Drug: CELECOXIB; Placebo Eero Kaasinen All Adult 18-64 300 - Contolled|Randomised|Placebo|Double blind|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-004465-33/FI Localised/Locoregional Hospital/University/Research Institute Y N N Finland Urological Bladder Cancer Celecoxib Other (specify) Phase 2/3 DB00567 N
2005-000717-35 COX-2-h auml;mmare och kemoterapi vid avancerad icke sm aring;cellig lungcancer. En prospektiv randomiserad dubbel-blind studie. Key elements: CYclooxygenase-2 inhibitor, Chemotherapy, LUng cancer, Survival (CYCLUS-studien) CYCLUS-studien Ongoing Histologiskt eller cytologiskt veriferad icke sm aring;cellig lungcancer, stadium IIIB-IV, som inte kan behandlas med operation eller kurativt syftande str aring;lbehandling. WHO performance status 0-2. Drug: celecoxib; Placebo Prim auml;r auml;ndpunkt: Ouml;verlevnad Lungmedicinska kliniken All Adult 18-64 760 - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-000717-35/SE Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N Sweden Lung Non-Small Cell Lung Cancer Celecoxib OS Phase 3 DB00567 N
2006-004478-29 DOCETAXEL AND PREDNISON IN ASSOCIATION WITH METRONOMIC THERAPY WITH CICLOPHOSPHAMIDE AND CELECOXIN IN HORMONE-REFRACTORY PROSTATIC CANCER PATIENTS : PHASE II CLINICAL TRIAL WITH PHARMACODYNAMIC AND PHARMACOGENETIC EVALUATIONS PROMET 2 Ongoing PATIENTS WITH PROSTATIC HORMONE-REFRACTORY CANCER Drug: Docetaxel; Drug: Prednisone EVALUATION PFS G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST Male Adult 18-64 45 - https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-004478-29/IT Recurrent/Refractory Collaborative Group N N N Italy Urological Prostate Cancer Celecoxib PFS Phase 2 DB00567 N
2009-014772-22 Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial. chloroquine in SCLC Ongoing To determine the toxicity of adding chloroquine in escalating doses in SCLC patients - to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1 - to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2 Drug: Chloroquine Fase I, step 1 and 2: Toxicity (CTCAE 4.0) Fase II, step 1 : progression free survival Fase II, step 2: overall survival at 2 years MAASTRO Clinic All Adult 18-64 225 - https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014772-22/NL Localised/Locoregional Hospital/University/Research Institute N N N Netherlands Lung Small Cell Lung Cancer Chloroquine Safety and/or Dose; PFS; OS Phase 1/2 DB00477 N
2013-004705-59 Monocentric phase III clinical trial using citalopram (antidepressive compound fequently used in clinic) added to the standard of care (radio- combined with temozolomide chemotherapy and followed by temozolomide) for newly diagnosed glioblastoma patients compared to the standard of care published in the literature Phase III clinical trial using citalopram for glioblastoma patients Ongoing Newly diagnosed glioblastoma (primary highly malignant brain cancer) patients Under treatment Drug: citalopram could citalopram added to the standard of care increase quality of live and survival of glioblastoma patients H ocirc;pital Erasme, ULB All Adult 18-64 50 Teva - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004705-59/BE Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute N N N Belgium CNS Glioblastoma Citalopram OS; QoL Phase 3 DB01211 N
2016-000871-26 Studio di Fase II, randomizzato, in aperto, controllato di fattibilit iquest; dell iquest;impiego di doxiciclina nel tumore mammario in stadio precoce NA Ongoing Breast cancer - Stage 1-2 to or Stage 3 that is candidate for primary surgery Drug: BASSADO; Drug: DOXICICLINA ICLATO Ki67 evaluation AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA Female Adult 18-64 130 Fondazione Pisana per la Scienza - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000871-26/IT Localised/Locoregional Hospital/University/Research Institute Y N N Italy Breast Any Breast Cancer Doxycycline Biomarker Phase 2 DB04855 N
2019-004259-35 Ebastine in combination with docetaxel as a treatment for castration-resistant metastatic prostate cancer Ongoing Male patients with metastatic castration resistant prostate cancer Drug: Kestine; Drug: Ebastin Change in urine biomarkers; Bis(monoacylglycero)phosphate (BMP) Rigshospitalet Male Adult 18-64; Elderly 65+ 30 Danish Cancer Society - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004259-35/DK Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Denmark Urological Prostate Cancer Ebastine Biomarker Phase 2 DB00625 N
2016-004004-60 Prospective study of anti-inflammatory therapy post interventional radiological treatment of HCC in the cirrhotic patient. Rad-HCC Ongoing patients with HCC in the setting of cirrhosis Drug: Arcoxia; Drug: Brufen; Drug: ETORICOXIB; Drug: IBUPROFENE Serum levels of inflammatory cytokines ndash; IL-6 and HGF at baseline and day 7 (pre-op and day 7 blood draws). IRCCS ISTITUTO CLINICO HUMANITAS All Adult 18-64 48 IRCCS Istituto Clinico Humanitas - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004004-60/IT Localised/Locoregional Hospital/University/Research Institute Y N N Italy GI Liver Cancer Etoricoxib Biomarker Phase 2 DB00927 N
2018-004091-35 Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients IMPROVE-NET trial Ongoing Neuroendocrine tumors Drug: Hydralazine; Drug: Valproate The percentage of patients that will have an uptake of 68Ga-DOTATATE in the tumor equal to or above that of the liver. Erasmus University Medical Center All Adult 18-64 10 Erasmus Foundation - https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004091-35/NL Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands Endocrine Neuroendocrine Tumours Hydralazine; Valproic Acid Biomarker Phase 2 DB01611; DB00177 N
2011-004903-20 Hydroxychloroquine as an anti-autophagy and chromatin modulating drug in combination with erlotinib in non-small cell lung cancer (NSCLC) patients: a single-center single arm open-label phase II trial Hydroxychloroquine and erlotinib in NSCLC Ongoing Patients with histologically confirmed stage IV non-squamous non-small-cell lung cancer (NSCLC) bull; with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy. OR bull; who failed after at least one line of platinum based doublet chemotherapy and who are EGFR TKI na iuml;ve. The difference in metabolic activity of the tumor after one week of treatment as compared to the baseline value, measured with 18F-FDG PET using predefined PET response criteria. All Adult 18-64 136 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004903-20/NL Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands Lung Non-Small Cell Lung Cancer Hydroxychloroquine Biomarker Phase 2 DB07118 N
2011-006350-87 HydrOxychloRoqUine and Sorafenib in locally advanced or Metastatic Hepatocellular Carcinoma as First line therapy: a multi-center phase II trial HORUS Ongoing ADVANCED HEPATOCELLULAR CARCINOMA Drug: NA bull; Evaluation of clinical benefit UNIVERSITA' CAMPUS BIOMEDICO All Adult 18-64 46 universita' campus bio-medico di roma - https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-006350-87/IT Advanced/Metastatic Hospital/University/Research Institute N N N Italy GI Liver Cancer Hydroxychloroquine Other (specify) Phase 2 DB07118 N
2021-004189-37 Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer HCQHNLcancer Ongoing Patients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx), or Resectable Non-small cell lung cancer (NSCLC, only Lung Squamous Cell Carcinoma or Adenocarcinoma). Drug: Idrossiclorochina Solfato Immunohistochemical studies will be performed for known autophagic and immunological markers (CD3, CD8, CD163, p53, p62, LC3) with quantification of positivity / total cells, intensity, expression pattern. OSPEDALE SAN RAFFAELE All Adult 18-64 20 Fondo di ricerca Oncologia medica OSR - https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004189-37/IT Localised/Locoregional Hospital/University/Research Institute N N N Italy Head and Neck; Lung Any head and neck squamous cell carcinoma; Non-Small Cell Lung Cancer Hydroxychloroquine Biomarker Phase 2 DB07118 N
2021-001328-17 Histological and clinical effects of Imipramine in the treatment of patients with cancer over-expressing Fascin1. HITCLIF Ongoing Colorectal cancer and triple negative breast cancer patients (TNBC) who shown overexpression of fascin1 in the diagnostic biopsy tissue. Drug: Imipramine; Placebo Comparison of the histological traits of invasive tumour front of the surgical tumour resection specimen between the intervention group and the placebo group: 1. Fascin1 expression in tumour tissue: It will be analysed by immunohistochemistry and the application of Immunoscore. 2. Histological manifestations of the epithelial-mesenchymal transition (EMT): Tumour budding, cytoplasmic pseudo-fragments, infiltrating growth pattern and poorly differentiated nests. It will be evaluated by histological analysis. 3. Invasive histological manifestations: discontinuous extramural extension, lymphatic, venous and perineural infiltration. It will be evaluated by histological analysis. 4. Histological manifestation of the immune response: Peritumoral and intratumour lymphocyte infiltration. It will be evaluated by histological analysis. 5. EMT molecular manifestations: FSCN1, SNAIL and SLUG gene expression. It will be evaluated by NGS analysis of the primary tumour. Fundaci oacute;n para la formaci oacute;n e investigaci oacute;n sanitarias de la Regi oacute;n de Murcia All Adult 18-64 180 ISCarlos III - Contolled|Randomised|Placebo|Double blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001328-17/ES Localised/Locoregional Hospital/University/Research Institute Y N N Spain Breast; GI Breast Cancer - TNBC; Colon Cancer; Rectal Cancer Imipramine Biomarker; Other (specify) Phase 2 DB00224 N
2010-021962-31 KEES- A single arm phase II trial of the peroral regimen KEES (Ketokonazole, Etoposide, Estramustine, Sendoxan) in patients with Castration Resistant Prostate Cancer (CRPC) KEES- a phase II study in patients with CRPC Ongoing Men with castration resistant prostate cancer Drug: ketoconazole; Drug: Estramustine; Drug: Cyclophosphamide; Drug: ETOPOSIDE PSA response The proportion of patients with a PSA decline by gt; 50 , compared to baseline value, within 12 weeks after 1st day of chemotherapy. Bo Lennern auml;s Male Adult 18-64 40 - Contolled|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-021962-31/SE Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Sweden Urological Prostate Cancer Ketoconazole Biomarker Phase 2 DB01009 N
2017-004634-28 A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC) GB - no longer in EU/EEA Urothelial carcinoma (UC) Drug: isatuximab; Drug: niraparib; Drug: atezolizumab; Drug: tocilizumab; Drug: TIRAGOLUMAB 1. Objective response rate F. Hoffmann-La Roche Ltd All Adult 18-64 385 F. Hoffmann-La Roche Ltd - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004634-28/GB Advanced/Metastatic; Recurrent/Refractory Company Y N N United States Urological Urethral Cancer Tocilizumab Response rate Phase 2 DB08895 N
2007-002608-16 A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in patients with high risk for recurrence and completely resected non-small-cell lung cancer: NVALT-8B NVALT-8B Ongoing This is a randomized multicenter phase III study. Patient with a high SUVof the primary tumor prior to surgery will be randomised to four cycles of pemetrexed and cisplatin with or without nadroparin for 16 weeks in order to improve the recurrence-free survival rate in these patients. Drug: Alimta The main endpoint is recurrence-free survival UMCG All Adult 18-64 600 - Contolled|Randomised|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-002608-16/NL Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands Lung Non-Small Cell Lung Cancer Nadroparin DFS/RFS/EFS Phase 3 DB12092 N
2009-009114-40 Impact de la technique anesth eacute;sique et analg eacute;sique sur le risque de r eacute;cidive biologique de cancer de la prostate P eacute;ri-Prostate Ongoing prostate cancer Drug: Naropeine; Drug: Propofol; Drug: Morphine The primary endpoint is the biological recurrence (PSA) of prostate cancer. Hopital Foch Male Adult 18-64 320 - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-009114-40/FR Perioperative Localised/Locoregional Hospital/University/Research Institute Y N N France Urological Prostate Cancer Propofol Recurrence rate Phase 3 DB00571 N
2013-001096-20 ASSOCIATION BETWEEN PROTON-PUMP INHIBITORS (PPI) and METRONOMIC CAPECITABINE (mCAP) AS SALVAGE TREATMENT FOR PATIENTS WITH ADVANCED GASTRO-INTESTINAL TUMOURS: A RANDOMIZED PHASE II STUDY metroCAP+PPI Ongoing Patients with gastrointestinal malignancies ineligible for conventional chemotherapy Drug: Pariet; Drug: RABEPRAZOLE 1. 3-months progression-free survival (PFS).PFS is defined as the interval from the first dose of study drug to the date of the first documented disease progression or death for any reason, with censoring at the date of last contact for alive patients. 2. Safety (CTCAE v.4.03) Department of Molecular and Clinical Medicine; Sapienza University of Rome All Adult 18-64 66 Department of Molecular and Clinical Medicine; Sapienza University of Rome - Contolled|Randomised|Open|Parallel group https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001096-20/IT Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Italy GI Any GI cancer Rabeprazole Safety and/or Dose; PFS Phase 2 DB00481 N
2022-001989-36 Selective serotonin reuptake inhibition in patients with advanced gastroesophageal cancer receiving immunochemotherapy: a prospective phase II trial SIGN Ongoing gastroesophageal cancer Drug: SERTRALINE HYDROCHLORIDE The primary endpoint of this study is the rate of best responses per any timepoint during study period after administration of at least one cycle of immunochemotherapy defined as CR and PR according to RECIST 1.1 criteria Med. Univ. Wien, Klinik f. Innere Med I, Onkologie All Adult 18-64 35 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001989-36/AT Advanced/Metastatic Hospital/University/Research Institute N N N Austria GI Esophageal Cancer; Gastric Cancer Sertraline Response rate Phase 2 DB00203 N
2007-001179-13 Neo-adjuvant Simvastatin therapy in colorectal cancer Ongoing Colorectal cancer Drug: Simvastatin Levels of BMP2 and 4 and phospho-Smad1 in surgical resection specimens. levels of apoptosis and proliferation in surgical resection specimens levels of angiogenesis in surgical resection specimens Dutch Cancer Society All Adult 18-64 30 - Contolled|Randomised|Single blind https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001179-13/NL Localised/Locoregional Collaborative Group Y N N Netherlands GI Colon Cancer; Rectal Cancer Simvastatin Biomarker Phase 2 DB00877 N
2009-014452-30 Safety and efficacy of the addition of simvastatin to panitumumab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design. RASTAT-P Ongoing k-ras mutant advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan containing regimens Drug: vectibix To investigate the percentage of patients with k-ras mutant advanced or metastatic colorectal cancer free from progression (according to RECIST 1.1) and alive after 11 weeks after the first dose of panitumumab (i.e., 12.5 weeks after the scan at baseline at start of simvastatin) in the presence of simvastatin. Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum All Adult 18-64 46 - https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014452-30/NL Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands GI Colon Cancer; Rectal Cancer Simvastatin PFS Phase 2 DB00877 N
2010-018491-24 Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells Ongoing patients with malignant bone metastases Drug: simvastatin 1. Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7)and functional (IFN- , TNF- , granzyme B) changes in the circulating pool of Vy9Vd2-T cells. 2. Occurrence of a febrile response. Vrije Universiteit Medical Center All Adult 18-64 40 - Contolled|Randomised|Placebo|Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-018491-24/NL Advanced/Metastatic Hospital/University/Research Institute Y N N Netherlands Multiple cancer types Any solid tumours Simvastatin Biomarker Phase 4 DB00877 N
CTRI/2021/09/037015 Evaluating the Efficacy of Pioglitazone in combination with Neoadjuvant Chemotherapy in Patients with Extremity Skeletal High-Grade Osteosarcoma Treated with Curative Intent: A Multi-centre, Randomized Phase II Clinical Trial Not Yet Recruiting Health Condition 1: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb Intervention1: Pioglitazone will be combined with IAP chemotherapy: Tablet Pioglitazone (p.o) will be administered from day minus 5 of cycle 1 neoadjuvant chemotherapy to day plus 21 of cycle 3 neoadjuvant chemotherapy. Post-surgery, D-5 of cycle 4 up to D+21 of cycle 6 adjuvant chemotherapy
Control Intervention1: IAP chemotherapy regimen: Intravenous Ifosfamide 1.3g/m2 D1-3
Intravenous Doxorubicin 50mg/m2 D1
Intravenous Cisplatin 33mg/m2 D1-3
q3weekly
3# IAP followed by surgery followed by 3# IAP
Duration of therapy- Around 22 weeks
Rate of good responders (tumour necrosis greater than or equal to 90 Timepoint: Week 14 Cancer Institute WIA - - 50 Cancer Institute (WIA) funds Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded 15/10/2021 30/09/2021 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60852 Localised/Locoregional Hospital/University/Research Institute Y N N India Bone Sarcoma Osteosarcoma Pioglitazone Response rate Phase 2 DB04951 N
CTRI/2021/06/034467 Effect of Ketorolac of VEGF and TGF-B release in breast cancer resection surgery. Not Yet Recruiting Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Intervention1: IV ketorolac: Group 1 ?? will receive intravenous (I.V.) ketorolac Dose - 30 mg, single dose just before incision.
Control Intervention1: Group 2 - saline placebo: will receive 1 ml saline as placebo/comparator. Dose - 1 ml, single dose, both drug and saline will be provided in identical 2 ml syringe in opaque sealed envelope.
1) Evaluate the effect of single dose of perioperative ketorolac 30 mg (given before incision) on levels of marker predictive of tumour spread and metastasis ?? VEFF.
2) To evaluate the effect of Ketorolac on other markers of tumour spread i.e. TGF- , NLR and PLR (platelet lymphocyte ratio) in patients undergoing curative breast cancer resection.
Timepoint: baseline - before incision
intaroperative - after tumour resection
post-operative - 24 hours after surgery
All India Institute of Medical Sciences - - 100 All India Institute of Medical Sciences, New Delhi Interventional Study Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded 09/07/2021 30/06/2021 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48513 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Ketorolac Biomarker Not available/Missing DB00555 N
CTRI/2020/06/026240 Effects of Mebendazole to Lenvatinib (drug) in liver cancer Open to Recruitment Health Condition 1: K769- Liver disease, unspecified Intervention1: Lenvatinib and Mebendazole: Lenvatinib
Dose:8 mg if body weight is less than 60 kg and 12 mg if body weight is more than 60 kg
frequency:once a day
route of administration: oral
duration of therapy:15 months
Mebendazole
Dose:100 mg
frequency: twice a day
route of administration: oral
duration of therapy:15 months
Intervention2: Lenvatinib and Mebendazole: Lenvatinib will be given orally once a day (OD) at dose of 8 mg if body weight is 60 kg and 12 mg if body weight is 60 kg) and mebendazole will be given at dose of 100 mg orally twice a day (BD) daily
Control Intervention1: Lenvatinib with Placebo: Lenvatinib
Dose:8 mg if body weight is less than 60 kg and 12 mg if body weight is more than 60 kg
frequency:once a day
route of administration: oral
Duration of therapy: 15 months
Placebo (Tab Mecovit)
Dose:Placebo
Frequency: twice daily
route of administration: Oral
Duration of therapy:15 months
1) Overall survival in both groups
2) Death
3) Progressive disease requiring change of therapy in both groups.Timepoint: 15 months Institute of Liver and Biliary Sciences - - 170 Institute of Liver Biliary Sciences,D-1, Vasant KunjNew Delhi-110070 Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label 06/07/2020 30/06/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44747 Recurrent/Refractory Hospital/University/Research Institute Y N N India GI Liver Cancer Mebendazole Response rate; OS Not available/Missing DB00737 N
JPRN-jRCT2031190065 Investigator initiated registrational trial of Metformin for atypical endometrial hyperplasia and endometrial carcinoma Not Recruiting atypical endometrial hyperplasia and endometrial carcinoma
endometrial carcinoma;endometrial carcinoma Randomization to 3 group and administration of study drug (Metformin);Metformin The three-year disease-free survival rate Mitsuhashi Akira Female >= 18age old - <= 42age old 138 Japan Agency for Medical Research and Development Interventional Study randomized controlled trial, open(masking not used), dose comparison control, parallel assignment, treatment purpose 25/09/2019 30/07/2019 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCT2031190065 Localised/Locoregional Hospital/University/Research Institute Y Y N Japan Gynaecological Endometrial Cancer Metformin DFS/RFS/EFS Not available/Missing DB00703 N
JPRN-UMIN000001815 Prospective randomized controlled study for preventive effect of menatetrenone against the recurrence of hepatocellular carcinoma after hepatectomy Complete: follow-up continuing Hepatocellular carcinoma The study was designed to test the hypothesis that MNT would reduce the incidence of recurrence of HCC in patients underwent initial hepatectomy. The patients stated to take 15 mg of menatetrenone, 3 times a day, orally everyday.
Control group does not take any drugs. Disease-free survival period after hepatectomy Second Department of Surgery Dokkyo Medical University All Not applicable - Not applicable 84 None. Interventional Study Parallel Randomized 11/01/2005 30/03/2009 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001929 Localised/Locoregional Hospital/University/Research Institute Y N N Japan GI Liver Cancer Menatetrenone DFS/RFS/EFS Phase 2 DB01103 N
CTRI/2021/09/036956 Pioglitazone in Patients with Recurrent/ Refractory Inoperable High-Grade Osteosarcoma Not Yet Recruiting Health Condition 1: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb Intervention1: Pioglitazone: Dose of tablet Pioglitazone (per oral):
Age: 14-17 years- 15 mg twice daily
18 years and above- 15 mg thrice a day
If there is a response, pioglitazone can be continued at the same dose until disease progression, treatment toxicities or patient refusal.
Control Intervention1: Not applicable: Not applicable
Clinical and radiological response assessmentTimepoint: ? For every patient recruited in the study, response will be assessed at 3-months (Thereafter, at 3-monthly intervals until disease progression/ treatment discontinuation or death.) Cancer Institute WIA - - 10 None Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 15/10/2021 29/09/2021 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60703 Recurrent/Refractory Hospital/University/Research Institute N N N India Bone Sarcoma Osteosarcoma Pioglitazone PFS Not available/Missing DB04951 N
JPRN-jRCTs051190076 Neo-adjuvant combination chemotherapy of Tranilast in esophageal carcinoma Recruiting advanced esophageal squamous cell carcinoma
Esophageal Squamous Cell Carcinoma;Esophageal Squamous Cell Carcinoma The additional use of tranilast to conventional neoadjuvant chemotherapy (5-FU/CDDP) for advanced esophageal squamous cell carcinoma patients Pathological therapeutic effect Shiozaki Atsushi All >= 20age old - <= 74age old 59 Interventional Study single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose 14/11/2019 29/11/2019 27/05/2024 https://jrct.niph.go.jp/latest-detail/jRCTs051190076 Localised/Locoregional Hospital/University/Research Institute N N N Japan GI Esophageal Cancer Tranilast Response rate Phase 1/2 DB00752 N
DRKS00014054 Pancreatic resection with perioperative off-Label study of Propranolol and Etodolac - A Phase II randomized Trial Other ;C25.0 - Malignant neoplasm: Head of pancreas Intervention 1: Propranolol 2x20 mg/day, p. o.: 10 days before surgery; Propranolol 2x40 mg/day, p.o.: day of surgical intervention and 1st day until 7th day after operation; Propranolol 2x20 mg/day, p. o.: 8th until 14th day postoperative.
Etodolac 2x400 mg/day p. o., 10 days before surgery until 14th day postoperative Intervention 2: Placebo with similar shape compared to Propranolol 2x1/day, p. o.: 10 days before surgical intervention; 2x2/day p.o.: Day of Operation, and 1st to 7th day postoperative;
2x1/day, p. o.: 8th to 14th day postoperative.
Placebo with similar shape compared to Etodolac 2x1/day p. o., 10 days before operation until 14th day postoperative. Safety endpoints:
€ Rates of serious adverse events and serious adverse drug re-actions
€ Mortality at 30 and 90 days postoperatively
€ Pancreas-associated morbidity (Pancreatic fistula, delayed gas-tric emptying, postoperative pancreatic hemorrhage, biliary leakage, fluid collection/abscess)
Feasibility endpoints:
€ Adherence to study medication
€ Completion of adjuvant chemotherapy Universit tsklinikum Heidelberg All 18 Years - no maximum age 100 Het Anti-Kankerfonds;Klinik f r Allgemein-, Viszeral-und TransplantationschirurgieUniversit tsklinikum Heidelberg Interventional Study Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist, caregiver, assessor). Control: Placebo. Assignment: Parallel. Study design purpose: Treatment; 2018-000415-25;AFmo-385/2018 23/01/2019 29/08/2018 14/11/2022 http://www.drks.de/DRKS00014054 Localised/Locoregional Hospital/University/Research Institute Y N N Germany GI Pancreatic Cancer Etodolac; Propranolol Safety and/or Dose Phase 2 DB01628; DB00165 N
CTRI/2021/12/038966 Effect of anaesthetic technique on the recurrence of breast cancer after surgery. Not Yet Recruiting Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Intervention1: Total intravenous anaesthesia combined with fascial plane blocks: TIVA with propofol infusion combined with PEC1 and SAM block
inj fentanyl 1 mcg/kg intravenous.
inj propofol 25-100 mcg/kg/min intravenous till end of surgery.
PEC1 block USG guided with 10 ml of inj bupivacaine 0.5 in fascial plane
SAM block with 20 ml of 0.5 inj bupivacaine in fascial plane
Control Intervention1: inhalational anaesthesia: inj fentanyl 1-2mcg/kg intravenous
Sevoflurane based inhalation anaesthesia (0-2 ) to maintain MAC of 1
1) Recurrence of breast cancer (loco-regional or distant)
2) Recurrence free survival
Timepoint: two years
nil - - 180 Homi Bhabha Cancer Hospital and Research Centre, Punjab Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded 31/12/2021 28/12/2021 21/02/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60001 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Propofol DFS/RFS/EFS Not available/Missing DB00571 N
CTRI/2018/11/016459 Role of lipid lowering drug in the treatment of rectal cancers Not Yet Recruiting Health Condition 1: K628- Other specified diseases of anus and rectum Intervention1: Rosuvastatin in addition to Neo-adjuvant Chemoradiotherapy: Rosuvastatin is a 3rd generation statin has high potency and efficacy It owes remarkable potency and efficacy due to its fluorinated phenyl group and hydrophilic methane sulphonamide group in addition to the common dihydroxyheptenoic acid side chain. Its unique chemical structure enables multiple and strong binding with HMG-CoA reductase enzyme.
In addition :
Radiotherapy: 45-50Gy of NACTRT would be given to pelvis for period of 5-6weeks.
-Concurrent chemotherapy: Tablet Capecitabine 825 mg/m2 given orally twice daily from D1-D35 along with radiotherapy
Control Intervention1: Neo adjuvant Chemoradiotherapy: Radiotherapy: 45-50Gy of NACTRT would be given to pelvis for period of 5-6weeks.
-Concurrent chemotherapy: Tablet Capecitabine 825 mg/m2 given orally twice daily from D1-D35 along with radiotherapy
To determine the impact of Rosuvastatin in improving pCR in patients with localized rectal cancer undergoing neoadjuvant chemoradiotherapy.Timepoint: Rosuvastatin week 2 and week 4 visit and at week 6 Tata Memorial Hospital - - 316 Intramural funding, TMC, Mumbai Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label 01/12/2018 28/11/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29100 Localised/Locoregional Hospital/University/Research Institute Y N N India GI Rectal Cancer Rosuvastatin Response rate Phase 2/3 DB10276 N
CTRI/2020/09/028095 Increasing the local pH during chemoembolization for hepatocellular carcinoma Not Yet Recruiting Health Condition 1: C220- Liver cell carcinomaHealth Condition 2: C00-D49- Neoplasms Intervention1: sodium bicarbonate: Before doing standard TACE, In each tumor feeding artery, about 25 ??ml bicarbonate would be injected into tumor feeding artery. Maximum of 3 arteries will be treated per session (i,e maximum dose of 75 ml of 5 sodium bicarbonate will used per session)
Intervention2: Standard transarterial chemoembolization with sodium bicarbonate: Before standard TACE, In each tumor feeding artery, about 25 ??ml bicarbonate would be injected into tumor feeding artery. Maximum of 3 arteries will be treated per session (i,e maximum dose of 75 ml of 5 sodium bicarbonate will used per session
Intervention3: NA: NA
Control Intervention1: Not applicable: Not applicable
-Safety of adding bicarbonate along with TACETimepoint: 1 MONTH, 3 MONTH, 6 MONTH TATA MEDICAL CENTER - - 10 tata medical center Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 29/09/2020 28/09/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46968 Localised/Locoregional Hospital/University/Research Institute N N N India GI Liver Cancer Sodium Bicarbonate Safety and/or Dose Phase 1 DB00421 N
CTRI/2016/09/007315 The study of oral chemotherapy in locally advanced head and neck cancer post radical chemoradiation Not Yet Recruiting Health Condition 1: null- Locally advanced head and neck cancers Intervention1: Methotrexate and Celecoxib: Tab Methotrexate 15 mg/m2 weekly PO and Capsule Celecoxib 200 mg PO Twice Daily for 18 months
Control Intervention1: Observation: Patient will be followed up at regular interval clinically.
Overall SurvivalTimepoint: 3 years Tata Memorial Hospital - - 1038 Tata Memorial Hospital Dr E Borges Marg Parel East Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label 01/11/2016 28/09/2016 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16278 Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Any head and neck squamous cell carcinoma Celecoxib OS Phase 3 DB00567 N
JPRN-UMIN000014689 Study about the efficacy of metformin to immune function in cancer patients. Complete: follow-up continuing cancer and sarcoma Administering metformin. Ability to produce cytokines (IL-2, TNF alpha, IFN gamma) and differentiation (memory, regulatory etc.) in peripheral blood T cells. Okayama University Hospital All 20years-old - Not applicable 30 Okayama University Hospital Interventional Study Single arm Non-randomized 16/07/2014 28/07/2014 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016406 Any/All Stages Hospital/University/Research Institute N N N Japan Multiple cancer types Any solid tumours Metformin Biomarker Phase 2 DB00703 N
ACTRN12619000310167 Vitamin C for endometrial cancer Recruiting Endometrial Cancer;
Endometrial Cancer;Cancer - Womb (Uterine or endometrial cancer) This study comprises a surgical window-style study design with an intervention administered between diagnosis and planned surgical resection.
1. Following diagnosis of endometrial cancer and informed consent, prior to planned elective surgery, tumour tissue will be collected by pipelle biopsy. This biopsy is in addition to standard care, and it will be taken in an outpatient setting. The pipelle biopsy is a commonly performed outpatient procedure and in fact many patients will have experienced this as their diagnostic procedure. The procedure involves insertion of a vaginal speculum and the introduction of a fine plastic tube into the uterus. Material from within the uterine cavity is sucked into the tube by applying negative pressure. For the purpose of the study the biopsy will be performed by the named clinical investigators who are highly experienced at this procedure, and the patients will have a good understanding of the required procedure. Appropriate oral and local analgesia will be given in consultation with the patient. The procedure will be performed in a safe clinical environment with appropriate analgesia and a nurse assistant. Adverse events associated with the pipelle biopsy will be recorded.
2. Patients usually proceed to surgery approximately two € four weeks from the initial diagnostic biopsy. Within this time frame, Vitamin C administration will be co-ordinated to start five days before the planned surgical removal of the endometrial tumour.
2. Vitamin C will be administered by intravenous infusion daily for four days prior to surgery, beginning with a dose of 25 g, then 1g/kg capped at a maximum of 75 g.
3. Blood samples will be collected at the time of pipelle biopsy, and then daily for four days prior to and after high dose vitamin 1.Measurement of ascorbate levels in endometrial tumour tissue in biopsy samples and post-ascorbate treatment surgical specimens.
[Biopsy samples taken at recruitment. Vitamin C infusions given for 4 consecutive days immediately prior to surgery (day 5). Tumour tissue obtained post-surgery.];2.Determination of the composite outcome of the association between ascorbate and the upregulation of the tumour hypoxic pathway, as assessed by the measurement of the HIF-1, VEGF, BNIP3, and CA-IX proteins and tumour ascorbate. [Biopsy samples taken at recruitment. Vitamin C infusions given for 4 consecutive days immediately prior to surgery (day 5). Tumour tissue obtained post-surgery.] University of Otago Female 18 Years - 75 Years 21 University of Otago Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy; Nil known. 22/08/2019 28/02/2019 26/09/2022 https://anzctr.org.au/ACTRN12619000310167.aspx Localised/Locoregional Hospital/University/Research Institute Y N N New Zealand Gynaecological Endometrial Cancer Ascorbic acid Biomarker Other DB00335 N
CTRI/2017/11/010651 standard chemotherapy plus aspirin vs standard chemotherapy alone in locally advanced and metastatic stomach cancer Closed to Recruitment of Participants Health Condition 1: null- advanced stomach cancer patients able to take tablets orally with normal organ function and a good performance statusHealth Condition 2: C169- Malignant neoplasm of stomach, unspecified Intervention1: EOX plus Aspirin: patients of locally advanced and metastatic gastric cancer fulfilling the inclusion criteria
Control Intervention1: EOX: patients of locally advanced and metastatic gastric cancer fulfilling the inclusion criteria
response rate PFS OS toxicitiesTimepoint: OS is defined as the time from entry into the clinical trial until death as a result of any cause.PFS is the time from entry into the study until progression or death as a result of any cause.recruitment started from March 2017 and will stop in June 2018.Response assessment will be done every 3 to 4 chemotherapy cycles by imaging and at every cycle clinically. After completion of chemotherapy imaging will be done every 3 months.based on the RECIST 1.1 CR/PR/SD/PD and PFS will be defined. Jawaharlal Institute of Post graduate Medical education and Research - - 110 Jawaharlal Institute of Post graduate Medical Education and Research Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded 01/03/2017 27/11/2017 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20908 Advanced/Metastatic Hospital/University/Research Institute Y N N India GI Gastric Cancer Acetylsalicylic Acid Response rate; PFS; OS Phase 2/3 DB01048 N
CTRI/2020/02/023616 To study the combination of oral (Metronomic)chemotherapy along with Intravenous chemotherapy (Paclitaxel) in advanced stage head and neck cancer patients Not Yet Recruiting Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Intervention1: Paclitaxel and carboplatin with Oral Metronomic Chemotherapy: Patients on arm B will receive initially Paclitaxel (175mg/m2) plus Carboplatin (AUC 5) on day 1 in 3 weekly cycles. In addition they will receive a fixed dose of celecoxib 200 mg PO BD, erlotinib 150 mg PO OD and methotrexate 9 mg/m2 weekly.
Intervention2: Paclitaxel plus carboplatin followed by maintenance OMCT: Patients on arm C will receive initially Paclitaxel (175mg/m2) plus Carboplatin (AUC 5) on day 1 in 3 weekly cycles for 6 cycles followed by a fixed dose of celecoxib 200 mg PO BD, erlotinib 100 mg PO OD and methotrexate 9 mg/m2 weekly. The metronomic will start 2-4 weeks post completion of 6 cycles of Paclitaxel and Carboplatin.
Control Intervention1: Paclitaxel plus Carboplatin (Chemotherapy): Patients on arm A will receive Intravenous Paclitaxel (175mg/m2) plus Carboplatin (AUC5) on day 1 in 3 weekly cycles.
Phase 2: Progression Free survival
Phase 3: Overall SurvivalTimepoint: Phase 2: The response would be monitored in accordance with institutional standards. That is after first 3 cycle and every 2 months therafter.
Phase 3: After completion of study patients will be followed up every 2 months for overall survival. Tata Memorial Hospital - - 621 Tata Memorial HospitalDr E Borges road,Parel Mumbai 400012 Interventional Study Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable TMH project Number-3351;Version 2.1 Dated 10 December 2019 01/04/2020 27/02/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=39789 Advanced/Metastatic Hospital/University/Research Institute Y Y N India Head and Neck Any head and neck cancer Celecoxib PFS; OS Phase 2/3 DB00567 N
JPRN-UMIN000025398 A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer Recruiting Unresectable pancreatic cancer itraconazole 400 mg po day -2 +3 nabpaclitaxel 125 mg/m2 day 1 gemcitabine 1000 mgm2 day 1 L-OHP 85 mg/m2 day 1 q14d Response rate, operability Meiwa Hospital All 20years-old - 80years-old 28 Meiwa Hospital Interventional Study Single arm Non-randomized 06/01/2016 27/12/2016 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029075 Advanced/Metastatic Hospital/University/Research Institute N N N Japan GI Pancreatic Cancer Itraconazole Response rate; Other (specify) Phase 2 DB00602 N
NL9017 Blood-borne Assessment of Stromal activation in esophageAL adenocarcinoma to guide tocilizumab Therapy: a randomized phase II proof-of-concept study Pending Esophageal adenocarcinoma tocilizumab The primary objective of this study is to demonstrate that stroma-targeting by tocilizumab in esophageal adenocarcinoma patients with highly activated stroma increases efficacy of chemoradiotherapy measured by pathological response according to the Mandard criteria. Patients will be grouped for ADAM12, a non-invasive blood-borne marker of stromal activation. Investigator-initiated, sponsored by Oncode Institute - - 48 Oncode Institute Interventional Study Randomized controlled trial, Open (masking not used), N/A , unknown, Parallel NL9017;METC AMC : METC 2020_187 16/11/2020 27/10/2020 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/20876 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands GI Esophageal Cancer Tocilizumab Other (specify) Phase 2 DB08895 N
ISRCTN16867955 A randomised phase 3 trial evaluating the role of finasteride in increasing compliance with active surveillance, in men with a new diagnosis of low and intermediate risk prostate cancer, when compared with usual care. Ongoing Men with a new diagnosis of low- and intermediate-risk prostate cancer
Cancer
Malignant neoplasm of prostate FINESSE is a multicentre, open label, prospective, two-armed randomised controlled CTIMP, to test the superiority of finasteride and active surveillance over- active surveillance alone, in men with newly diagnosed low/intermediate risk localised prostate cancer.
We will randomise (1:1), 550 patients to Active Surveillance with or without once daily finasteride, (5mg). Patients will receive finasteride for 2 years and will be followed up for an average of 4 years. Active surveillance will include PSA, re-biopsy and mpMRI as per usual NHS care. The primary outcome is adherence with Active Surveillance in both arms.
€ There are no placebo treatments for the following reasons: The PSA levels in men treated with finasteride will almost halve. Since it is necessary to monitor PSA (for AS) this would unblind both arms unless clinicians and patients were blinded to the PSA results.
€ Blinding PSA data would be impractical, since men may actively seek PSA tests outside the study.
€ It is ethical that control patients experiencing any side effects, e.g., erectile dysfunction, ejaculatory problems, or a rash, know they are independent of the treatment.
€ Participants unaware they are taking finasteride may opt for radical treatment earlier. This is a pragmatic trial designed to see whether knowing that they are being treated and that the treatment is having a positive impact on PSA levels would reassure men and enable them to continue with active surveillance for longer, rather than seeking radical treatment even though their disease may not have progressed.
€ The prohibitive costs logistics associated with placebo-controlled trials
Randomisation:
A web-based randomisation system will be designed, using the bespoke KCTU randomisation system. The randomisation syst Adherence with Active Surveillance at 2 and 5 years after diagnosis. Adherence is defined as the absence of a change in treatment to radical therapy or treatment of advanced disease measured using patient records. Sheffield Teaching Hospitals NHS Foundation Trust Male - 550 Yorkshire Cancer Research Interventional Study Interventional randomized controlled trial (Treatment) 2021-004004-17;Nil known;IRAS 1004290, STH21032 15/08/2022 27/08/2021 29/04/2024 https://www.isrctn.com/ISRCTN16867955 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom Urological Prostate Cancer Finasteride Other (specify) Phase 3 DB08868 N
JPRN-UMIN000028405 Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer. Complete: follow-up continuing lt;Stage 1 gt; Advanced or recurrent solid cancer lt;Stage 2 gt; Advanced or recurrent non-small cell lung cancer, advanced or recurrent thymic epithelial tumor and advanced or recurrent pancreatic cancer Continue to administer Nivolumab and Metformin to a patient until the patient correspond to the withdrawal criteria for individual subjects 1) Safety - Maximum tolerant dose (MTD):from first administration to last administration (stage 1 only) - Dose limiting toxicity (DLT): for 4 weeks from first administration (stage 1 only) - Adverse event:from first administration to 30 days after last administration 2) Pharmacokinetics property of metformin: from cycle 1 day8 to a day before cycle 2 day 1 Okayama University Hospital Center for Innovative Clinical Medicine All 20years-old - Not applicable 39 Ono Pharmaceutical Co.Ltd. Interventional Study Single arm Non-randomized 25/08/2017 27/07/2017 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031915 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Multiple cancer types Any solid tumours Metformin Safety and/or Dose Phase 1 DB00703 N
CTRI/2018/06/014620 Safety and effectiveness study of ormeloxifene in breast cancer patients. Open to Recruitment Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Tamoxifen resistant metastatic/recurrent breast cancer Intervention1: Ormeloxifene 120 mg per day: Ormeloxifene 120 mg per day in tamoxifen resistant metastatic/recurrent breast cancer patients.
? Overall response rates (ORR) will be calculated as the proportion of patients who achieved a tumor response of partial response (PR) or complete response (CR) as per RECIST 1.1 guidelines. Data will be as number of patients ( of patients) who achieved a tumor response of partial response (PR) or complete response (CR).Timepoint: 60 ? 2 Days, 120 ? 2 Days HLL Lifecare Limited - - 56 HLL Lifecare Limited, (A Government of India Enterprises)Corporate R D Centre,Akkulum, Sreekariyam, P.OThiruvananthapuram-695017,Kerala, India Interventional Study Single Arm Study
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable ECTS/16/002, Ver 02, 08 Nov 2017, Amendment 001, 12 Oct 2020 16/07/2018 26/06/2018 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23948 Advanced/Metastatic; Recurrent/Refractory Company N N N India Breast Breast - Other Ormeloxifene Response rate Phase 2 DB00198 N
CTRI/2016/04/006872 The study of small dose chemotherapy after surgery not fit for radiotherapy in recurrent head and neck cancers patients. Not Yet Recruiting Health Condition 1: null- recurrent head and neck cancers patients post R0 salvage surgical resection who are ineligible for re-irradiation. Intervention1: Methotrexate and Celecoxib: Oral methotrexate tablet 15mg/m2 will be administered weekly i.e on D1,D8, D15 D22 of every 28 day cycle. Capsule celecoxib will be self administered twice daily in a dose of 200 mg BD continuously from D1-D28.
Control Intervention1: Best Supportive Care: Best supportive care will be offered when appropriate and clinically indicated
Overall survivalTimepoint: Overall survival : at 24 months Tata Memorial Hospital - - 400 Tata Memorial HospitalDr E Borges Road Parel Mumbai 400012 Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label 16/05/2016 26/04/2016 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13989 Recurrent/Refractory Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Celecoxib OS Phase 2/3 DB00567 N
ACTRN12621001458820 Safety and Tolerability of Hydroxychloroquine in Participants with Multiple Myeloma and Partial Response or Less to Carfilzomib Not yet recruiting Cancer;Myeloma;
Cancer
Myeloma;Cancer - Myeloma All study participants will initially receive 2 cycles of once-weekly intravenous Carfilzomib and oral Dexamethasone as per the standard of care. During the rest period of Cycle 2, disease response assessment will be performed according to the International Myeloma Working Group (IMWG) Criteria for Response Assessment. Each cycle is 28 days.
Participants who achieve a very good partial response (VGPR) or above will continue receiving once-weekly Carfilzomib and Dexamethasone (without Hydroxychloroquine), as per the standard of care and at the discretion of the treating physician. Participants who achieve a partial response (PR) or below will undergo additional assessments before beginning treatment with oral Hydroxychloroquine and continued once-weekly Carfilzomib and Dexamethasone. The dose of Hydroxychloroquine that a participant will receive is dependent on the stage of dose-escalation: Level -1, 200 mg every other day; level 1 (starting dose) 200 mg once daily; level 2, 200 mg twice daily; level 3, 200 mg three times daily; level 4, 400 mg twice daily. The duration of combined treatment will be a maximum of 10 cycles.
Carfilzomib 20 mg/m2 will be given as the starting dose on Cycle 1 Day 1, followed by escalation to 70 mg/m2 for all subsequent doses, if tolerated. Participants will continue to receive Carfilzomib at 70 mg/m2 until treatment discontinuation.
Strategies to monitor adherence include checking patient records, medication diary and counting hydroxychloroquine tablets at the end of each cycle. Incidence and severity of adverse events.
The tool to measure severity of adverse events is the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. [Once every cycle till 12 months from the end of treatment. ];Disease response as per the International Myeloma Working Group criteria.[Disease response is measured based on laboratory markers collected just prior to the administration of the next cycle. It is measured every cycle or once a month till 12 months from the end of treatment.];Change in heart function in participants on Hydroxychloroquine and Carfilzomib[ECG is performed at the start of each cycle of combined Hydroxychloroquine and Carfilzomib.
Echocardiogram is performed at cycle 2, 4 and 7 in participants on combined Hydroxychloroquine and Carfilzomib.] South Western Sydney Local Health District All 19 Years - No limit 36 South Western Sydney Local Health District Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety; 01/06/2022 26/10/2021 05/09/2022 https://anzctr.org.au/ACTRN12621001458820.aspx Other (specify) Hospital/University/Research Institute N N N Australia Other Haem-onc Multiple Myeloma Hydroxychloroquine Safety and/or Dose; Biomarker Phase 1 DB07118 N
NTR3632 Development and clinical activity of low dose metronomic chemotherapy with oral paclitaxel. Recruiting Cancer, oral, paclitaxel, low dose metronomic, phase 1, kanker, oraal, laaggedoseerd, metronoom, fase 1 Patients with histological or cytological proof of cancer (excluding patients with secondary breast cancer metastasis with only lung metastases and primary brain tumors) for whom no standard treatment options are available, but who might benefit from treatment with paclitaxel and who are in good clinical condition will be eligible. Three patients will be assigned to each dose level. On a predefined day the patient will start receiving oral paclitaxel BID, dosed according to the escalation schedule and 100 mg ritonavir. This regime will be continued until progressive disease or until adverse events, which require dose modifications or discontinuation of therapy, are observed.
This is a dose escalation study. The starting dose was bi-daily 2.5 mg paclitaxel absolute (as ModraPac001 capsules) and 100 mg ritonavir (as tablets) BID with at least 7, but not more than 12 hours dose interval (intakes around the same time). To determine the safety and feasibility of LDM bi-daily oral paclitaxel (as ModraPac001 capsules) in combination with boosting agent ritonavir. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital - - 40 Interventional Study N/A: single arm study, N/A , unknown, Parallel NL3339;NTR3632;NKI-AVL : N10MOP;ISRCTN wordt niet meer aangevraagd. 09/05/2011 26/09/2012 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/21795 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Netherlands Leukemia; Lymphoma Any solid tumours; Any leukemias; Any lymphoma Ritonavir Safety and/or Dose; Other (specify) Phase 1 DB01656 N
ACTRN12617001087347 A clinical trial comparing Simvastatin to placebo, in addition to standard chemotherapy and radiotherapy, in preoperative treatment for patients with rectal cancer. Recruiting Rectal Cancer;
Rectal Cancer;Cancer - Bowel - Back passage (rectum) or large bowel (colon) The statin chosen for this trial, simvastatin (SIM), is a well-known and widely available 3-hydroxy-3-methyl-glutaryl-coenzyme (HMG-CoA) reductase inhibitor commonly used in the treatment of hypercholesterolaemia and ischaemic heart disease. Simvastatin or placebo is the trial intervention.
Simvastatin will be given as a 40 mg capsule taken daily for 90 days, starting 1 week prior to first radiation dose for standard Preoperative chemoradiation (pCRT).
capsules, Simvastatin will be encapsulated in Swedish orange size DB AA € capsules, filled with microcrystalline cellulose powder. Patients will be asked to return unused drug and empty drug containers at the Week 13 visit (6 weeks post-pCRT). The number of capsules remaining will be counted by trial research staff and recorded to confirm adherence. To compare rates of favourable (grades 1-2) MRI-based tumour regression grading (by central review) following preoperative chemoradiation (pCRT)with Simvastatin or placebo, considering MRI-based tumour regression grading in 4 ordered categories: 1, 2, 3, 4-5.[Based on MRI 6 € 8 weeks after preoperative chemoradiation, an analysis of inter-observer agreement on mrTRG between site radiologists and a central
radiologist will be repeated on all remaining patients at the conclusion of the trial or prior to any publication of results.] The Australasian Gastro-Intestinal Trials Group (AGITG) All 18 Years - No limit 222 Cancer Council NSW;Cancer Australia Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy; AG0115R/CTC0138 26/04/2018 26/07/2017 18/07/2023 https://anzctr.org.au/ACTRN12617001087347.aspx Localised/Locoregional Collaborative Group Y N N Australia GI Rectal Cancer Simvastatin Response rate Phase 2 DB00877 N
CTRI/2012/07/002828 Effect of Celecoxib and Erlotinib in Oral Cancers Closed to Recruitment of Participants Health Condition 1: null- Oral cancer Intervention1: 1.Arm :Celecoxib
2.Arm 2:Erlotinib
3.Arm 3:Celecoxib and Erlotinib
: 1.Arm 1: Celecoxib 200mg twice daily
2.Arm 2:Erlotinib 150mg alone
3.Arm 3:Celcoxib 200mg twice daily+Erlotinib 150mg daily
Patients in the drug treatment will receive the prescribed drug for 21 days before the tumor being surgically resected.
Intervention2: Celecoxib: Arm 1: Celecoxib 200mg twice daily. Surgery after 21 days.
Intervention3: Erlotinib: Erlotinib 150mg daily for 21 days arm 2
Intervention4: Celecoxib 200mg +
Erlotinib 150mg: Celecoxib 200 mg twice daily + Erlotinib 150 mg once daily for 21 days. Surgery after completion of 21 days treatment.
Control Intervention1: No drugs: Patients will be operated 3 weeks after recruitment
Control Intervention2: No drugs: Patients will be operated 21 days after recruitment
oTo study the effect of COX-2 inhibitor Celecoxib and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular markers of apoptosis and angiogenesis. Markers to be studied include VEGF and p53.Timepoint: Clinical response assessment after 21days of drug treatment.
Marker analysis after recruitment of all (64) patients.
Followup for 36 months.
Survival analysis after 36 months. Tata Memorial Centre - - 64 Tata Memorial Centre Interventional Study Randomized, Parallel Group, Multiple Arm Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label CT-Drugs/206/2011;TMC IRB project no 830 01/08/2012 25/07/2012 13/11/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4766 Localised/Locoregional Hospital/University/Research Institute N Y N India Head and Neck Oropharyngeal Cancer Celecoxib Response rate; Biomarker Phase 2 DB00567 N
CTRI/2019/02/017815 A study of Metformin plus chemotherapy in Lung cancer Not Yet Recruiting Health Condition 1: C34- Malignant neoplasm of bronchus andlung Intervention1: Metformin: Metformin, orally with food, administered continuously, beginning with chemotherapy. Metformin treatment will follow a dose escalation scheme, starting with a dose of 500 mg twice a day (day 0). At day 8, a metformin dose increase is planned, with the first daily dose of 1000 mg and 500 mg as the second dose. At the start of 2nd cycle metformin will be increased to 1000 mg twice a day
Control Intervention1: Not Applicable: Not Applicable
To evaluate if addition of metformin with pemetrexed carboplatin in patients with previously untreated advanced or metastatic NSCLC can increase 6 month PFS rate from 50 to 65 Timepoint: 6 months Department of Medical Oncology - - 100 Department of Medical OncologyAll India Institute of Medical Sciences, New Delhi Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 01/03/2019 25/02/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31537 Advanced/Metastatic Hospital/University/Research Institute N N N India Lung Non-Small Cell Lung Cancer Metformin PFS Phase 2 DB00703 N
NTR1456 Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx Pending CarcinomaOropharynxRadiotherapy Additional adminsitration of cidofovir during the six weeks of radiotherapeutical treatment. Extra biopsy after 96 hours of the first cidofovir administration, if feasible.
Monitoring urine and serum for renal, liver function, full blood count weekly and monitoring vital parameters weekly during administration. 1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy. initiator = sponsor - - 12 fund = initiator Interventional Study N/A , unknown, Other NL1396;NTR1456;NL19517.068.07;ISRCTN wordt niet meer aangevraagd 03/01/2009 25/09/2008 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/27994 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands Head and Neck Oropharyngeal Cancer Cidofovir Safety and/or Dose Phase 1 DB09232 N
CTRI/2018/01/011542 Mebendazole in brain tumor Open to Recruitment Health Condition 1: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 2: null- Recurrent high grade glioma Intervention1: Arm C2: Temozolomide + Mebendazole;
Temozolomide : 150-200 mg/m2 D1-D5, PO for 28 day cycle.
Mebendazole : 100-1600 mg TDS, daily , PO for 28 days.
The regimen will continue till progression of disease
Control Intervention1: Arm B2: CCNU + Mebendazole;
CCNU : 110 mg/m2 D1 PO for 42 day cycle.
Mebendazole : 100-1600 mg TDS, daily , PO for 28 days.
The regimen will continue till progression of disease
Phase 1 : MTD determination of Mebendazole
Phase 2 : 9 month overall survival
Timepoint: 9 Months
Tata Memorial Hospital - - 195 Brain Tumor FoundationTata Memorial Hospital,Dr E Borges Road, Parel, Mumbai 400012 Interventional Study Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label 12/02/2018 24/01/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21603 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India CNS Glioma Mebendazole Safety and/or Dose; OS Phase 1/2 DB00737 N
NTR988 High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study. Suspended multiple myeloma Treatment of relapsed/ refractory multiple myeloma patients with high dose statins, combined with chemotherapy. We treat multiple myeloma patients with 15 mg/kg simvastatin Day 0-7 followed by VAD day 7-11 (Vincristin, adriamycin, dexamethasone)chemotherapy in a scheme as used in HOVON trials (eg HOVON 65). On day 29 a new cycle is started. Patients are treated with 3 cycles. An additional cycle can be given in case of response (MR, PR ,CR).
In case of progressive disease during treatment, the therapy is ended. The primary endpoint is response as defined by the EBMT criteria. This group of extensively pre-treated patients are multiresistent and we defined -based in literature- a respose of 10- 30 as reasonable. The study is conducted on the department of hematology in het University Medical Center Utrecht. The study is approved by the Medical Ethical Board of this same hospital. - - 12 Dutch Cancer SocietyInternational myeloma foundation Interventional Study N/A , unknown, Other NL962;NTR988; : 04/239;ISRCTN85384018 05/03/2005 24/05/2007 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/20029 Recurrent/Refractory Collaborative Group N N N Netherlands Other Haem-onc Multiple Myeloma Simvastatin Response rate Phase 2 DB00877 N
PACTR201602001488346 Effect of sodium bicarbonate 8.4 on bronchial carcinoma Recruiting
Cancer
Respiratory
Bronchogenic Carcinoma;Cancer;Respiratory;Bronchogenic Carcinoma ;Intra-tumoral injection of sodium bicarbonate 8.4 via fiberoptic bronchoscopy;Inhalation of nebulized sodium bicarbonate 8.4 ;image guided intra-tumoral injection of sodium bicarbonate 8.4 Cathepsin B level and expression ;histopathological changes;electron microscopic changes;clinical presentation;tumor volume on radiology Mohammad Khairy El Badrawy All 18 Year(s) - 70 Year(s) 90 no funding source Interventional Study Parallel: different groups receive different interventions at same time during study,Non-randomised 01/02/2016 24/02/2016 29/05/2023 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1488 Localised/Locoregional Hospital/University/Research Institute N Y N Egypt Lung Non-Small Cell Lung Cancer; Small Cell Lung Cancer Sodium Bicarbonate Response rate; Biomarker Other DB00421 N
CTRI/2018/03/012810 Advantages of adding Metformin to Chemotherapy in Breast Cancer Patients Open to Recruitment Health Condition 1: null- Carcinoma Breast Intervention1: Intervention- Metformin with Neoadjuvant Chemotherapy
: Intervention-Study group will receive metformin along with neo adjuvant chemotherapy.Participants in Study group will be started with Metformin from day 1 of neo adjuvant chemotherapy up to the 7th cycle of NeoAdjuvant . Three cycles of FEC and four cycles of Docetaxel will be given as a standard neo adjuvant therapy in this study. 500 mg Metfromin for 2 weeks followed by 500 mg metfromin BD for weeks then 500 mg TDS till last chemotherapy will be added in study group
Control Intervention1: METFORMIN: Study Group-Chemotherapy 7 cycles plus Metformin 500 OD for 2 weeks followed by 500 mg for 2 weeks followed by 00 mg TDS till the 7th cycle of Chemotherapy
control- 7 cycles of chemotherapy alone. 3 cycles of FEC and 4 cycles of Docetaxel
Control Intervention2: Neoadjuvant Chemotherapy: Participants will receive only NEoadjuvant Chemotherapy.
3 cycles of FEC and 4 cycles of Docetaxel
To assess the effect of adding metformin to neo-adjuvant chemotherapy in Breast Cancer patientsTimepoint: 7 months after starting NACT JIPMER - - 100 Jawaharlal Institute of Post Graduate Medical Education and ResearchDHANVANTRI NAGAR ,PUDUCHERRY 605006INDIA Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label 12/04/2017 23/03/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23513 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Metformin Response rate Phase 3/4 DB00703 N
JPRN-jRCTs031190167 Periopertive administration of flurbiprofen axetil for prevention of postoperative recurrence in patients with non-small cell lung cancer Recruiting non-small cell lung cancer
non-small cell lung cancer;non-small cell lung cancer arm A: Surgery alone
arm B: Intravenous drip infusion of 50mg of flurbiprofen axetil given perioperatively Relapse-free survival (RFS) Watanabe Katsuya All >= 20age old - Not applicable 420 Interventional Study randomized controlled trial, open(masking not used), active control, parallel assignment, prevention purpose 05/02/2020 23/12/2019 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs031190167 Localised/Locoregional Hospital/University/Research Institute Y N N Japan Lung Non-Small Cell Lung Cancer Flurbiprofen DFS/RFS/EFS Phase 2 DB04842 N
CTRI/2015/12/006454 Study of effect of metformin in patients with relapsed epithelial ovarian cancer Open to Recruitment Health Condition 1: null- carcinoma ovary Intervention1: Tab Metformin 500 mg: To assess the response of metformin on CA-125 levels in patients with carcinoma ovary post treatment under followup with rising CA-125 levels.
Control Intervention1: NONE: NOT APPLICABLE
Complete response or Partial responseTimepoint: 1 february 2016 Cancer Institute WIA - - 25 Cancer Institute (WIA)38, Sardar Patel RoadGuindy, Chennai 600036 Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 01/09/2015 22/12/2015 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9123 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N India Gynaecological Ovarian Epithelial Cancer Metformin Response rate Phase 2 DB00703 N
CTRI/2015/09/006204 A study of Oral chemotherapy after completion of radiation and chemotherapy vs observation in Carcinoma esophagus. Not Yet Recruiting Health Condition 1: null- Patients of carcinoma of esophagus Intervention1: Oral Metronomic: Oral metronomic chemotherapy is the study intervention in this trial. The metronomic chemotherapy consists of oral tablets of methotrexate and celecoxib.
Metronomic chemotherapy will be started within 13 weeks of completion of CTRT.
Oral methotrexate tablets 15mg/m2 will be self-administered weekly.
Capsule celecoxib will be self-administered twice daily in a dose of 200 mg BD continuously.The combination will be continued to a maximum of 12 months; unless prohibitive toxicity or disease progression occurs prior.
Control Intervention1: Observation: Patients on observation arm will receive standard treatment.
Overall SurvivalTimepoint: At the time of death or at last follow up Tata Memorial Center - - 300 Not applicable yet Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Other Blinding and masking:Not Applicable 28/09/2015 22/09/2015 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12600 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N India Head and Neck Laryngeal Cancer Celecoxib OS Phase 3 DB00567 N
ACTRN12621000784819 A preliminary study of the addition of prazosin to radiotherapy in men with prostate cancer Recruiting Prostate Cancer;
Prostate Cancer;Cancer - Prostate This trial will be a feasibility study with dose escalation of the investigational drug (prazosin). The study will follow a standard 3 + 3 model followed by dose expansion. Each participant will remain on the same dose level throughout their treatment. Once dose escalation is complete all new participants will then be enrolled into the dose expansion phase. During the 3 + 3 phase, three participants will be enrolled to each dose level. If there are no dose limiting toxicities (DLT) at the respective dose level the study will proceed to the next level. If one patient develops a DLT then an additional three patients will be enrolled into the dose level, should a second participant develop at DLT at the same level then the previous dose level will be defined as the maximum tolerated dose. It is planned that there will be 6 dose levels, 0.5mg, 1mg, 2mg, 3mg, 4mg and 5mg (all dosed twice daily), however if DLTs occur higher dose levels may not be reached.
Participants will commence prazosin one week prior to the commencement of radiotherapy. Prazosin will be provided as 1mg, 2mg and 5mg tablets and dosing will commence one week prior to radiotherapy to enable dose titration and continue until the end of radiotherapy, approximately 4-6 weeks based on prescribed radiotherapy treatment plan. The appropriate tablet strength will be provided to the participant based on their dosing level.
Participants will be enrolled into either the 0.5mg, 1mg, 2mg, 3mg, 4mg or 5mg dose levels, dosed twice daily. All patients will be commenced on 0.5mg (half of a 1mg tablet) of prazosin to be taken twice daily one week prior to the commencement of radiotherapy. For subsequent dose levels, the dose will be increased weekly.
Compliance will be assessed at weekly review by the returning of Protocol and treatment schedule compliance as a composite outcome. Compliance feasibility will be defined as = 80 compliance rate to the study protocol/treatment schedule. Treatment compliance will be defined as participants missing < 10 of prazosin doses and being able to complete all radiotherapy fractions. Treatment compliance will be assessed using participant dosing diaries and the return of medication packaging and unused tablets. Assessment compliance will be defined as a completion of = 80 required assessments.[ At the completion of radiotherapy and prazosin treatment.] GenesisCare Male 18 Years - No limit 30 GenesisCare Foundation;Griffith University Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group; 28/10/2022 22/06/2021 10/03/2023 https://anzctr.org.au/ACTRN12621000784819.aspx Localised/Locoregional Other N N N Australia Urological Prostate Cancer Prazosin Other (specify) Phase 1 DB00433 N
JPRN-UMIN000020681 Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer Complete: follow-up continuing Pancreatic cancer A:S-1+Metformin S-1 day1-14 of each 21-day cycle, until progression disease or completion of the planned 6 months Treatment for diabetes: Metformin 500mg/day day1-21, subsequently 750mg/day for 2 years
B:S-1 S-1 day1-14 of each 21-day cycle, until progression disease or completion of the planned 6 months Treatment for diabetes: Any diabetic treatment without Metformin for 2 years 2-year survival rate (overall survaival) National Hospital Organization All 20years-old - Not applicable 160 National Hospital Organization Interventional Study Parallel Randomized 26/01/2018 22/01/2016 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023796 Localised/Locoregional Hospital/University/Research Institute Y N N Japan GI Pancreatic Cancer Metformin OS Phase 2 DB00703 N
DRKS00012360 Pharmacokinetic Enhancement of Crizotinib plasmaconcentrations with Cobicistat or Itraconazole in AnaplasticLymphoma Kinase positive advanced Non-Small Cell LungCancer Patients Recruiting stopped after recruiting started
C34;Malignant neoplasm of bronchus and lung Group 1: Crizotinib 250 mg BID p.o. + 150 mg Cobicistat QD p.o. for 14 days
Group 2: Crizotinib 250 mg BID p.o. + Itraconazole 200 mg QD p.o. for 14 days Geometric mean ratio (90 confidence interval) of crizotinib AUC0-t and during, cobicistat
(itraconazole) treatment. Ruprecht-Karls University Heidelberg (Medical Faculty)University Hospital Heidelberg represented in law by its commercial directorDipl.-Volksw. Irmtraut G rkan. All 18 Years - None 16 Abt. Klinische Pharmakologie und PharmakoepidemiologieMedizinische Klinik Interventional Study Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: other 2016-002187-14 13/07/2017 21/04/2017 27/05/2024 http://drks.de/search/en/trial/DRKS00012360 Any/All Stages Hospital/University/Research Institute Y N N Germany Lung Non-Small Cell Lung Cancer Itraconazole Other (specify) Phase 1 DB00602 N
IRCT20210819052230N1 Study of the efficacy of memantine in metastatic colon cance Recruiting Metastatic colon cancer.
Malignant neoplasm of colon Intervention 1: Intervention group: Standard chemotherapy drugs for colon cancer + memantine Memantine, which is our intervention, will be administered orally at a dose of 20 mg per day. Thus, in the first week, 5 mg daily and then 5 mg per week will be added and eventually continued at a dose of 20 mg per day for three months. Intervention 2: Control group: Standard chemotherapy drugs for colon cancer without prescribing memantine. Quality of life in patient with colon cancer. Timepoint: Beginning and end of the study (third month). Method of measurement: QLQ-C30 Questionnaire.;The size of tumor in patients with colon cancer. Timepoint: Beginning and end of the study (third month). Method of measurement: CT scan. Oroumia University of Medical Sciences All 18 years - no limit 50 Oroumia University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, which will be allocated to 25 people in each group in a block plan, first, because there are two groups A and B, there will be 25 groups of 2, with group A being the intervention group and group B being the control group. After determining the cases, 25 cases will be selected using a random number table, and after determining the order, the list of patients will be randomly divided into two groups, Blinding description: In this study, an epidemiologist colleague will randomly divide patients into two groups, and the physician will prescribe medication for the intervention group. The participants, researcher, and data analyst are blind. 01/10/2022 29/01/2022 02/07/2022 http://en.irct.ir/trial/60821 Advanced/Metastatic Hospital/University/Research Institute Y N N Iran GI Colon Cancer Memantine Response rate; QoL Phase 2 DB00170 N
IRCT20211213053377N1 The radioprotective effect of metformin against radiotherapy-induced complications Recruiting Prostate cancer.
Malignant neoplasm of prostate Intervention 1: Intervention group: Patients will receive oral metformin tablets (Chemi Darou Pharmaceutical Company, Iran) at a single dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. Metformin tablets will be taken 2 hours before radiotherapy. Intervention 2: Control group: In the second group, patients will receive a placebo with a similar dose of 1000 mg per day before the start of radiotherapy until one month after radiotherapy. The appearance of a placebo is similar to that of metformin. The Number of blood cells. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory measurement of blood cell count.;Genotoxicity. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory count of micronucleus in peripheral blood lymphocytes.;Urinary complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute urinary complications due to radiation therapy based on physician examination and patient symptoms.;Gastrointestinal complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute gastrointestinal complications due to radiation therapy based on physician examination and patient symptoms. Ahvaz University of Medical Sciences Male 18 years - no limit 60 Ahvaz University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(60)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group (intervention) and the second 30 people will place in the second group (control). A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomizati 21/01/2022 20/01/2022 05/02/2022 http://en.irct.ir/trial/60641 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N Iran Urological Prostate Cancer Metformin Biomarker Phase 3 DB00703 N
IRCT20170728035349N2 Evaluation of Metformin impact on the downstaging of rectal cancer patients undergoing neo-adjuvant chemo-radiotherapy Recruiting Rectal Cancer.
Malignant carcinoid tumor of the rectum;C7A.026 Intervention 1: Intervention group: 20 patients in the intervention group receive one metformin 500 tablet daily from Tehran Daroo Company at the same time with 28 sessions of chemoradiotherapy. Intervention 2: Control group: One placebo daily with 28 sessions of chemoradiotherapy. Down Staging in Rectal Cancer Patients in Neo-adjuvant and Metformin Concomitant Recipients. Timepoint: MRI and biopsy of the rectal mucosa to determine the stage of the tumor and compare with similar cases performed at the beginning of the study, Follow-up of patients in both groups at intervals of 1, 3 and 6 months in terms of possible treatment complications, non-recurrent survival, cancer-specific survival and overall survival. Method of measurement: MRI. Zanjan University of Medical Sciences All 20 years - 70 years 40 Zanjan University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two groups: metformin recipients (group M) and placebo recipients (group P). For this purpose, random block methods with size 2 will be used and the random sequence of this allocation will be generated by STATA16 software, Blinding description: Due to the ambiguity of this study (patients and physicians prescribing the drug are not aware of the main drug and placebo), metformin 500 mg and placebo were indefinitely given to the patient at the end of each radiotherapy session and Its consumption is ensured. 29/01/2022 15/01/2022 02/07/2022 http://en.irct.ir/trial/60949 Neo-adjuvant/Window Localised/Locoregional Hospital/University/Research Institute Y N N Iran GI Rectal Cancer Metformin Other (specify) Phase 3 DB00703 N
IRCT20200608047702N1 The effect of finasteride in the prevention of bladder tumor recurrence Recruiting bladder cancer.
Malignant neoplasm of bladder, unspecified;C67.9 Intervention 1: Intervention group: Finasteride ( Daru Pakhsh CO. Tehran, Iran) receive 5 mg /day and complications and response to treatment are evaluated every three months. Intervention 2: Control group: Receive placebo (in the form of finasteride tablets) (Construction of Faculty of Pharmacy, Tabriz University of Medical Sciences)tablet per day for up to one year. Prevention of recurrence of bladder cancer. Timepoint: before intervention and every 3 months for a period of one year. Method of measurement: cystoscopy pathology report. Tabriz University of Medical Sciences All 18 years - 70 years 124 Tabriz University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 124 envelopes are prepared with 62 active and 62 placebo cards and shuffled. Patients are allocated the next study number (1 € 124) in sequence after opening the sealed envelopes to either drug or placebo group, Blinding description: The researcher does not know whether the patient being evaluated belongs to the placebo group or the finasteride group. The patients also do not know if they have used a placebo or finasteride. Drugs and placebos are similar in appearance, such as color, shape, and so on. The patient (placebo or treatment groups) receives the encoded drug. 06/05/2021 25/12/2021 01/11/2022 http://en.irct.ir/trial/48767 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute N N N Iran Urological Bladder Cancer Finasteride Recurrence rate Phase 3 DB08868 N
IRCT20200409047007N3 The effect of concurrent administration of melatonin and neoadjuvant Chemotherapy on the pathological response in breast cancer patients Recruiting Breast Cancer.
Malignant neoplasm: Breast, unspecified;C50.9 Intervention 1: Intervention group: Patients are prescribed a 10 mg tablet of melatonin at bedtime during a 5-month course of chemotherapy. Intervention 2: Control group: Patients in the control group are given one placebo tablet (similar to melatonin tablets) each night during a 5-month course of chemotherapy. Pathological response. Timepoint: surgery after neoadjuvant chemotherapy. Method of measurement: The pathological response after neoadjuvant chemotherapy is assessed according to the Chevallier system as follows:1- Pathological complete response: Disappearance of all the tumor cells in breast and lymph nodes2- Pathological partial response: Presence of invasive carcinoma with stromal alterations3- Pathological no response: little modification in the original tumor appearance. Mashhad University of Medical Sciences Female 30 years - 60 years 52 Mashhad University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly placed in blocks of 6. In each block, 3 patients receive melatonin and 3 patients receive placebo and patients are placed in blocks in the order of enrollment, Blinding description: Randomization was performed by Dr. Fazelipour and only she knows the type of medicine that is prescribed to each patient. The coded drug packages will be placed in the pharmacy next to the chemotherapy ward and will be delivered to each patient according to the code given to him. Patients, planners, physicians, and those who analyze the data are unaware of the type of medication each patient is receiving. 12/06/2021 12/02/2021 01/11/2022 http://en.irct.ir/trial/59341 Neo-adjuvant/Window Localised/Locoregional Hospital/University/Research Institute Y N N Iran Breast Any Breast Cancer Melatonin Response rate Phase 3 DB00814 N
KCT0006304 An Open Label, Single-Arm, Phase I Exploratory Trial to Assess the Safety and Preliminary Efficacy of mFOLFIRINOX with Hydroxychloroquine and Chlorphenesin carbamate in Patient with in Inoperable Locally Advanced or Metastatic Pancreatic Cancer Active, not recruiting ;Neoplasms Drug : This study is a single-arm trial and mFOLFIRINOX therapy, the backbone therapy of this trial, chlorphenesin carbamate 250 mg, and hydroxychloroquine 200 mg will be administered orally twice daily for up to 48 weeks. AE, Lab Test, Vital sign, 12-lead ECG, Physical examination, ECOG PS Asan Medical Center All 19(Year) - 80(Year) 40 CytoGen;ONCOCROSS Interventional Study Primary Purpose : Treatment, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable 21/12/2021 30/06/2021 05/02/2023 https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=24522 Advanced/Metastatic Hospital/University/Research Institute N N N Korea, Republic of GI Pancreatic Cancer Hydroxychloroquine Biomarker Phase 1 DB07118 N
ChiCTR2100047864 A clinical study of carrelizumab and apatinib mesylate combined with propranolol in the treatment of advanced cholangiocarcinoma Pending Cholangiocarcinoma Test group:Patients receiving Carrelizumab 200mg QD+ apatinib mesylate tablets 250mgQD+ propranolol 40mg BID for 3 weeks; objective response rate 1 yeaer after treatment; Hunan Provincial Tumor Hospital All 18 - Test group:30; Jiangsu Hengrui Pharmaceutical Co. Ltd Interventional Study Single arm 30/06/2021 27/06/2021 03/07/2022 http://www.chictr.org.cn/showproj.aspx?proj=129040 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Cholangiocaricnoma Propranolol Response rate Phase 2 DB00165 N
ChiCTR2100047608 Clarithromycin added to pomadomide-cyclophosphamide-dexamethasone (Cla-PCd) versus pomadomide cyclophosphamide-dexamethasone (PCd) in relapsed or refractory multiple myeloma: a prospective, multicentre, randomised, controlled clinical trial Recruiting Multiple Myeloma Group 2:pomalidomide combined with cyclophosphamide, clarithromycin, dexamethasone;Group 1:pomalidomide combined with cyclophosphamide and dexamethasone; Overall response rate; Shanghai Changzheng Hospital All 18 - 100 Group 2:68;Group 1:68; Self-funded Interventional Study Parallel 07/01/2021 20/06/2021 21/02/2022 http://www.chictr.org.cn/showproj.aspx?proj=128373 Recurrent/Refractory Hospital/University/Research Institute Y N N China Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 4 DB00283 N
ChiCTR2100046201 A prospective, multicenter, randomized, controlled study on whether long-term oral antibiotics can effectively reduce the incidence of postoperative tumor recurrence and metastasis in patients with colorectal cancer Recruiting colorectal cancer experimental group:Metronidazole;control group:placebo; Incidence of postoperative liver metastasis; The First Affiliated Hospital of Air Force Medical University All - experimental group:1000;control group:1000; No Interventional Study Parallel 30/07/2021 05/09/2021 21/12/2021 http://www.chictr.org.cn/showproj.aspx?proj=125730 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metronidazole Recurrence rate Not available/Missing DB01011 N
IRCT20200313046756N2 Evaluation of the Effect of deferasirox on the treatment of ??Acute myeloid leukemia Pending Acute myeloblastic leukemia.
Acute myeloblastic leukemia;C92.0 Intervention 1: Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with oral intake of Deferasirox capsule 360 mg daily for 28 days. Intervention 2: Control group: receive the standard treatment Cytarabine and idarubicin (7+3) without Placebo. The number of white blood cells. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count.;Number of red blood cells. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count.;Platelet numbers. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count.;Percentage of CD34 + leukemia blasts of bone marrow biopsy specimen. Timepoint: on days 14 and 28. Method of measurement: Flow cytometry with CD34 monoclonal antibody. Kerman University of Medical Sciences All 18 years - 65 years 40 Kerman University of Medical Sciences;Nano Fanavaran Alvand pharmaceutical co.;AryaTinaGene biopharmaceutical co. Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: one group receiving standard treatment(without placebo) and the other group receive the standard treatment and interventional drug, Randomization description: Patients divide into two groups n = 20 (including dropouts). Block permuted randomization method uses, based on that, patients organize in a three-level prognosis(A, B, C) in each three-person block of any interventional group. According to the random numbers chart, the researchers consider even numbers for the control group and odd numbers for the intervention group, then put their hand on one of the numbers and move upwards and record the numbers, and assign the patients based on that individual group, Blinding description: People will be kept blind.;Patient: Receives the intervention drug in combination with the daily meals;outcome assessor: The information of each patient is p 23/09/2022 05/08/2021 29/08/2022 http://en.irct.ir/trial/51397 Any/All Stages Hospital/University/Research Institute Y N N Iran Leukemia Acute Myeloid Leukemia, Adult Deferoxamine Other (specify) Phase 3 DB04932 N
ChiCTR2100044011 Observational clinical study of anlotinib hydrochloride combined with gefitinib in first-line treatment of EGFR-sensitive mutations in advanced NSCLC Recruiting Advanced non-squamous non-small cell lung cancer A+T:A+T;Gefitinib + Anlotinib + Metformin combination therapy:Gefitinib + Anlotinib + Metformin combination therapy;Gefitinib + Anlotinib + Metformin combination therapy (Patients with type 2 diabetes requiring oral metformin):Gefitinib + Anlotinib + Metformin; DCR; The First Affiliated Hospital of Xinxiang Medical College All 18 - 75 A+T:20;Gefitinib + Anlotinib + Metformin combination therapy:20;Gefitinib + Anlotinib + Metformin combination therapy (Patients with type 2 diabetes requiring oral metformin):20; CSCO-Pilot Tumor Research Fund Interventional Study Parallel 03/08/2021 03/06/2021 07/12/2021 http://www.chictr.org.cn/showproj.aspx?proj=56165 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N China Lung Non-Small Cell Lung Cancer Metformin Other (specify) Other DB00703 N
ChiCTR2100042869 The Efficacy and Safety of Sirolimus Early Conversion Protocol in Liver Transplant Patients with Hepatocellular Carcinoma: a Single-Arm, Multi-Center, Prospective Study Recruiting Hepatocellular carcinoma experimental group:Sirolimus; Recurrence-free survival; Shulan (Hangzhou) hospital All 18 - 70 experimental group:397; self-raised Interventional Study Single arm 15/02/2021 30/01/2021 30/08/2021 http://www.chictr.org.cn/showproj.aspx?proj=121236 Localised/Locoregional Hospital/University/Research Institute N N N China GI Liver Cancer Sirolimus DFS/RFS/EFS Not available/Missing DB01261 N
ChiCTR1800017822 A Prospective clinical trial of the efficacy and safety of zolledronic acid in the adjuvant treatment of breast malignant phyllodes tumors Adjuvant zoledronic acid in patients with breast malignant phyllodes tumors Recruiting breast malignant phyllodes tumor Case series:receive 4 mg zoledronic acid intravenously once a month, for 2 years; 5 years disease-free survival;lung metastasis;bone metastasis; Sun Yat-sen Memorial Hospital, Sun Yat-sen University Female 12 - 70 Case series:28; Natural Science Foundation of China (81502301) Treatment Study Non randomized control 09/01/2018 16/08/2018 24/01/2022 http://www.chictr.org.cn/showproj.aspx?proj=29903 Localised/Locoregional Hospital/University/Research Institute N N N China Breast Breast - Other Zoledronic Acid DFS/RFS/EFS; Other (specify) Phase 2 N
DRKS00025207 Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy Recruiting
C71;Malignant neoplasm of brain Group 1: Meclofenamate, oral administration, duration of treatment: 224 days or until tumor progression (what occurs first). Dosage 100mg - 400mg daily divided into two doses. Application additive to standard temozolomide dosing (TMZ 150-200 mg/m2/d days 1-5/28), 8 four weeks courses). - Phase I: Incidence of dose-limiting toxicities (DLTs) during the first 8 weeks/56 days of MFA treatment.
- Phase II: Progression-free survival (PFS) as measured from the day of randomization until diagnosis of progressive disease determined by MRI (RANO criteria) in the local center. In a sensitivity analysis, the PFS analysis does also include patients from phase I who received MFA at the same dose as applied in phase II (PFS measured from day of trial inclusion)
Medizinische Fakult t der Universit t BonnRheinische Friedrich-Wilhelms Universit t Bonn All 18 Years - None 72 Bundesministerium f r Bildung und Forschung Dienstsitz Bonn Interventional Study Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment 2021-000708-39 11/04/2022 20/07/2021 27/05/2024 http://drks.de/search/en/trial/DRKS00025207 Recurrent/Refractory Hospital/University/Research Institute N N N Germany CNS Glioblastoma Meclofenamate Safety and/or Dose; PFS Phase 1/2 DB00784 N
JPRN-UMIN000013951 Phase II study of concurrent chemotherapy with itraconazole in advanced gynecologic tumors. Complete: follow-up continuing Gynecologic cancer itraconazole with chemotherapy PFS, Response rate, OS, AEs, QOL, molecular profiling Department of Obstetrics and Gynecology, Hyogo College of Medicine Female 20years-old - 75years-old 16 Hyogo College of Medicine Interventional Study Single arm Non-randomized 20/05/2014 20/05/2014 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016257 Advanced/Metastatic Hospital/University/Research Institute N N N Japan Gynaecological Any gynaecological cancers Itraconazole Response rate; PFS Phase 2 DB00602 N
CTRI/2010/091/000441 Phase III, Multi-centre, Double Blind, Randomized Placebo Controlled Trial of Aspirin for Duke C and High Risk Dukes B Colorectal Cancers Open to Recruitment Health Condition 1: null- Dukes C and High Risk Dukes B Colorectal Cancer Intervention1: Aspirin: 200 mg OD for 3 years
Control Intervention1: Placebo: 200 mg OD for 3 years
1. Disease free survival for all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer ptient sub groups)Timepoint: 3 years;Disease free survival for colon cancer (high risk Dukes B and Dukes C colon cancer)Timepoint: 3 years National Cancer Centre Department of Medical Oncology Singapore - - 2660 NIL;NIL Interventional Study Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded ICR02/ASCOLT;NCC IRB Ref No: 07-32-LGI 27/12/2010 17/05/2010 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1629 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Singapore GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 3 DB01048 N
NTR1250 A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small-cell lung cancer patients with high-risk for recurrence: NVALT 8B Recruiting Non-small-cell lung cancer Within 4-6 weeks after surgery all patients will receive 4 cycles of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day 1 every 3 weeks. Patients in de nadroparin arm will receive nadroparin s.c. daily for 16 weeks, 2 weeks therapeutic dose en 14 weeks half-therapeutic dose. The main endpoint is recurrence-free survival. UMCGHanzeplein 19700 RB Groningen - - 600 Pharmaceutical industryEli Lilly and GlaxoSmithKline' Interventional Study Randomized controlled trial, Open (masking not used), N/A , unknown, Parallel NL1205;NTR1250; : NVALT 8-B;ISRCTN wordt niet meer aangevraagd 11/01/2007 17/03/2008 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/24423 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands Lung Non-Small Cell Lung Cancer Nadroparin DFS/RFS/EFS Phase 3 DB12092 N
CTRI/2019/09/021263 Role of affordable oral cancer drugs in advanced mouth cancer - Feasibility study. Open to Recruitment Health Condition 1: C06- Malignant neoplasm of other and unspecified parts of mouth Intervention1: Drugs - Methotrexate and Celecoxib: Methotrexate
Dose - 15 mg/m2 of BMI once a week
Duration - 8 weeks
Route - Oral
Celecoxib
Dose -200 mg twice daily
Duration - 8 weeks
Route - Oral
Control Intervention1: Not Applicable: Not Applicable
To study the feasibility of low cost, oral metronomic therapy in locally advanced borderline oral cancers.Timepoint: 4 weeks and 8 weeks All India Institute of Medical Sciences Bhubaneswar - - 50 Drugs used are standard chemotherapy drugs and will be purchased by patient themselves. The point has been discussed in ethics committee and approved. Rest of the imaging studies and blood investigations are being done by AIIMS, Bhubaneswar free of cost. Address is - Surgical Oncology OPD, Department of Surgical Oncology, AIIMS, Patrapada, Bhubaneswar, Odisha - 751019 Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 16/09/2019 16/09/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36718 Advanced/Metastatic Hospital/University/Research Institute N N N India Head and Neck Oropharyngeal Cancer Celecoxib Other (specify) Not available/Missing DB00567 N
NTR2655 Potential role of vitamin D treatment in breast cancer. Pending Vitamin D, breast cancer, apoptosis, proliferation Oral administration of colecalciferol 40,000 IU/day, the duration of this therapy will be about 3-8 weeks (time frame between diagnosis of breast cancer and definitive surgery). To study the influence of vitamin D on immunohistochemical marker Ki 67 (proliferation marker) in breast cancer. This marker will be defined in the biopsy specimen and in the tumour resection specimen. The mean difference between these two marker values will be examined between the intervention and the control group. none - - 110 Fund Coronis, Researchfund of department of gynaecologists Enschede Interventional Study Randomized controlled trial, Double blinded (masking used), Placebo, Parallel NL2537;NTR2655;NL33552.044.10;ISRCTN wordt niet meer aangevraagd. 02/01/2011 16/12/2010 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/28013 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands Breast Any Breast Cancer Cholecalciferol Biomarker Not available/Missing Not found in DrugBank N
JPRN-UMIN000004525 The effect of combination of valproic acid and anti-tumor drug on pancreatic and biliary cancer Pending unresectable or reccurrent pancreatic cancer and biliary cancer (20 patients) To administer valproic acid 15mg/kg twice a day.We estimate the blood concentration of valproic acid once a month. If the patients have the no side effects, we will continue to administer valproic acid. Regarding S-1, we administer this drug twice a day in alternate-day regimen. tumor marker and tumor size Department of surgery, Tokushima university hospital All Not applicable - Not applicable 20 None Interventional Study Single arm Non-randomized 12/01/2010 15/11/2010 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005412 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Japan GI Pancreatic Cancer; Cholangiocaricnoma Valproic Acid Response rate; Biomarker Phase 1/2 DB00177 N
ACTRN12614000513617 ASCOLT Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers. Active, not recruiting Colorectal Cancer;
Colorectal Cancer;Cancer - Bowel - Back passage (rectum) or large bowel (colon) Eligible participants will be randomised to the study in 1:1 ration to either Aspirin arm: 200 mg Aspirin (oral tablet) once a day for 3 years or Placebo equivalent.
The study treatment is given as adjuvant therapy
Drug compliance will be monitored via drug dispensations and drug returns, recorded on drug accountability logs at each study visit.
Noncompliance is defined as omission of more than 30 of the study period that the patient is on the study. Disease Free Survival (DFS) among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups)
[During treatment: prior to each treatment cycle. Patient will have 3 monthly assessments for 3 years (month 3 to month 36) followed by 6 monthly assessments for additional 2 years (month 42 to month 60).] Australasian Gastro-Intestinal Trial Group (AGITG) All 18 Years - No limit 460 Cancer Australia;Bowel Cancer Australia Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy; 28/08/2014 15/05/2014 27/02/2023 https://anzctr.org.au/ACTRN12614000513617.aspx Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N Australia GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 3 DB01048 N
JPRN-UMIN000003493 Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients Recruiting early breast cancer Neoadjuvant chemotherapy: CEF (EpiADR 100mg/m2 D1, CPA 500mg/m2 D1, 5FU 500mg/m2 D1 per 3 weeks) 4 cycles, then weekly paclitaxel 80mg/m2 for 12 weeks. zoledronic acid: 4mg + saline 100ml div for 15 minutes, per 3-4 weeks, 6 cycles Pathological response rate Division of Medical Oncology and Breast Surgery, Cancer Institute Hospital Female 20years-old - 70years-old 30 None Interventional Study Single arm Non-randomized 04/01/2010 15/04/2010 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004232 Localised/Locoregional Hospital/University/Research Institute N N N Japan Breast Any Breast Cancer Zoledronic Acid Response rate Phase 2 N
CTRI/2015/01/005405 Study evaluating survival benefit of use of low dose continuous chemotherapy drugs along with surgery and radiation in treatment of advanced stage cancers of the oral cavity Open to Recruitment Health Condition 1: null- Operable Oral Cancers Stage III and IV Intervention1: Metronomic Therapy: Tablet Methotrexate
Tablet Celecoxib
Intervention2: Metronomic Therapy in addition to standard surgery and adjuvant radiation / chemoradiation: Tablet Methotrexate 15mg/m2 and Tablet Celecoxib 200 mg twice a day given every week for 4 weeks as Neoadjuvant before surgery, for 4 weeks as Intermediate between surgery and radiation therapy and for 12 months after radiation as Maintenance. Total duration of therapy is 14 months.
Control Intervention1: Standard Therapy: Surgery followed by Adjuvant Radiation / Chemoradiation
Disease Free SurvivalTimepoint: 3 years Department of Atomic Energy Clinical Trials Centre - - 400 DAECTC Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label 14/08/2013 14/01/2015 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8782 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N India Head and Neck Oropharyngeal Cancer Celecoxib DFS/RFS/EFS Phase 3 DB00567 N
CTRI/2018/07/014865 Sorafenib and supportive medication in advanced Hepatocelluar cancer Not Yet Recruiting Health Condition 1: C220- Liver cell carcinoma Intervention1: Sorafenib, Metformin and Atorvastatin: The 1st leg of the study will recruit 10 patients and they will be started on
Sorafenib 400mg BD + Atorvastatin 10mg OD + Metformin 500mg BD
Level 2 ?? The 2nd leg of the study will recruit 10 patients and they will be started on
Sorafenib 600mg per day + Atorvastatin 10mg OD + Metformin 500mg BD
Level 3 ?? The 3rd leg of the study will recruit 10 patients and they will be started on
Sorafenib 200mg BD + Atorvastatin 10mg OD + Metformin 500mg BD
Level 4 ?? The 4th leg of the study will recruit 10 patients and they will be started on
Sorafenib 200mg OD + Atorvastatin 10mg OD + Metformin 500mg BD
Route of administration :Oral
Control Intervention1: NA: NA
1. Safety of combining Sorafenib with Atorvastatin and Metformin
2. Adverse events of combination SAM
Timepoint: 30 months Tata Memorial Hospital - - 40 Intramural:Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai Extramural:Educational Grant form DrReddys Pvt limited B/2/337 road no 3 banjara hills hyderbad telegana pin 500034 Interventional Study Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label Study protocol version 3.0 dated 19/03/2018 27/08/2018 13/07/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=27179 Advanced/Metastatic Hospital/University/Research Institute N N N India GI Liver Cancer Atorvastatin; Metformin Safety and/or Dose Phase 1 DB01117; DB00703 N
NL7726 Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients Recruiting metastasized neuroendocrine tumors (NETs) 14 days treatment with valproic acid (30mg/kg body weight/day) and hydralazine (150mg / day) The primary endpoint will be the percentage of patients that will have an uptake of
68Ga-DOTATATE in the tumor equal to or above that of the liver after the 14 days
treatment period. Erasmus MC, Rotterdam, the Netherlands - - 10 Erasmus MC Interventional Study N/A: single arm study, Open (masking not used), N/A , unknown, Other NL7726;METC Erasmus MC : MEC-2019-0031 05/01/2019 13/05/2019 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/23147 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands Endocrine Neuroendocrine Tumours Hydralazine; Valproic Acid Biomarker Not available/Missing DB01611; DB00177 N
ACTRN12620000156987 Trial of propranolol to assess the spread of melanoma Recruiting Melanoma;
Melanoma;Cancer - Malignant melanoma Consenting patients will be awaiting a sentinel node biopsy.
They will be randomized 1:1 to receive a daily oral dose of either (1) 40mg twice daily of propranolol or (2) a placebo.
The duration of administration will be from the day of consent until the day of the sentinel node biopsy. This time period is expected to be 2-3 weeks.
The drug and the placebo will be in capsule form. The dose will be 40mg twice a day.
Participants will be asked to return their capsule bottles in order to monitor adherence. This is a composite primary outcome.
The outcome measure will be signs of activation of genes induced by Sox18/RBPJ activity: IL33 and VCAM reflecting Sox18 re-expression and RBPJ activity.
Outcome will be assessed on the sentinel node by gene expresion analysis (RT-PCR) and by immunofluorescence.
[3 weeks post commencement of trial drug/placebo] University of Queensland Diamantina Institute All 18 Years - No limit 24 NHMRC Interventional Study Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; 12/02/2021 13/02/2020 11/08/2021 https://anzctr.org.au/ACTRN12620000156987.aspx Localised/Locoregional Hospital/University/Research Institute Y N N Australia Skin Melanoma Propranolol Biomarker Phase 1 DB00165 N
CTRI/2021/11/038016 An Efficacy and Safety Study of Erdafitinib (JNJ42756493) in Participants with Urothelial Cancer Closed to Recruitment of Participants Health Condition 1: N33- Bladder disorders in diseases classified elsewhere Intervention1: Erdafitinib: 8 mg orally once daily for 28 days on a 28 day cycle.
Intervention2: Midazolam: DDI substudy will receive pretreatment with single dose of midazolam 2.5mg oral solution on Day -2 and single dose of midazolam on Day 13.
Intervention3: Metformin: DDI substudy will receive pretreatment with single dose of metformin 1000mg on Day -1 and single dose of metformin on Day 14.
Control Intervention1: NA: NA
Plasma Concentration of Midazolam and its Metabolite (1-OH midazolam)Timepoint: Plasma Concentration of Midazolam and its Metabolite (1-OH midazolam) at Day-2 and Day 15 Janssen Research Development LLC - - 22 Janssen Research Development , LLC Interventional Study Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label 12/01/2022 12/11/2021 16/10/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57278 Advanced/Metastatic Company N N N India Urological Urethral Cancer Metformin; Midazolam Safety and/or Dose Phase 2 DB00703; DB00834 N
CTRI/2019/09/021213 A study to evaluate the role of modified regular interval based combined oral chemotherapy that regresses tumor cell development of various forms which is indicated for the treatment of High-Risk Medulloblastoma (a type of brain tumor) Open to Recruitment Health Condition 1: C716- Malignant neoplasm of cerebellum Intervention1: C.O.M.B.A.T: Combined Oral Metronomic Bio-differentiating Antiangiogenic Treatment
Comprising Of Following Drug Regimen: Agent A: Temozolamide
60mg/m2/day from week 0 to week 6, to be given orally once a day in
empty stomach Agent B: Isotretinoin 100mg/m2/day 2 weeks on and 2
weeks, to be given orally in two divided doses to be given post meals
preferably with fatty foods like butter, cheese etc. Agent C: Etoposide
25mg/m2/day from week 9 to week 12, to be given orally in once a day
dose post meals Agent D: Sodium valproate 20mg/kg/day daily for 12
weeks all given per orally in two divided doses post meals. Each cycle
constitutes 12 weeks and 4 such cycles would be given for a duration of 52
weeks without any interruptions.
Control Intervention1: Observational
Arm: To observe after completion of the conventional therapy on every three
months for 30 months and then for 6 months till completion of 5 years
To determine improvement in Event Free SurvivalTimepoint: On monthly follow-up visit till one year and followed by 3 monthly follow-up visit for further 2 years. TMC Research Administration Council - - 128 TMC Research Administration Council, TRAC Office 3rd floor Main building Tata Memorial Hospital Dr Ernest Borges Road Parel. Mumbai. 400012 Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label 17/09/2019 12/09/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36714 Localised/Locoregional Hospital/University/Research Institute Y N Y India CNS Medulloblastoma Valproic Acid DFS/RFS/EFS Phase 2 DB00177 N
JPRN-UMIN000000813 Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer Recruiting Previously treated non-small-cell lung cancer Transdermally applied nitroglycerin, 10 mg/day, for consecutive 5 days between before the start of chemotherapy using 36 mg/m2 of amrubicin, D1-3, every 4 weeks and the day 2 of chemotherapy Progression free survival Division of Clinical Trial Design and Management, Translational Clinical Center, Kyoto University Hospital All 40years-old - Not applicable 60 Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government Interventional Study Single arm Non-randomized 09/01/2007 12/09/2007 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000973 Recurrent/Refractory Hospital/University/Research Institute N N N Japan Lung Non-Small Cell Lung Cancer Nitroglycerin PFS Phase 2 DB01422 N
JPRN-UMIN000003905 Phase I/II study of Aurora-A kinase peptide vaccine against hematological malignancies in combination with Pertussis vaccine (Pelita III strain) as an adjuvant. Recruiting Conventional therapy-resistant acute or chronic leukemia, elderly patients with hematological malignancies who are not eligible for standard chemotherapy and/or allogeneic or autologous hematopietic stem cell transplantation, relapsed acute or chronic leukemia and advanced phase of myelodysplastic syndrome after allogenic or autologous hematopietic stem cell transplantation, acute leukemia in 1st remission with high risk of relapse. Cohort1 patients receive 0.5mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
Cohort2 patients receive 1.0mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
Cohort3 patients receive 2.0mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine. Adverse event profile and anti-leukemia effect. Department of Bioregulatory All 20years-old - 80years-old 9 Grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan Interventional Study Parallel Non-randomized 07/01/2010 12/07/2010 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004697 Any/All Stages Hospital/University/Research Institute N Y N Japan Leukemia; Other Haem-onc Any leukemias; Myelodysplastic Syndromes Pertussis vaccine Safety and/or Dose Phase 1/2 DB00780 N
JPRN-jRCTs011180011 Neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer Recruiting pancreatic cancer
pancreatic cancer;D010190;pancreatic cancer Duration: 3 months
Dose
Neoadjuvantchemoradiation: Gemcitabine(150mg/m2/w)+RT(50.4G/28f)
Metformin: from 5days before starting neoadjuvant chemoradiation until surgery. (1500mg/3x);D020360;Neoadjuvant therapies the ratio of histological remnant cancer cells Taketomi Akinobu All >= 20age old - <= 80age old 40 Interventional Study single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose UMIN000017694 28/07/2015 12/03/2019 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs011180011 Advanced/Metastatic Hospital/University/Research Institute N N N Japan GI Pancreatic Cancer Metformin Biomarker Phase 2 DB00703 N
CTRI/2020/06/025818 Effect of Vitamin D and turmeric in lymphoma patients. Not Yet Recruiting Health Condition 1: C833- Diffuse large B-cell lymphoma Intervention1: Cholecalciferol (Vitamin D capsules) and Curcuma longa (Turmeric capsules): Oral Cholecalciferol 2000 IU once daily and Oral Curcuma longa 550 mg thrice daily with standard R-CHOP therapy for 6 to 8 months
Intervention2: Cholecalciferol capsules as an add-on therapy to R-CHOP: Oral Cholecalciferol 2000 IU once daily with standard R-CHOP therapy for 6 to 8 months
Intervention3: Tab. Curcuma longa as an add on therapy to R-CHOP: Oral Curcuma longa 550 mg thrice daily with standard R-CHOP therapy for 6 to 8 months
Control Intervention1: R-CHOP: Standard R-CHOP regimen at an interval of 21 days for 6-8 months
Event Free Survival at the end of two years (EFS24) of diagnosis in patients with DLBCLTimepoint: Two years JIPMER Intramural fund - - 80 JIPMER Interventional Study Randomized Factorial Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label 01/07/2020 11/06/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44026 Localised/Locoregional Hospital/University/Research Institute Y N N India Lymphoma Non-Hodgkin Lymphoma, Adult Cholecalciferol DFS/RFS/EFS Not available/Missing Not found in DrugBank N
CTRI/2013/06/003734 Low dose chemotherapy versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies Closed to Recruitment of Participants Health Condition 1: null- Refractory Childhood cancer Intervention1: Low dose chemotherapy: Etoposide(50 mg/m2/d) Thalidomide (at 3mg/kg/d)
Celecoxib (100 mg BID for patients 20 kg, 200 mg BID for patients 20 ??50 kg, and 400 mg BID for patients 50 kg)Cyclophosphamide (2.5 mg/kg/d to a maximum of 100 mg/d)
Total duration of therapy: 6 cycles of 21 days
Control Intervention1: Best supportive care: Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration)
? Capsules of same size and color as used in metronomic therapy
Best supportive care
? Management of pain as per WHO standard for pain management
Total duration of therapy: 6 cycles of 21 days
1.To assess the effect of metronomic chemotherapy on PFS.Timepoint: May 2013 to June 2015 Nil - - 200 Nil Interventional Study Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded 30/06/2013 11/06/2013 03/06/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6693 Palliative Recurrent/Refractory Hospital/University/Research Institute N N Y India Multiple cancer types Any solid tumours Celecoxib PFS Phase 3 DB00567 N
RPCEC00000367 Doxycycline for prostate cancer Recruiting Prostate cancer;Prostatic Neoplasms;Genital Neoplasms, Male;Urogenital Neoplasms ;Prostatic Diseases;Genital Diseases, Male ;Male Urogenital Diseases Intervention Experimental Group (group A): You will receive doxycycline 100 mg every 24 hours for 6 months, plus its standard treatment, which consists of bicalutamide 50 mg orally per day, and leuproline 22.5 mg in subcutaneous application every three months. This dose is less than the maximum previously recommended for chronic treatments such as acne conglobata. The commercial presentation for human use is in 100mg pills, so patients in the experimental group will take 1 pill every 24 hours.
Control Group Intervention (group B): You will receive your standard treatment as indicated by current clinical practice (bicalutamide 50mg orally per day, and leuproline 22.5mg in subcutaneous application every three months), plus a bottle of placebo pills that your doctor will provide. monthly in his office with the indication to take 1 pill every 24 hours, for 6 months.;Doxycycline ;Leuprolide ;Tablets ;Placebos ;Administration, Oral;Injections, Subcutaneous;Bicalutamida Complete response (25 reduction in serum specific prostate antigen). Measuring time: 3 and 6 months. Medical School of the University of Colima, Mexico Male 18 years - 85 years 40 Mexico Mexican Social Security Institute Interventional Study Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment 14/08/2020 11/05/2021 27/05/2024 https://rpcec.sld.cu/en/trials/RPCEC00000367-En Advanced/Metastatic Hospital/University/Research Institute Y N N Mexico Urological Prostate Cancer Doxycycline Response rate Phase 2 DB04855 N
ACTRN12622000016730 HER2Pro 1B - Addition of prochlorperazine to paclitaxel, trastuzumab, and pertuzumab for previously untreated HER2-positive metastatic breast cancer: a phase 1 dose de-escalation study Recruiting Metastatic HER2-positive breast cancer;
Metastatic HER2-positive breast cancer;Cancer - Breast Overview:
Inhibition of dynamin-mediated endocytosis such as with prochlorperazine (PCZ) has been shown to increase the efficacy of trastuzumab and other monoclonal antibodies in preclinical models. Current standard therapy for metastatic HER2-positive breast cancer is paclitaxel in combination with trastuzumab and pertuzumab, followed by continuation of HER2-directed therapy until progression. The addition of PCZ has the potential for enhanced anticancer effect, but this novel combination needs to be assessed for feasibility and safety.
Interventions:
Standard treatment with paclitaxel 80mg/m2 weekly and loading dose trastuzumab 8mg/kg and pertuzumab 840mg. From cycle 2, paclitaxel 80mg/m2 weekly, trastuzumab 6mg/kg and pertuzumab 420mg every 3 weeks in combination with de-escalating doses of PCZ given as 6 weekly treatments.
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Prochlorperazine Administration:
Prochlorperazine will be administered as an intravenous infusion at a given dose level over 20 minutes, 60 minutes following the administration of cycle 2 of the standard treatment regimen of pertuzumab, trastuzumab and paclitaxel. The reason for this is that dexamethasone, which may impact ADCC, is not required from cycle 2 of the treatment.
On completion of the prochlorperazine infusion, the intravenous line will be flushed with 100ml 0.9 normal saline. The standard reconstitution of prochlorperazine is within a solution of the mesylate salt in 5 dextrose. As the dose per infusion varies depending on body size and dose level, the concentration of the infusion will differ: for instance, an expected dose of prochlorperazine would be 50-100mg diluted in 250ml for a 1-2mg/5ml concentration solution running over 20 minutes.
Prochlorperazine is given over 6 weeks, start The primary objective is to determine the recommended phase 2 dose (RP2D), defined as the highest dose level achieved with prochlorperazine in combination with pertuzumab, trastuzumab, and paclitaxel where less than 33 patients enrolled have experienced a dose limiting toxicity (DLT).
Dose limiting toxicity assessed by the occurrence of treatment-emergent adverse events (TEAEs) graded by the Investigator per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Patients will be assessed for the presence of a DLT during their routine clinical assessments. which includes history, physical examination, and performance status, as well as at the end of their treatment and safety assessment. [Clinical assessments - Participants will be reviewed by their study investigator weekly during the prochlorperazine infusions, then every 3 weeks. Subsequent clinical assessment frequency is at the discretion of the investigator.
An end of treatment and safety assessment should be performed at 21 days after the last dose of study treatment to identify any adverse events occurring within this time. In the event of unresolved toxicity, participants should continue to be followed.] University of Queensland Female 18 Years - No limit 12 NHMRC Ideas Grant Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety; 01/03/2022 11/01/2022 05/08/2023 https://anzctr.org.au/ACTRN12622000016730.aspx Advanced/Metastatic Hospital/University/Research Institute N N N Australia Breast Breast Cancer - HER2+ Prochlorperazine Safety and/or Dose Phase 1 DB01069 N
JPRN-UMIN000004852 The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway Recruiting endometrial carcinoma Metformin (an initial dose of 750 mg/day, increased by 750 mg every week up to 1500 or 2250 mg/day) was administered to patients with endometrial cancer prior to surgery. Endometrial tissue was obtained before and during metformin therapy via endometrial biopsy for diagnosis and hysterectomy, respectively. Patients undergo blood sample collection periodically for biomarker analysis. To evaluate the effects of metformin, cell proliferation activity and signal pathway were compared between pre- and post-treatment samples. 1) Cell proliferation was evaluated by immunohistochemistry using antibody of Ki-67 (positive for all cell cycle except for G0) and topoisomerase II A(positive at S/G2/M phase) 2) Findings related to the MAPK, AMPK and mTOR signaling pathways and cell cycle proteins were compared by Western blot analysis. Graduate School of Medicine, Chiba University Female 20years-old - 70years-old 30 none Interventional Study Single arm Non-randomized 04/01/2010 11/01/2011 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005770 Localised/Locoregional Hospital/University/Research Institute N N N Japan Gynaecological Endometrial Cancer Metformin Biomarker Not available/Missing DB00703 N
JPRN-UMIN000029402 Pilot clinical study of boron neutron capture therapy on choroidal malignant melanoma Pending Treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy BNCT for patients with treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy is applied by nuclear reactor. Lithium shield should be used during neutron irradiation to protect elements in orbit from neutron exposure. Neutron irradiation time is decided to apply 1.5 x 10+E12 n/cm2 neutron as flux on retina. Local control: Skin lesion of angiosarcoma should be photographed and measured on it, periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control. Osaka Medical College All Not applicable - Not applicable 3 Osaka Medical College Interventional Study Single arm Non-randomized 10/10/2017 10/10/2017 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033598 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Skin Melanoma Lithium Response rate Phase 1/2 DB08827 N
JPRN-UMIN000029403 Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer Pending Post-radiotherapy, recurrent breast cancer BNCT for patients with post-radiotherapy, recurrent breast cancer is applied by nuclear reactor. Lithium shield should be used during neutron irradiation to protect elements in orbit from neutron exposure. Neutron irradiation time is decided to apply 1.5 x 10+E12 n/cm2 neutron as flux on skin. Local control: The lesions should be measured on MR or CT or directly on the skin periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control, based on RECIST v.1.1.. Osaka Medical College Female 20years-old - 75years-old 3 Osaka Medical College Interventional Study Single arm Non-randomized 10/10/2017 10/10/2017 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033600 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Breast Any Breast Cancer Lithium Response rate Phase 1/2 DB08827 N
JPRN-UMIN000018388 Prospective Evaluation of the Molecular Effects of Itraconazoleas an anti-cancer agent: A Window of Opportunity Study Recruiting solid tumors Following tumor tissue biopsy and collection of peripheral blood, itraconazole solution 200 mg po BID daily will be taken for 2-4 weeks. Post-treatment biopsy in cohort A and planned surgery in cohort B will be conducted. Change in Ki-67 proliferative index after 2-4 weeks of oral itraconazole solution 400 mg PO daily. Hyogo College of Medicine All 20years-old - Not applicable 20 Hyogo College of Medicine Interventional Study Single arm Non-randomized 08/10/2015 10/08/2015 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021292 Localised/Locoregional Hospital/University/Research Institute N N N Japan Multiple cancer types Any solid tumours Itraconazole Biomarker Phase 2 DB00602 N
JPRN-jRCTs011200001 Multicenter Clinical Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with Metformin Not Recruiting Rectal cancer Neoadjuvant chemoradiotherapy (capecitabine and 50.4 Gy radiation) with metformin for rectal cancer in patients without diabetes mellitus Dose-limiting toxicity (Phase I)
Pathological complete response rate considering the central pathological diagnosis (Phase II) Taketomi Akinobu All >= 20age old - < 75age old 64 Interventional Study single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose 05/08/2020 10/07/2020 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs011200001 Localised/Locoregional Hospital/University/Research Institute N N N Japan GI Rectal Cancer Metformin Safety and/or Dose; Response rate Phase 1/2 DB00703 N
CTRI/2020/03/023846 To check safety and efficacy of Naltrexone in advanced esophageal cancer. Not Yet Recruiting Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified Intervention1: Palliative chemotherapy: weekly paclitaxel 80mg/m2
Control Intervention1: Palliative chemotherapy and Naltraxone: weekly paclitaxel 80mg/m2 + naltrexone would be 0.1mg/kg body weight to a maximum dose of 5mg/day.
1. Progression Free Survival
2. Overall Survival
Timepoint: 1.PFS: At progression
2. OS: At Death Tata Memorial Hospital - - 492 Tata Memorial Hospital Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label 12/03/2020 09/03/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=41568 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India Head and Neck Laryngeal Cancer Naltrexone PFS; OS Phase 2/3 DB00788 N
CTRI/2018/02/011824 Study of Pantoprazole in a Patients with Head Neck Cancers Not Yet Recruiting Health Condition 1: null- patients who have metastatic, recurrent or locally advanced HNSCC that are unsuitable for loco-regional radical curative intent treatment and are planned for palliative chemotherapy (first-line) Intervention1: Palliative chemotherapy combined with pantoprazole: Intravenous pantoprazole (at the dose determined from the first phase of the trial) administered 30-60 minutes before chemotherapy, repeated every 21 days; combined with
Physician choice of palliative chemotherapy, which can consist of
a.Intravenous cisplatin 75 mg/m2every 21 days; or
b.OMCT: oral celecoxib 200 mg twice daily and oral methotrexate 15 mg/m2 weekly.
Control Intervention1: Palliative chemotherapy alone: Physician choice of palliative chemotherapy, which can consist of
a.Intravenous cisplatin 75 mg/m2every 21 days; or
b.OMCT: oral celecoxib 200 mg twice daily and oral methotrexate 15 mg/m2 weekly.
To find out the safe dose of intravenous pantoprazole when combined with intravenous cisplatin chemotherapy or oral metronomic chemotherapy consisting of oral daily celecoxib and weekly oral methotrexate for second phase of the studyTimepoint: At the End of phase I Tata Memorial Centre - - 140 Tata Memorial CentreTRAC DepartmentMB 3rd Floor Tata Memorial Hospital,Dr E Borges RoadParel Mumbai 400012 Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label 249;Version No 4.0 Dated 26 Dec 2017 01/03/2018 09/02/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22986 Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Pantoprazole Safety and/or Dose Phase 1/2 DB08439 N
JPRN-C000000142 PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer relapsed advanced non-small cell lung cartinoma Patients receive oral gefitinib 250mg and meloxicam 10mg once daily Response rate Department of Medical Oncology Kinki University School of Medicine All 20years-old - Not applicable 30 Department of Medical Oncology Kinki University School of Medicine Interventional Study Single arm Non-randomized 02/01/2004 08/09/2005 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000204 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Lung Non-Small Cell Lung Cancer Meloxicam Response rate Phase 2 DB01043 N
NL7496 Phase II study of oral metformin for intravesical treatment of non- muscle-invasive bladder cancer (TROJAN) Pending Non-muscle-invasive bladder cancerNMIBCBladder cancerBlaaskanker, niet-spierinvasief blaascarcinoom TURB leaving a single marker lesion followed by oral metformin treatment. Overall response: The primary outcome is the objective response rate (complete responses) after 3 months of treatment with metformin. Evaluable patients are those who have received at least 500 mg metformin twice daily for one week and who undergo a cystoscopy for marker lesion removal. Amsterdam UMC, AMC - - 49 ZonMW project 848082004 Interventional Study N/A: single arm study, Open (masking not used), N/A , unknown, Other NL7496;NL62588.018.17 02/12/2019 02/08/2019 04/03/2023 https://www.onderzoekmetmensen.nl/en/trial/25176 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands Urological Bladder Cancer Metformin Response rate Phase 2 DB00703 N
CTRI/2019/11/021924 A trial comparing maintenance with low dose oral methotrexate and propranolol versus observation after standard chemotherapy in patients with relapsed high grade epithelial ovarian cancer. Open to Recruitment Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Intervention1: Oral methotrexate and propranolol: Metronomic maintenance with oral methotrexate and propranolol versus observation after chemotherapy in relapsed platinum sensitive high grade epithelial ovarian cancer
Oral administration of the following drugs starting at least 1 month (ie 30days) after the last chemotherapy (to a maximum of 3 months) and continuing till disease progression or toxicity.
i.T. MTX 15 mg as a single dose once a week
ii.T Propranolol 20 mg BD in first week followed by 40 mg BD continuously if patient tolerates
Control Intervention1: Observation: Observation after chemotherapy in relapsed platinum sensitive high grade epithelial ovarian cancer
Progression free survivalTimepoint: Accrual Time- 36 months
Follow up time ? ??24 months
Applied for Extramural grant - - 150 Institute Tata Memorial Centre,Dr E Borges Marg,Parel,Mumbai 400012, IndiaFunding awaited Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label 01/01/2020 07/11/2019 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36645 Adjuvant/Maintenance Recurrent/Refractory Hospital/University/Research Institute Y N N India Gynaecological Ovarian Epithelial Cancer Propranolol PFS Phase 3 DB00165 N
CTRI/2021/09/036296 Oral Chemotherapy for advanced head and neck cancer. Not Yet Recruiting Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Intervention1: Triple Metronomic: TAB. Erlotinib 150mg OD
Capsule. Celecoxib 200mg BD
TAB. Methorexate 9mg/m2 weekly
Control Intervention1: Physician Choice Therapy: INJ. methotrexate or
INJ. Docetaxel or
TAB. Capecitabine
Overall survivalTimepoint: 6 Months NO - - 214 Intramural grantMahamana Pandit Madan Mohan Cancer Centre Sundarpur Varanasi Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label IEC project No. 11000506 15/09/2021 07/09/2021 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58988 Palliative Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Celecoxib OS Phase 3 DB00567 N
CTRI/2021/05/033482 it is a phase III trial where advanced pancreatic adenocarcinoma patients will be randomised in 2 arms . 1 arm includes losartan given with folfirinox chemotherapy regime and the other arm includes fofirinox chemotherapy only . Not Yet Recruiting Health Condition 1: K868- Other specified diseases of pancreas Intervention1: LOSARTAN: Arm B ?? chemotherapy alone Oxaliplatin 65mg/m2 IV over 2 hours Irinotecan 135mg/m2 IV over 90 mins Leucovorin 300mg/m2 IV over 2 hours
5 FU - 1800mg/m2 IV over 46 hours continuous infusion
Intervention2: LOSARTAN WITH FOLFIRINOX: Tablet Losartan 50 mg PO one tablet daily once at nigh plus Oxaliplatin 65mg/m2 IV over 2 hours
Irinotecan 135mg/m2 IV over 90 mins Leucovorin 300mg/m2 IV over 2 hours
5 FU - 1800mg/m2 IV over 46 hours continuous infusion
Intervention3: ONLY FOLOFIRINOX: Arm B ?? chemotherapy alone Oxaliplatin 65mg/m2 IV over 2 hours Irinotecan 135mg/m2 IV over 90 mins Leucovorin 300mg/m2 IV over 2 hours
5 FU - 1800mg/m2 IV over 46 hours continuous infusion
Control Intervention1: not applicable: not applicable
To evaluate whether the addition of a drug commonly used in control of blood pressure (Losartan) will improve survival when combined with standard chemotherapy in advanced pancreatic and periampullary cancersTimepoint: 84 months Tata Memorial Hospital - - 264 Intramural tata memorial hospital Dr ernest marg Parel Mumbai 400012 Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable 25/05/2021 07/05/2021 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54937 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N India GI Pancreatic Cancer Losartan OS Phase 3 DB00227 N
CTRI/2012/03/002483 To Evaluate the effect of Metformin versus Placebo as an Add-on Therapy in patients with recurrent epithelial ovarian cancer receiving chemotherapy: A double blind randomized controlled clinical trial. Closed to Recruitment of Participants Health Condition 1: null- Recurrent Epithelial Ovarian Cancer Intervention1: metformin: Dose - 500 mg twice daily orally
for one year
Control Intervention1: placebo(starch powder): Dose - 500 mg twice daily orally for one year
prolonging progression free survivalTimepoint: patients will be followed for 1 year and time to relapse will be noted Dr Reddys Laboratories Ltd - - 100 Dr Reddys Laboratories Ltd. Interventional Study Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded 07/03/2012 07/03/2012 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3190 Primary/Main Curative Recurrent/Refractory Company Y N N India Gynaecological Ovarian Epithelial Cancer Metformin PFS Phase 3 DB00703 N
ACTRN12621001347853 Clinical study assessing the anti-cancer activity of sulfasalazine in patients with advanced or metastatic pancreatic ductal adenocarcinoma whose cancer has worsened following therapy with current standard of care. Recruiting Pancreatic cancer;
Pancreatic cancer;Cancer - Pancreatic Participants will be commenced on treatment with sulfasalazine (500mg oral tablets) at 1.5 g per day in three evenly divided doses. The dose will be incrementally increased to the target dose (4.5 g per day in three evenly divided doses), subject to tolerability. The dose may be further escalated to 6 g per day, in three evenly divided doses, subject to no significant intolerance and study PI approval.
Participant acetylator status, which affects how quickly sulfasalazine is processed in the body, is used to inform the dose escalation schedule during the first treatment cycle. For fast acetylators, the sulfasalazine dose is expected to increase to 3g per day on Day 4, further escalated to the target dose on Day 8 and may be further escalated to 6g per day on Day 15 subject to tolerability and PI approval. For slow acetylators, the dose is expected to increase to 3g per day on Day 8, further escalated to the target dose on Day 15 and may be further escalated to 6g per day on Day 22 subject to tolerability and PI approval.
All participants will continue the study treatment until clinical or radiological progression or until treatment discontinuation criteria are met. Tablet counts will be performed by the study team to assess adherence.
To prevent low levels of folic acid that can occur with sulfasalazine treatment, participants will also take 1mg of oral folic acid tablets daily. To quantify progression-free survival (PFS) rate at 6 months among patients with pancreatic ductal adenocarcinoma treated with sulfasalazine. Disease progression is assessed by site investigators using Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 criteria using CT scans or clinical criteria based on clinical signs and symptoms. PFS is assessed by site investigators at study visits/contacts.[ 6 months from start date of study treatment] Australian Genomic Cancer Medicine Centre Ltd t/a Omico All 18 Years - No limit 38 Cancer Institute NSW Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group; 19/06/2023 07/10/2021 29/04/2024 https://anzctr.org.au/ACTRN12621001347853.aspx Advanced/Metastatic Hospital/University/Research Institute N N N Australia GI Pancreatic Cancer Sulfasalazine PFS Phase 2 DB00605 N
CTRI/2020/11/028953 Assessment of nivolumab and metronomic aspalliative Treatment in head and neck cancer patients Not Yet Recruiting Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynxHealth Condition 2: C00-D49- Neoplasms Intervention1: Nivolumab Therapy Arm: Nivolumab- Inj Nivolumab 20 mg in 100 ml NS over 60 minutes every 3 weekly will be administered with standard of care chemotherapy.
Control Intervention1: Standard of care chemotherapy: Chemotherapy will be administered with tablet erlotinib 150 mg ( fixed dose ) PO OD daily, capsule celecoxib 200 mg ( fixed dose ) PO BD daily and oral weekly methotrexate 9 mg/m2. All chemotherapy medications will be taken 1 hour before breakfast. The methotrexate is available in 2.5 mg tablets. Hence the dose of methotrexate will be rounded of to the nearest lower numerical which is a multiple of 2.5. This could enable delivery of methotrexate without the need for breaking or crushing the tablets. All methotrexate tablets will be taken together. It will be a 21 day cycle
To compare the overall survival.Timepoint: 5 years Tata Memorial Hospital - - 184 Tata Memorial Hospital Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable 900663;Version No 2.0 Dated 26th August 2020 17/11/2020 06/11/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48487 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India Head and Neck Any head and neck squamous cell carcinoma Celecoxib OS Phase 2/3 DB00567 N
TCTR20171106001 Immunomodulatory Effect of Vitamin D in Colon Cancer Patients: a Randomized Clinical Trial Pending (Not yet recruiting) Colon cancer stage 1 and 2Male or Female , aged 30 -75 yearsBeing at least 1 month after surgery No previous chemotherapy or radiotherapy
Colon cancer
Inflammatory markers
Immune markers
Vitamin D3
1 ,25(OH)2D3;Colon cancer
Inflammatory markers
Immune markers
Vitamin D3
1 ,25(OH)2D3 Randomized block design by blocking on sex with two arms (vitamin D3 VS non -vitamin D3 supplementations) will be used among 80 patients who meet inclusion and exclusion criteria. Patients in intervention group (40 patients) will receive daily 8 ,000 IU of vitamin D3 supplementation for 3 months. Then , the immunological response and vitamin D status will be observed.,Patients in conventional group (40 patients) will not receive daily 8 ,000 IU of vitamin D3 supplementation for 3 months. They just receive standard treatment care as a conventional therapy. Then , the immunological response and vitamin D status will be observed.;Experimental Dietary Supplement,No Intervention No treatment;Vitamin D receiver group,Conventional group Immunological markers 3 months Immunological and biochemical tests Chulabhorn International College of Medicine , Thammasat University All 30 Years - 75 Years 80 Chulabhorn International College of Medicine , Thammasat University Interventional Study Randomized 20/11/2017 06/11/2017 27/05/2024 https://www.thaiclinicaltrials.org/show/TCTR20171106001 Localised/Locoregional Hospital/University/Research Institute N N N Thailand GI Colon Cancer Calcipotriol; Calcitriol Biomarker Phase 2 DB00136; DB08907 N
CTRI/2012/12/003180 A study to assess safety and effectiveness of oral medicine of valproate in advanced brain tumors Open to Recruitment Health Condition 1: null- Recurrent/ Progressive brain Tumors Intervention1: Valproate/valproic Acid: Valproate is available as 200mg, 300mg and 500mg controlled release tablets which will be used in this study. The total dose will be rounded off to the nearest 100mg.
Intervention2: valproate/Valproic acid: Valproate is available as 200mg, 300mg and 500mg controlled release tablets which will be used in this study. The total dose will be rounded off to the nearest 100mg.
Intervention3: Valproate/Valproic acid.: Valproate is available as 200mg, 300mg and 500mg controlled release tablets which will be used in this study. The total dose will be rounded off to the nearest 100mg. This drug will be given orally for 6 months or till progression or unacceptable toxicity.
Control Intervention1: Not applicable: Not applicable
To assess the toxicity of oral valproic acid ( VA) administered at doses required to maintain serum trough VA concentrations of 100 to 150 g/mLTimepoint: Monitoring for toxicity will be done weekly during dose escalation phase and 4 weekly after achieving serum trough concentration of 100-150 g/mL Tata Memorial Centre - - 30 Tata Memorial Centre Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label TMC; IRB Project No : 653 03/10/2011 05/12/2012 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3390 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N India CNS Any CNS cancers Valproic Acid Safety and/or Dose Phase 1/2 DB00177 N
CTRI/2020/08/026992 A study of low intensity chemotherapy in relapsed and refractory lymphoma patients Open to Recruitment Health Condition 1: C817- Other Hodgkin lymphomaHealth Condition 2: C858- Other specified types of non-Hodgkin lymphoma Intervention1: injection paclitaxel and daily oral sodium valproate
: Tab Sodium Valproate 60mg/kg/day orally in 3 divided doses 3 days followed by 15 mg/kg/d in two divided doses from 4th day till next cycle
Inj Dexamethasone 16mg intravenous , weekly along with Paclitaxel
Inj Paclitaxel 80 mg/m2 intravenously once weekly on D4,D11,D18
Every 21 days(total of 3 cycles)
Control Intervention1: nil: nil
To assess the Overall response rates (ORR) of weekly paclitaxel and daily oral sodium valproate in patients of relapsed refractory lymphoma.Timepoint: at baseline,9 weeks and 6 months Jawaharlal Institute Post Graduate Medical Education and Research - - 84 Jawaharlal Institute Post Graduate Medical Education and ResearchDhanwantari NagarPondicherry-605006 Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label 10/08/2020 05/08/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45791 Recurrent/Refractory Hospital/University/Research Institute N N N India Lymphoma Hodgkin Lymphoma, Adult; Non-Hodgkin Lymphoma, Adult Valproic Acid Response rate Phase 2 DB00177 N
JPRN-UMIN000002577 Effect of Zoledronic acid for Stage D2 hormone-sensitive prostate cancer patients. Pending Prostate Cancer MAB (combination of LHRH agonist and non-steroidal antiandrogen) therapy until PSA refractory
MAB therapy with 4mg Zoledronic acid at every 4 weeks 1 PSA nadir rate 2 Time to PSA nadir Department of Urology, Keio University School of Medicine Male Not applicable - 85years-old 96 non Interventional Study Parallel Randomized 12/01/2009 05/10/2009 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003142 Localised/Locoregional Hospital/University/Research Institute Y N N Japan Urological Prostate Cancer Zoledronic Acid Biomarker Phase 2 N
JPRN-jRCTs071180031 Newly diagnosed elderly symptomatic multiple myeloma: phase 2 study Not Recruiting Multiple myeloma
Multiple myeloma;Multiple myeloma scVRD induction : Four 3-week cycles of scVRD. Cycle 1, subcutaneous bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11, oral Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 4, 8, 11. Cycle2-4, subcutaneous bortezomib 1.3 mg/m2 on days 1, 8 and 15, Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 8 and 15.
scBor-plerixafor-G-CSF PBSC mobilization : subcutaneous bortezomib 1.3 mg/m2 on days 1 and 4, and subcutaneous plerixafor 0.24 mg/ kg on day 4 and G-CSF 10ug/kg on day1-5 and PBSCH after day 5. The collection goal is 2.0x10^6 CD34+ cells/kg.
High dose chemotherapy and PBSCT : subcutaneous bortezomib 1.3mg/m2 on days -4,-1, 3 and 6, L-PAM 70mg/m2 on days -3, and -2, and PBSCT at day 0.
IRD consolidation : Four 4-week cycles of oral ixazomib 4mg on days 1, 8 and 15, oral lenalidomide 15 mg on days 1 through 21 of each 28-days cycle, and dexamethasone 40 mg/day on days 1, 8 and 15.
Lenalidomide maintenance : 4-week cycles of oral lenalidomide 10 mg on days 1 through 21 of each 28-days cycle until disease progression or intolerable adverse event. Complete response (CR) rates after consolidation therapy. Tanimoto Kazuki All >= 66age old - <= 75age old 49 Bristol-Myers Squibb Company;Bristol-Myers Squibb Company Interventional Study single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose UMIN000028421 28/11/2017 05/03/2019 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs071180031 Localised/Locoregional Hospital/University/Research Institute N N N Japan Other Haem-onc Multiple Myeloma Plerixafor Response rate Phase 2 Not found in DrugBank N
CTRI/2019/09/021060 Effect of addition of zoledronic acid to chemotherapy in improving the response of tumor before surgery, in women with breast cancer (triple negative subtype) Not Yet Recruiting Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C50- Malignant neoplasm of breast Intervention1: Zoledronic acid: Addition of Zoledronic acid to standard of care neoadjuvant chemotherapy
Inj. Zoledronic acid 4mg in 100ml saline given intravenously over 30 min - every 21 days
Control Intervention1: NIL: NIL
Pathological complete response rate of 42 percentTimepoint: 6 months Intramural fund of JIPMER - - 107 Intra-mural Funding Committee, Jawaharlal institute of postgraduate medical education and research, puducherry Interventional Study Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 11/09/2019 04/09/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=35887 Localised/Locoregional Hospital/University/Research Institute N N N India Breast Breast Cancer - TNBC Zoledronic Acid Response rate Phase 2 N
CTRI/2017/08/009265 Role of Nelfinavir during chemoradiation for Cervical Cancer Open to Recruitment Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Intervention1: Nelfinavir Arm: If patient is randomized to nelfinavir arm then nelfinavir will be started at the dose of 1250 mg bid 5-7 days prior standard treatment which consist of concurrent chemoradiation and brachytherapy.
Control Intervention1: Standard Arm: If patient is randomized to standard arm patient will receive concurrent chemoradiation and brachytherapy.
? Improvement in disease free survival at 3 years, by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy).Timepoint: 3 years Tata Memorial Centre and Varian International - - 348 DAE-CTC, CRS Department, 3rd Floor, Main Building, Tata Memorial Hospital, Parel, Mumbai-400012;Varian Medical Systems Foundation,3100 Hansen Way, M/S E-190 , Palo Alto, CA 94304 Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label 16/01/2018 04/08/2017 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18147 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N India Gynaecological Cervical Cancer Nelfinavir DFS/RFS/EFS Phase 3 DB00622 N
JPRN-UMIN000021750 A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia / lymphoma Complete: follow-up continuing Adult T-cell leukemia/lymphoma VZV vaccine
Combination chemotherapy including Mogamulizumab Whether VZV vaccine inoculation can induce anti-HTLV-I specific CTL or not? Japanese Red Cross Nagasaki Genbaku Hospital All 20years-old - Not applicable 10 The Research Foundation for Microbial Diseases of Osaka University Interventional Study Parallel Non-randomized jRCTs051180107 25/04/2016 04/04/2016 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025084 Localised/Locoregional Hospital/University/Research Institute Y N N Japan Leukemia; Lymphoma Any lymphoma Varicella vaccine Safety and/or Dose; Biomarker Phase 2 DB00661 N
JPRN-UMIN000020856 Exploratory study on the anti-proliferative effects of metformin on endometrial cancer Complete: follow-up continuing Endometrial cancer 1)Patients will receive a daily dose of metformin (initial dose, 500 mg/day; increased weekly up to 2250 mg/day in the absence of any adverse effects). 2)Metformin will be administered in patients who fulfill the eligibility criteria. Metfomin will be administrated in patients until a day prior to the operation. 3)Endometrial biopsy samples will be obtained before metformin administration (as baseline) and during operation. To evaluate the effect of metformin on H19 expression in endometrial cancer tissue Ciba University Female 20years-old - 60years-old 15 the Japan Society for Promotion of Science. Interventional Study Single arm Non-randomized 02/04/2016 04/02/2016 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024069 Any/All Stages Hospital/University/Research Institute N N N Japan Gynaecological Endometrial Cancer Metformin Biomarker Phase 2 DB00703 N
JPRN-UMIN000016438 A feasibility study of the metronomic chemotherapy using oral tegafur-uracil and cyclophosphamide for recurrent gynecological cancers Recruiting advance and recurrent gynecological cancer UFT,cyclophosphamide,celecoxib Safety Disease Control Rate Saitama Medical University International Medical Center Female 20years-old - Not applicable 30 Saitama Medical University International Medical Center Interventional Study Single arm Non-randomized 03/01/2013 04/02/2015 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019089 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Gynaecological Endometrial Cancer; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Ovarian - Other; Primary Peritoneal Cancer; Fallopian Tube Cancer Celecoxib Safety and/or Dose; Other (specify) Not available/Missing DB00567 N
CTRI/2020/11/028826 Effects of Anaesthesia On Immune Suppression, Inflammation AND Metastasis Of Breast Cancer. Closed to Recruitment of Participants Health Condition 1: C50- Malignant neoplasm of breast Intervention1: Propofol TIVA: Maintenance of anaesthesia will be done using target controlled infusion of propofol, using Schnieder model for effect site concentration, along with endotracheal intubation and controlled ventilation.
Control Intervention1: Volatile Anaesthetic.: Maintenance of anaesthesia will be done using volatile inhaled anaesthetics namely isoflurane, nitrous oxide (1-1.3 MAC) along with endotracheal intubation and controlled ventilation.
Frequency and activity of NK cellsTimepoint: 1. Intra-operatively after 1 hour of incision.
2. 48 hours post-operatively Chittaranjan National Cancer Institute - - 40 Chittaranjan National Cancer Institute,37, SP Mukherjee Road,Kolkata, 700026 Interventional Study Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded 18/11/2020 03/11/2020 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48408 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Propofol Biomarker Not available/Missing DB00571 N
CTRI/2017/02/007777 Study of chemotherapy treatment after completion of standard treatment Not Yet Recruiting Health Condition 1: null- Patients with locally advanced oral cancers post surgery and appropriate adjuvant treatment Intervention1: In arm B adjuvant metronomic would be administered.: Metronomic chemotherapy is the study intervention in this trial. The metronomic chemotherapy constitutes of methotrexate and celecoxib.
Oral methotrexate tablet 15 mg/m2 will be administered weekly ie on D1,D8, D15 and D22 of every 28 day cycle.
Capsule celecoxib would will be self administered twice daily in a dose of 200 mg BID continuously .
The combination will be continued to a maximum of Such 18 cycles; unless prohibitive toxicity or disease progression occurs prior. will be delivered.
Control Intervention1: In arm Aobservation would be done. The schedule of observation will be in accordance with the institutional follow up protocol
: In arm Aobservation would be done. The schedule of observation will be in accordance with the institutional follow up protocol is as below
First year : Patient would be followed up at 3 monthly intervals. Clinical history and examination would be done. Blood investigations like complete hemogram, renal function tests and TSH would be done. FACT QOL H N would be filled at baseline and at 6 months
Second year : Patient would be followed up at 4 monthly intervals. Clinical history and examination would be done. Blood investigations like complete hemogram, renal function tests and TSH would be done sos.
Third year-Fifth year : Patient would be followed up at 6 monthly intervals. Clinical history and examination would be done. Blood investigations like complete hemogram, renal function tests and TSH would be done sos.
Post fifth year : Patient would be followed up at 1 year intervals. Clinical history and examination would be done. Blood investigations like complete hemogram, renal function tests and TSH would be done SOS.
1.2 year OS : OS will be defined time in days between date of randomization to date of death. Patients alive at their last follow ups would be censored. The 2 year OS would be estimated by Kaplan meier analysis and would be compared between the 2 arms by the log rank testTimepoint: at two year post treatment Tata Memorial Hospital - - 712 Tata Memorial HospitalDr. E. Borges Road, Parel (east)Mumbai Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Other Blinding and masking:Not Applicable Protocol No 1708 Version 1.0 dated 16 June 2016 03/02/2017 03/02/2017 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16667 Localised/Locoregional Hospital/University/Research Institute N N N India Head and Neck Any head and neck squamous cell carcinoma Celecoxib OS Not available/Missing DB00567 N
ACTRN12621000223831 Efficacy of assigning treatment for participants with Chronic Myelomonocytic Leukaemia based on their individual molecular results (lenzilumab plus azacitidine versus sodium ascorbate plus azacitidine). Recruiting Chronic Myelomonocytic Leukaemia;
Chronic Myelomonocytic Leukaemia;Cancer - Leukaemia - Chronic leukaemia This prospective study will assess whether treatment responses for participants with Chronic Myelomonocytic Leukaemia can be improved by targeting certain mutation sub-groups based on individual molecular profiling.
As part of the screening process, participants will be required to have a bone marrow aspirate and trephine. During this procedure, 9 mL of bone marrow aspirate will be collected for central mutation profiling which is a test used to detect certain acquired mutations that can be present in CMML. The most common genes affected in CMML include TET2 and a group of genes belonging to the RAS pathway (NRAS/KRAS/CBL). Both TET2 and RAS pathway genes contribute to CMML, but the way in which they work is different. As a result, we need to tailor our medications specifically to switch them off. Before participants are enrolled in this research study, we will need to assess whether either of these groups of genes have been affected in their case. If they are, the participant may be eligible for this study. Genetic testing is complex and it will take approximately 3 weeks for results to become available.
Participants with RAS pathway mutations in will receive lenzilumab in combination with azacitidine, while patients with TET2 mutations will receive sodium ascorbate plus azacitidine. Participants who are found to have both TET2 and RAS pathway mutations (NRAS/KRAS/CBL) will be allocated to the lenzilumab/azacitidine arm of the study. Participants who are negative for both TET2 and NRAS/KRAS/CBL mutations (Variant Allele Frequency [VAF] >= 3 ) at screening will be considered screen failures.
Drug schedules:
Lenzilumab/Azacitidine Arm (total of 24 Cycles). Each Cycle is 28 days.
€ Azacitidine (subcutaneous) 75 mg/m2 on days 1-5, To assess the frequency of complete response (CR) and partial response (PR) at any point during the first 12 cycles of active therapy according to Savona Criteria. (composite outcome)[ Any point during the first 12 cycles] South Australian Health Medical Research Institute Ltd All 18 Years - No limit 72 Medical Research Future Fund Grant, National Health and Medical Research Council. Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Parallel;Type of endpoint: Efficacy; 28/09/2021 03/03/2021 13/11/2023 https://anzctr.org.au/ACTRN12621000223831.aspx Localised/Locoregional Hospital/University/Research Institute N N N Australia Leukemia Chronic Myelogenous Leukemia Ascorbic acid Response rate Phase 2 DB00335 N
CTRI/2019/01/016837 Comparision of two types of chemotherapy regimen in head and neck cancer Not Yet Recruiting Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Intervention1: Triple Metronomic: Chemotherapy will be administered with tablet erlotinib 150 mg ( fixed dose ) PO OD daily, capsule celecoxib 200 mg ( fixed dose ) PO BD daily and oral weekly methotrexate 9 mg/m2. Schedule will be repeated at 4 weekly intervals. Intervention will be till progression or intolerable side effects.
Intervention2: Docetaxel: Docetaxel will be administered (75 mg/m2) on day 1 in 3 weekly cycles.
Docetaxel will be administered till progression or intolerable side effects.
Control Intervention1: Best Supportive Care: Patient will receive supportive treatment.
1.Analgesic for pain
2.Antibiotics and dressing for fungating wounds
3.Nutritional support :ryle tube insertion, enteral supplementations
4.Antitussive for cough
5.Physiotherapy and exercises for trismus
6.Distress counselling if present by physicians
7.Others : symptomatic treated directed towards symptoms
Phase II
1.Disease control rate
Phase III
1.Over all survival
Phase III
1.Over all survival
Timepoint: Phase II
1.6 weeks
Phase III
1.6 months
Tata Memorial Hospital - - 455 Tata Memorial Hospital Interventional Study Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:On-site computer system Blinding and masking:Open Label 11/02/2019 02/01/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=28826 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N India Head and Neck Any head and neck cancer Celecoxib OS; DFS/RFS/EFS Phase 2/3 DB00567 N
JPRN-UMIN000002435 Assessment of a combination therapy with Candesartan and Celecoxib for patients with advanced hepatocellular carcinoma after transhepatic arterial chemoembolization. Recruiting unresectable advanced hepatocellular carcinoma Celecoxib and Candesartan
plasebo Time to progression Kurume University, School of Medicine,Department of Medicine, Division of Gastroenterology All 20years-old - Not applicable 80 Kurume University, School of Medicine,Department of Medicine, Division of Gastroenterology Interventional Study Parallel Randomized 09/01/2008 02/09/2009 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002980 Advanced/Metastatic Hospital/University/Research Institute Y N N Japan GI Liver Cancer Candesartan; Celecoxib Other (specify) Phase 2 DB09061; DB00567 N
CTRI/2018/03/012274 A clinical trial to study the effects of two drugs, Curcumin and Metformin in patients with history of head and neck squamous cell cancers Open to Recruitment Health Condition 1: null- Patients who have had curative intent treatment for head and neck squamous cell carcinoma Intervention1: Curcumin Capsule: 1.2 gm once daily oral for 36 months
Intervention2: Metformin Tablet: 1 gm once daily oral for 36 months
Control Intervention1: Curcumin Placebo: 1.2 gm once daily oral for 36 months
Control Intervention2: Metformin Placebo: 1 gm once daily oral for 36 months
To determine the efficacy of curcumin and metformin to reduce the incidence of second primary tumors of aero-digestive tract following curative intent treatment of head and neck squamous cell carcinomasTimepoint: Every 3 months upto the incidence of second primary tumor National Cancer Grid - - 1500 National Cancer Grid (Department of Atomic Energy, Government of India),Room No 1231,12th Floor,Homi Bhabha Block,Tata Memorial Centre,Dr E Borges Road,Parel,Mumbai 400012 Interventional Study Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Double Blind Double Dummy 02/04/2018 01/03/2018 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21431 Other (specify) Local/National government Y N N India Head and Neck Any head and neck squamous cell carcinoma Metformin Recurrence rate Phase 2/3 DB00703 N
CTRI/2019/02/017394 Pioglitazone study in Blood cancer Not Yet Recruiting Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive Intervention1: Pioglitazone tablets: Intervention is Tab.Pioglitazone and the comparator agent is Placebo. Both arms will receive Tab.Imatinib at 400 mg od, the standard of care. Pioglitazone will be started at 30 mg od and will be given for 2 months. Subsequently, if tolerated, the dose will be increased to 45 mg od. This will be given for another 10 months, for a total of 12 months.
Control Intervention1: Placebo: Comparator agent is Placebo. Both arms will receive Tab.Imatinib at 400 mg od, the standard of care. Pioglitazone will be started at 30 mg od and will be given for 2 months. Subsequently, if tolerated, the dose will be increased to 45 mg od. This will be given for another 10 months, for a total of 12 months.
Proportion of patients achieving Major Molecular Response (MMR) at 12 monthsTimepoint: Proportion of patients achieving Major Molecular Response (MMR) at 12 months Christian Medical College Vellore - - 82 Institution funded study - Academic study Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded 04/02/2019 01/02/2019 24/11/2021 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=30395 Localised/Locoregional Hospital/University/Research Institute Y N N India Leukemia Chronic Myelogenous Leukemia Pioglitazone Response rate Not available/Missing DB04951 N
TCTR20190701001 Phase II, Multi-Center, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Mycophenolate Mofetil in Patients with High-Grade Locally Advanced or Metastatic Osteosarcoma (ESMMO) Recruiting High-grade locally advanced or metastatic osteosarcoma
Osteosarcoma;Osteosarcoma Mycophenolate mofetil is normally used for the prophylaxis of organ rejection following transplantation.;Experimental Drug;Mycophenolate mofetil Progression -free survival at 16 weeks CT/MRI Faculty of Medicine, Chiang Mai University All 13 Years - N/A (No limit) 27 National Science and Technology Development Agency (NSTDA) Interventional Study ESMMO-2019 01/08/2019 01/07/2019 27/05/2024 https://www.thaiclinicaltrials.org/show/TCTR20190701001 Advanced/Metastatic Hospital/University/Research Institute N N Y Thailand Bone Sarcoma Osteosarcoma Mycophenolate PFS Phase 2 DB08813 N
JPRN-UMIN000027795 The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer. Pending castration resistant prostate cancer Patients is treated with abiraterone (1,000 mg daily) and prednisone (5 mg daily) for two 4-week cycles. After this time, dutasteride (0.5 mg daily) is added for 12 weeks. Patients continue on the three-drug regimen until study withdrawal or radiographic disease progression. the rate of patients with over fifty percent reduction in PSA Department od Urology, Yamaguchi Graduate School of Medicine Male 50years-old - 90years-old 20 Grant-in-Aid for Scientific Research Interventional Study Single arm Non-randomized 08/01/2017 01/07/2017 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029208 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Urological Prostate Cancer Dutasteride Biomarker Phase 2 DB11742 N
JPRN-UMIN000031532 Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III) Recruiting Stage III colorectal cancer A:Placebo. Patients in this group receive placebo for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
B:Aspirin. Patients in this group receive aspirin, at a dose of 100 mg for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine). Disease-free survival Japan Clinical Oncology Group (JCOG) All 20years-old - 80years-old 880 Japan Agency for Medical Research and Development Interventional Study Parallel Randomized 30/03/2018 01/03/2018 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035650 Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N Japan GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 3 DB01048 N
JPRN-UMIN000003261 Randomized controlled trial comparing zoledronic acid plus chemotherapy with chemotherapy alone as a neoadjuvant treatment in patients with primary breast cancer Recruiting Breast Cancer FEC100 (500/100/500 mg/m2) every 21 days for 4 cycles followed by weekly Paclitaxel 80 for 12 cycles (or weekly Paclitaxel 80 followed by FEC100).
Patients receive zoledronic acid 4mg or an adjusted dose used renal function IV over 15 minutes infusion every 3-4 weeks for 6 months ( 6-7 times infusion). Pathological complete response rate:pCR JONIE Study Group Female 20years-old - 70years-old 180 None Interventional Study Parallel Randomized 03/01/2010 01/03/2010 17/10/2023 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003949 Localised/Locoregional Collaborative Group Y N N Japan Breast Any Breast Cancer Zoledronic Acid Response rate Phase 2 N
JPRN-jRCTs031200326 A phase I/II study of maintenance therapy with metformin and temozolomide for newly diagnosed glioblastoma patients Recruiting Glioblastoma 1) Concomitant phase,
metformin (level1 , everyday) 7days
2) Maintenance phase, metformin and temozolomide
temozolomide (150mg/m2, day1-5, every 4 weeks) and metformin (level3 , everyday) 1 cycle
temozolomide (150mg/m2, day1-5, every 4 weeks) and metformin (level3 , everyday) 5 cycles
3) Metformin alone
metformin (level3 , everyday) 365days Phase I:Dose limiting toxicity (DLT) occurrence rate,Phase II:12-month progression-free survival rate Narita Yoshitaka All >= 20age old - < 75age old 22 Japan Agency for Medical Research and Development Interventional Study single arm study, open(masking not used), active control, single assignment, treatment purpose 01/11/2020 01/02/2021 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs031200326 Localised/Locoregional Hospital/University/Research Institute N N N Japan CNS Glioblastoma Metformin Safety and/or Dose; PFS Phase 1/2 DB00703 N
ChiCTR2100049941 Clinical project of new chemotherapy regiments for glioblastoma multiform (GBM) Pending glioblastoma multiform Two groups:TMZ combined with levetiracetam chemotherapy; patient survival; the Second Affiliated Hospital of Chongqing Medical University All 18 - 65 Two groups:142; Chongqing joint medical scientific research project, the National Nature Science Foundation of People's Republic of China (81401500), Science Foundation of Chongqing (X0231), the High-level Medical Re Interventional Study Parallel 30/11/2021 14/08/2021 19/04/2022 http://www.chictr.org.cn/showproj.aspx?proj=131815 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute Y N N China CNS Glioblastoma Levetiracetam OS Not available/Missing DB01137 N
ChiCTR2100049694 Effect of Lidocaine on CD4 + / CD8 + T cells and body stress in patients undergoing gastric cancer surgery Pending N/A Experimental group:Intravenous Lidocaine;Control group:Intravenous physiological saline; CD4+T cell;CD8+T cell;tumor recurrence rate; First Affiliated Hospital of Soochow University All - Experimental group:50;Control group:50; National Natural Science Foundation of China (grant number 81873925), Jiangsu Provincial Medical Youth Talent (grant number QNRC2016741) Interventional Study Parallel 08/10/2021 08/08/2021 19/04/2022 http://www.chictr.org.cn/showproj.aspx?proj=131704 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Gastric Cancer Lidocaine Biomarker Phase 2 DB08882 N
IRCT20210703051770N1 Evaluation and comparison of treatment regimens in patients with acute leukemia. Recruiting Acute T cell leukemia.
Adult T-cell lymphoma/leukemia (HTLV-1-associated);C91.5 Intervention 1: Intervention group: In the intervention group, the Hyper CVAD drug regimen is performed in alternating cycles A and B. Cycle A: Cyclophosphamide 300 mg / m2 every 12 hours on days 1, 2, and 3. Vincristine 2 mg / m2 on days 4 and 11. Adriamycin (doxorubicin) 50 mg / m2 on day 4 Dexamethasone 40 mg on days 1, 4, 11, 12, 13 and 14. Methotrexate 12.5 mg with dexamethasone 4 mg intrathecally on day 2. Cycle B: Methotrexate 1 g / m2 on day 1. Cytosar 3 g / m2 every 12 hours on days 2 and 3. Intrathecal methotrexate on day 2. Cyclophosphamide (importer of Sina Pishgam Drug New), Wayne Christine (importer of Valian Drug), Adriamycin (Behestan Drug Company), Vial of methotrexate (Kavosh Daro Gostar Co.), Interferon (Aktor and Sinagen Co.). Intervention 2: Control group: Intravenous arsenic 10 mg daily for 5 days a week. Subcutaneous interferon 5 million units per day. Zidovudine 900 mg daily in 3 doses. Complete Remission. Timepoint: Weekly from before the intervention (beginning of the study) to 60 days after the intervention. Method of measurement: Based on complete response to treatment (Achieving remission or not getting remission) Through chemical tests and CBC.;One-year survival. Timepoint: On a daily basis from before the intervention (beginning of the study) to 60 days after the intervention. Method of measurement: Based on the individuals' survival rate (Calculate the number of days to survive until death) Through the occurrence of death in two groups. Mashhad University of Medical Sciences All 18 years - no limit 36 Mashhad University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: This type of randomization will be done using the site https://www.sealedenvelope.com. In this method, the volume of each block must first be determined. Then, a list of the blocks are prepared and numbers are assigned to each (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)). In the next step, random numbers from 1 to 6 are selected (e.g. 1 4 5, etc.) and finally, the treatment allocation list is specified based on the previous random numbers (AABB-BBAA-BABA- € ), Blinding description: In this study, participants are blinded to the intervention received based on codes (codes A and B) that people are unaware of the type of intervention received and only researchers are aware of it. Also, the drugs are the same in shape, color and coating to allow blindness at the participant level. 25/03/2022 29/04/2022 05/02/2022 http://en.irct.ir/trial/61873 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Leukemia Leukemia - Other Zidovudine Response rate Phase 2 DB00744 N
IRCT20220409054463N1 Metformin as a chemotherapeutic agent Pending Endometrial carcinoma.
Malignant neoplasm of endometrium;C54.1 Intervention 1: Intervention group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. For each volunteer a form containing basic personal information and demographic information including age, BMI at the time of admission and day of surgery, pregnancy and parity, underlying disease, smoking, menopause, date of first diagnosis And the suggested time for surgery is filled. Patients with the above criteria, after filling out the form related to the initial information, an endometrial sample prepared by pipelle biopsy or curettage will be sent to the pathology department of Imam Hossein Hospital for examination and staining of ki-67 and p-53. And is examined by one pathologist. Patients are given a box of 100 metformin 500 tablets. Explanations about how to take the drug, its side effects, including gastrointestinal symptoms and symptoms of hypoglycemia, etc., and a contact number to communicate with patients participating in the project will be given to the patient by the medical team. All patients will receive treatment according to standard guidelines, and metformin will be discontinued 48 hours before anesthesia to prevent the risk of lactic acidosis. Intervention 2: Control group: In this study, we intend to refer patients with endometrial cancer who have been referred to Mahdieh / Imam Hossein (AS) Hospital, and are on the list of gynecological surgeries of this hospital, regardless of histological and surgical staging, for at least 4 weeks. Metformin 500 mg tablets are given orally every 8 hours. F Changes in the expression of ki-67 gene in tissue samples of endometrial cancer after using metformin. Timepoint: Before treatment and on the day of surgery. Method of measurement: Ki-67 tissue staining (IHC).;Determining the effect of metformin use in reducing body mass index. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measuring Body Mass Index (weight over height^2).;Determining the effect of metformin on tumor size reduction. Timepoint: Before treatment and on the day of surgery. Method of measurement: Measurement of mass during diagnosis by ultrasound and by the surgeon.;Changes in p-53 gene expression in endometrial cancer tissue samples after metformin use. Timepoint: Before treatment and on the day of surgery. Method of measurement: P-53 tissue staining (IHC). Shahid Beheshti University of Medical Sciences Female 20 years - no limit 40 Shahid Beheshti University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization, using the Rand function of Excel software, Blinding description: The study is double-blind, and the patient, caregiver, and researcher do not know which category the patient is in (metformin or placebo). 21/06/2022 27/04/2022 05/02/2022 http://en.irct.ir/trial/63034 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Gynaecological Endometrial Cancer Metformin Response rate; Biomarker Phase 1/2 DB00703 N
ChiCTR2100050796 Effects of lidocaine and dexmedetomidine on perioperative tumor metastasis markers and inflammatory markers in patients undergoing thoracoscopic lung cancer resection Recruiting lung cancer Control group:Intravenous pumping 0.9 NS;Lidocaine group:Intravenous pumping lidocaine;Dexmedetomidine group:Intravenous pumping dexmedetomidine;Lidocaine combined with dexmedetomidine group:Intravenous pumping lidocaine and dexmedetomidine; Myeloperoxidase (MPO), a specific index of neutrophils extracellular trapping net in serum ; Affiliated Hospital of Xuzhou Medical University All 18 - 70 Control group:33;Lidocaine group:33;Dexmedetomidine group:33;Lidocaine combined with dexmedetomidine group:33; Talent introduction of scientific research start-up funds Interventional Study Parallel 21/07/2022 09/04/2021 23/08/2022 http://www.chictr.org.cn/showproj.aspx?proj=133132 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Any lung cancers Lidocaine Biomarker Phase 2 DB08882 N
DRKS00028966 Evaluation of the effect of total intravenous and inhalation anesthesia on tumor growth Recruiting
C25
C18
C22;Malignant neoplasm of pancreas;Malignant neoplasm of colon;Malignant neoplasm of liver and intrahepatic bile ducts Group 1: Inhalation anesthesia
Patients receive Thiopental for the initiation and sevoflurane as maintanance anesthesia.
Both arms contain standard anesthesia protocols - none of them is experimental.
Group 2: Injection anesthesia
Patients receive propofol anesthesia The primary study endpoint is the size of subcutaneous metastases in a nude mouse model from single cell suspensions from resected tumor specimen. Allgemein-, Viszeral- u. Transplantationschirurgie Universit tsmedizin Mainz All 18 Years - None 80 Universit tsmedizin der Johannes Gutenberg-Universit t Mainz Interventional Study Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: basic science 02/05/2022 20/05/2022 27/05/2024 http://drks.de/search/en/trial/DRKS00028966 Localised/Locoregional Hospital/University/Research Institute Y N N Germany GI Cholangiocaricnoma; Colon Cancer; Liver Cancer; Pancreatic Cancer; Rectal Cancer Propofol Other (specify) Phase 2 DB00571 N
CTRI/2022/05/042576 Metformin with chemotherapy in Triple negative and Her2neu positive breastcancer - a randomisedstudy Open to Recruitment Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Intervention1: Metformin with standard Neo-Adjuvant chemotherapy: Tab Metformin - 850mg PO twice daily for 18-22 weeks
Control Intervention1: standard Neo-adjuvant chemotherapy: standard Neo-adjuvant chemotherapy
the pathological complete response rates(ypT0ypN0) in each arm.Timepoint: 18-22 weeks All India Institute of Medical Sciences - - 242 All India Institute of Medical Sciences, New Delhi Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label 21/05/2022 17/05/2022 21/08/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=68786 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Breast Cancer - TNBC; Breast Cancer - HER2+ Metformin Response rate Phase 2 DB00703 N
JPRN-jRCTs041220024 A Phase 1 study of Fasudil with MAP targeting cancer stem cell. Pending High grade osteosarcoma fasudil hydrochloride hydrate as an IV infusion;fasudil hydrochloride hydrate Dose limiting toxicity
Maximum tolerated dose Fujita Nobuyuki All >= 14age old - < 65age old 18 Interventional Study single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose 31/05/2022 31/05/2022 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs041220024 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N Japan Bone Sarcoma Osteosarcoma Fasudil Safety and/or Dose Phase 1 DB01023 N
ACTRN12622001201763 Targeting the Renin-Angiotensin System in Glioblastoma (TRAS-GB) Trial Not yet recruiting Glioblastoma;
Glioblastoma;Cancer - Brain Study medication is introduced in a step-wise manner, starting 4 weeks after completion of surgery and radiotherapy and the first cycle of chemotherapy (Temozolomide (TMZ)).
The study treatment consists of six oral medications. The dosage of the medications is increased over a 4 week period, and the treatment is maintained for the duration of the study. The total duration of the study is 4 years.
The dosing regime is as follows;
1) Propranolol; week 0 - 40mg twice daily, week 1 - 80mg morning, 40mg evening, continue at this dose for the remainder of the study
2) Aliskiren; week 0 - 150mg once daily, continue at this dose for the remainder of the study
3) Curcumin with piperine; week 0 - 1000mg twice daily, continue at this dose for the remainder of the study
4) Celecoxib; introduced at week 4 - 200mg once daily, continue at this dose for the remainder of the study
5) Metformin; week 0 - 250mg once daily, week 1 - 250mg twice daily, week 3 - 500mg morning, 250mg evening, week 4 - 500mg twice daily, continue at this dose for the remainder of the study
6) Quinapril; introduced at week 2 - 5mg once daily, week 3 - 10mg once daily, week 4 - 20mg once daily, continue at this dose for the remainder of the study
Renal function, platelet count, blood pressure and pulse rate are monitored. Overall median survival from diagnosis[Assessed on an ongoing basis for study duration. The study is planned for a 4 year duration.] Gillies McIndoe Research Institute All 16 Years - 80 Years 75 Gillies McIndoe Research Institute Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;Type of endpoint: Efficacy; 01/02/2023 07/09/2022 09/12/2022 https://anzctr.org.au/ACTRN12622001201763.aspx Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N New Zealand CNS Glioblastoma Aliskiren; Celecoxib; Metformin; Propranolol OS Phase 2 DB00437; DB00567; DB00703; DB00165 N
ChiCTR2100053537 An exploratory study on the synergistic effect of simultaneous hepatic arterial infusion of sodium bicarbonate injection in the treatment of hepatocellular carcinoma with anti-PD-1 monoclonal antibody Recruiting Hepatocellular carcinoma Treatment group:hepatic artery catheterization and infusion of 5 sodium bicarbonate injection; Liver-enhanced MRI lesion necrosis; The Second Affiliated Hospital, Zhejiang University School of Medicine All 18 - Treatment group:30; self-funded Interventional Study Single arm 30/11/2021 24/11/2021 10/04/2022 http://www.chictr.org.cn/showproj.aspx?proj=140967 Localised/Locoregional Hospital/University/Research Institute N N N China GI Liver Cancer Sodium Bicarbonate Other (specify) Not available/Missing DB00421 N
CTRI/2022/08/045109 Clinical trial of metformin and valproic acid combination in lung cancer Not Yet Recruiting Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lung Intervention1: T.Metformin 1000 mg BD
T.Valproate 20 mg/kg/day
for 9 weeks in addition to chemotherapy: Metformin 1000 mg BD and Valprate 20 mg/kg/day adjusted to a target plasma concentration of 50-100 mcg/dL according to previous clinical trials and in vitro studies are given for 9 weeks in ad-dition to chemotherapy
Control Intervention1: NIL: NIL
Overall Response Rate by using RECIST 1.1 criteriaTimepoint: 9 weeks JIPMER Intramural fund - - 52 JIPMER Intramural Resarch FundJIPMER,Puducherry 605006 Interventional Study Single Arm Study
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable JIP/IEC/2022/58 01/09/2022 31/08/2022 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=72422 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N India Lung Non-Small Cell Lung Cancer Metformin; Valproic Acid Response rate Phase 2 DB00703; DB00177 N
CTRI/2022/08/044794 Metformin as Chemo-sensitizer in Ovarian Malignancies Not Yet Recruiting Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Intervention1: Metformin HCL: Patients will receive Metformin HCL orally 500mg twice daily (BD) and standard chemotherapy regimen for 3-4 cycles in neo-adjuvant settings (Total Duration 3 months)
Control Intervention1: Placebo: Patients will receive Placebo orally BD and standard chemotherapy for 3-4 cycles neoadjuvantly. (Total duration 3 months)
Chemotherapy Response Score (CRS) and its correlation with Clinico-radiological response with CECT using RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)Timepoint: Chemotherapy Response Score (CRS) and its correlation with Clinico-radiological response with CECT using RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) will be done at 4-6 weeks post completion of neo-adjuvant chemotherapy Indian Council of Medical Research - - 62 Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India;JN Medical College, Aligarh Muslim University, Aligarh, U.P-202002 Interventional Study Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded 01/11/2022 22/08/2022 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=68406 Neo-adjuvant/Window Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India Gynaecological Fallopian Tube Cancer; Ovarian Epithelial Cancer; Primary Peritoneal Cancer Metformin Response rate Phase 3 DB00703 N
CTRI/2022/10/046252 Investigate the effect of Propranolol and Celecoxib combine with Receptor activator of nuclear factor kappa- ? ?? ligand (RANKL) blockade therapy during the perioperative period of Osteosarcoma (Bone cancer) patients. Not Yet Recruiting Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified Intervention1: Perioperative therapy and Denosumab with OGS-12 protocol chemotherapy: The regimen comprises of oral tablet propranolol 20 mg BD for first 10 days followed by 40
mg BD thereafter and Tab Celecoxib 200mg BD and these will be started on Day 8 of last
cycle of pre-operative chemotherapy and continued until 24 hours prior to surgery.A single dose of injection Denosumab 120 mg s/c will be administered during the first week
of perioperative therapy before surgery. Propranolol and Celecoxib will be restarted once oral
feeds have been started post-surgery. Both Propranolol and Celecoxib will be stopped when
patient has been started on adjuvant chemotherapy cycles as per the ? ?OGS-12 ? ? protocol. The
expected duration of the use of above drugs in the perioperative period is around 6-8 weeks.Participants randomized to this arm will be treated according to the ? ?OGS-12 ? ? based
chemotherapy alone as described above.
Control Intervention1: OGS-12 protocol chemotherapy: It is an in-house standard chemotherapy protocol for high grade osteosarcomas and consists
of dose dense, sequential doublets of cisplatinum, adriamycin and ifosfamide in four cycles
of neoadjuvant therapy(NACT) and four cycles of (cisplatinum and ifosfamide) as adjuvant
chemotherapy (ACT) delivered every 21 days.
2-year Event-free survival (EFS) rate - EFS will be measured from the date of
randomization to the date of progression or death.
3-year Overall Survival (OS) rate ? ?? OS will be measured from the date of
randomization to the date of death.Timepoint: Event- free survival (EFS) rate - 2 year
Overall Survival (OS) rate - 3 year Tata Memorial Hospital - - 86 Nil Interventional Study Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label 07/11/2022 07/10/2022 17/10/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=73414 Localised/Locoregional Hospital/University/Research Institute Y N Y India Bone Sarcoma Osteosarcoma Celecoxib; Propranolol OS; DFS/RFS/EFS Phase 2 DB00567; DB00165 N
RBR-76j763k Vitamin K3 treatment in Stomach Cancer patients in a public hospital Recruiting Malignant neoplasm of cardia; Malignant neoplasm of the fundus of the stomach; Malignant neoplasm of the body of the stomach; Malignant neoplasm of the pyloric antrum; Malignant neoplasm of the pylorus; Malignant neoplasm of stomach with invasive lesion This is a two-arm, double-blind, randomized controlled clinical trial. A total of 160 patients who meet the eligibility criteria will be probabilistically allocated to one or the other intervention group using a table of random numbers. Patients received perioperative chemotherapy, that is, before and after surgery, and will be randomly assigned in a 1:1 ratio to two experimental groups, the first (80 patients regardless of gender) that will receive treatment based on 5-Fluorouracil (5-FU ) and the second (80 patients with the same gender distribution as the first group) who will receive 5-FU and menadione. Both the researchers who will assess the outcomes and the participants will not know to which group each participant belongs. Neoadjuvant treatment (before surgery) consisted of four cycles of two weeks (8 weeks). Patients must be operated on within 28 days of completing the fourth course of treatment. After recovery from the surgical procedure, patients who have not progressed previously will be treated with four additional cycles of adjuvant chemotherapy (after surgery) at the same doses and intervals as neoadjuvant treatment. Thirty days after the end of the last cycle of treatment, an appointment will be held and patients will be referred for routine care. Patients will be followed up for 24 months after resection. The following regimen will be administered to patients in the FLOT group on the first day of the cycle: a) Docetaxel, for two hours of intravenous infusion, at 50 mg/m2; b) Oxaliplatin, for two hours of intravenous infusion, at 85 mg/m2 in 500 ml of 5 glucose; c) Leucovorin, for one hour of intravenous infusion, at 200 mg/m2 in 250 ml of 0.9 sodium chloride; d)5-FU, for 24 hours of intravenous infusion, at 2600 mg/m2. The administration of these four;D02.455.426.559.847.638.721.374.922 A partial or complete response is expected to be found in at least 50 of patients Hospital Ophir Loyola - 19Y - 0 Conselho Nacional de Desenvolvimento Cient fico e Tecnol gico Interventional Study 01/02/2022 09/11/2022 29/05/2023 http://ensaiosclinicos.gov.br/rg/RBR-76j763k Localised/Locoregional Hospital/University/Research Institute Y N N Brazil GI Gastric Cancer Menadione Response rate Phase 2 DB12148 N
CTRI/2022/11/046961 A study to compare the effect of different types of anaesthesia on blood inflammatory markers in gynaecological cancer patients. Not Yet Recruiting Health Condition 1: C56- Malignant neoplasm of ovary Intervention1: TIVA (total intravenous anaesthesia): propofol will be used for anaesthesia maintenance
Control Intervention1: Inhalational anesthesia: inhalation anaesthetic agent for anaesthesia maintenance, with minimal alveolar concentration of 1.
??To compare difference in change of post-operative and preoperative NLR (Day 3-preoperative) in both the groups.Timepoint: day 3 All India Institute of Medical Sciences Jodhpur - - 82 All India Institute of Medical Sciences, Basni Phase II , Jodhpur, Rajasthan Interventional Study Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable AIIMS/IEC/2022/3994 07/11/2022 01/11/2022 21/11/2022 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=67924 Localised/Locoregional Hospital/University/Research Institute Y N N India Gynaecological Any gynaecological cancers Propofol Biomarker Phase 1 DB00571 N
ChiCTR2100054650 A phase II clinical study evaluating the efficacy and safety of Fruquintinib combined with azithromycin liposome in patients with Platinum resistant ovarian cancer Pending Ovarian cancer Experimental group:Fruquintinib combined with azithromycin liposome; Pathological complete response rate; Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Female 18 - 75 Experimental group:41; None Interventional Study Single arm 23/12/2021 23/12/2021 28/11/2022 http://www.chictr.org.cn/showproj.aspx?proj=144938 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China Gynaecological Ovarian Epithelial Cancer Azithromycin Response rate Phase 4 DB06401 N
CTRI/2023/01/049248 A study to see the effectives of a parasitic drug called Mebendazole when given with chemotherapy CCNU in patients. Open to Recruitment Health Condition 1: C719- Malignant neoplasm of brain, unspecified Intervention1: CCNU regimen plus Mebendazole: 1. Tablet pantoprazole 40 mg- Early morning empty stomach.
2. Mebendazole tablets would be chewed with breakfast (800 mg)- Breakfast for the entire cycle of 42 days.
3. Tablet Granisetron 1 mg or ondansetron 8 mg-1 hours post breakfast.
4. Capsule CCNU ( 110 mg/m2)- 2 hours post breakfast only on day 1 of the 42 days cycle
5. Mebendazole tablets would be chewed with lunch (800 mg)-Lunch for the entire cycle of 42 days.
6. Mebendazole tablets would be chewed with dinner (800 mg)-dinner for the entire cycle of 42 days.
Control Intervention1: CCNU regimen: CCNU will be given only on day 1 of the 42 days cycle. Rest of the drugs are routinely given as per the standard of care.
To compare the overall survival (OS) between the two arms.Timepoint: OS will be calculated in time in months between the date of randomization to the date of death. Patients alive at their last follow ups will also be censored.
Cancer Research and Statistics Foundation CRSF - - 182 Cancer Research and Statistics Foundation (CRSF);Krishna Institute of Medical Sciences;Post Graduate Institute of Medical Education Research;Ramaiah Medical College;Tata Memorial Hospital Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable 01/02/2023 27/01/2023 16/10/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=69127 Palliative Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N India CNS Glioma Mebendazole OS Phase 3 DB00737 N
CTRI/2023/02/049406 A study comparing two chemotherapy regimens prior to surgery for patients with technically unresectable oral cancers Open to Recruitment Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified Intervention1: TPF regimen: Inj Docetaxel 75 mg/m2 in 500 ml NS intravenous over 1 hour on Day 1
Inj Cisplatin 75 mg/m2 in 500 ml NS over 1 hour on Day 1
Inj 5 FU 750 mg/m2 in 500 ml NS over 24 hours
Control Intervention1: Paclitaxel carboplatin and oral metronomic chemotherapy: Patients will receive Paclitaxel (80 mg/m2) plus Carboplatin (AUC 1.5) on day 1 in weekly
cycles. In addition they will receive a fixed dose of celecoxib 200 mg PO BD, erlotinib 150 mg
PO OD and methotrexate 9 mg/m2 weekly. (All chemotherapy medications will be taken 1 hour
before breakfast. The methotrexate is in 2.5 mg tablets. Hence the dose of methotrexate will be
rounded off to the nearest lower numerical which is a multiple of 2.5. This could enable delivery
of methotrexate without the need for breaking or crushing the tablets. All methotrexate tablets
will be taken together. It will be a 21 day cycle.)
Overall SurvivalTimepoint: OS will be assessed as time in months from the
date of randomization to the date of death. Patients
alive at their last follow-ups will also be censored. None - - 332 Vedant HospitalKasarvadavli, Ghodbunder Road, Pin code: 400 615 Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable 15/02/2023 02/02/2023 29/05/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=78701 Localised/Locoregional Hospital/University/Research Institute Y N N India Head and Neck Other Head and Neck Celecoxib OS Phase 3 DB00567 N
ChiCTR2200057842 Metformin and omeprazole induce enhanced high-dose vitamin C in the treatment of advanced malignant tumors Recruiting Advanced malignant tumors Study Group:Vitamin C injection;Study Group:Omeprazole injection;Study Group:metformin; Disease control rate; The First Affiliated Hospital of Sun Yat-Sen University All 18 - Study Group:36;Study Group:36;Study Group:36; National Key Research and Development Program Interventional Study Sequential 14/03/2022 19/03/2022 13/11/2023 https://www.chictr.org.cn/showproj.html?proj=160117 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China Multiple cancer types Any solid tumours Ascorbic acid; Metformin; Omeprazole Other (specify) Not available/Missing DB00335; DB00703; DB01083 N
CTRI/2023/02/049751 A STUDY ON METFORMIN AND CHEMOTHERAPY COMBINATION IN NON-DIABETES MELLITUS PATIENTS FOR BREAST CANCER Open to Recruitment Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Intervention1: METFORMIN AND NEOADJUVANT OR PALLIATIVE CHEMOTHERAPY: 4-8 cycles of neoadjuvant chemotherapy or palliative chemotherapy will be given for all group of patients. Each cycle as a duration of 3 weeks where you have treatment on the 1st and 8th days, but nothing on days 2 to 7 and days 9 to 21.
Intervention group will receive metformin 1500 mg per day along with chemotherapy or palliative chemotherapy.
Control Intervention1: PLACEBO AND NEOADJUVANT OR PALLIATIVE CHEMOTHERAPY: 4-8 cycles of neoadjuvant chemotherapy or palliative chemotherapy will be given for all group of patients. Each cycle as a duration of 3 weeks where you have treatment on the 1st and 8th days, but nothing on days 2 to 7 and days 9 to 21.
Standard group will receive placebo along with chemotherapy or palliative chemotherapy.
Improvement in reduction of tumor size and numbers.
Reduction in side effects and adverse events of chemo drugs.
Non chemo drugs also can be used in the treatment of breast cancer.
Timepoint: baseline
3rd month
6th month SRM COLLEGE OF PHARMACY - - 70 SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,SRM INSTITUTE OF SCIENCE AND TECHNOLOGY,KATTANKULATHUR-603203 Interventional Study Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded 20/02/2023 15/02/2023 03/06/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=78523 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Metformin Response rate Not available/Missing DB00703 N
CTRI/2023/02/049523 Study of Losartan and Standard of care therapy in advanced biliary tract cancer Not Yet Recruiting Health Condition 1: C23- Malignant neoplasm of gallbladder Intervention1: Tab Losartan Drug: Tab Losartan medication given to all gall bladder carcinoma patient as per inclusion criteria
Intervention2: no controlled grou[: not applicable
Intervention3: tab Losartan: initially started with with 25mg OD dose per oral and gradually increase up to 100 mg depend on patient vitlas for a period of 9 month
Control Intervention1: tab losartan: Not applicable
Control Intervention2: NIL: NIL
main aim of the study is repurposing of drug - That is tab losartan will increase the penetration of chemotherapy drugs into the tumors cell effectively - measured by increase the survival of patient for more than 9 month ( normally chemotherapy had survival of 6 month duration) in a sample size of 25 patient and the study will end after 9 months
Timepoint: initially at the time of starting chemotherapy then on 3rd month ( after completing 3 cycle chemotherapy ) and 6th month after competing 6th chemotherapy, then onwards Every 3 months patients will be analyzed for events
INHS ASVINI - - 24 Study is conducted in INHS Asvini. Tab losartan will supplied by central drug store in INHS Asvini for free of cost Interventional Study Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label 13/02/2023 07/02/2023 03/06/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77170 Advanced/Metastatic Hospital/University/Research Institute N N N India GI Cholangiocaricnoma Losartan OS Phase 2 DB00227 N
ChiCTR2200061789 Fasudil hydrochloride in the treatment of gene-specific ovarian cancer patients Pending Ovary cancer first group:Fasudil Hydrochloride Injection;second group:Standard chemotherapy agent and placebo; Number of treatment courses received;Overall survival;progression free survival;objective response rate;complete remission;partial remission; Tianjin Medical University General Hospital Female - first group:50;second group:50; Tianjin Medical University General Hospital Interventional Study Case-Control study 08/01/2022 07/02/2022 04/03/2023 http://www.chictr.org.cn/showproj.aspx?proj=173662 Localised/Locoregional; Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Gynaecological Ovarian Epithelial Cancer Fasudil PFS; OS Not available/Missing DB01023 N
ChiCTR2200066615 The effect of intraoperative intravenous lidocaine infusion on short-term recovery and long-term prognosis of patients with lung cancer: a prospective, randomized, controlled clinical trial Pending Lung cancer Lidocaine group:Intraoperative intravenous lidocaine infusion;Control goup:Intraoperative intravenous normal saline infusion; Overall survival;Disease free survival; Zhongshan Hospital, Fudan University All - Lidocaine group:386;Control goup:386; Major clinical research project of Shenkang Hospital Development Center Interventional Study Parallel 12/01/2022 12/12/2022 15/05/2023 https://www.chictr.org.cn/showproj.html?proj=186787 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Any lung cancers Lidocaine OS; DFS/RFS/EFS Not available/Missing DB08882 N
ChiCTR2200065595 Exploratory Clinical Study on Mifepristone for the Treatment of Recurrent Glioblastoma Pending Recurrent Glioblastoma treatment group:Administration of Mifepristone; complete blood count;liver function test;kidney function test;endocrine test;contrast-enhanced brain MR; Huashan Hospital, Fudan University All 18 - treatment group:20; Self Funding Interventional Study Single arm 21/11/2022 11/09/2022 15/05/2023 https://www.chictr.org.cn/showproj.html?proj=174280 Recurrent/Refractory Hospital/University/Research Institute N N N China CNS Glioblastoma Mifepristone Biomarker Not available/Missing DB09031 N
ChiCTR2300068631 Oral aminophylline combined with sunitinib malate capsule in the treatment of locally advanced unresectable renal clear cell carcinoma or distant metastasis: a prospective, open, single-arm, multicenter exploratory study Recruiting locally advanced unresectable renal clear cell carcinoma or distant metastasis Test group:Aminophylline combined with sunitinib malate capsule was taken orally; Progression-free survival; Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine All 18 - 70 Test group:22; Shanghai Sixth People's Hospital Jieqing Cultivation Fund Interventional Study Single arm 03/01/2023 26/02/2023 22/05/2023 https://www.chictr.org.cn/showproj.html?proj=184453 Localised/Locoregional Hospital/University/Research Institute N N N China Urological Renal Cell Carcinoma Aminophylline PFS Not available/Missing DB01118 N
ChiCTR2300068563 lidocaine Effects on neutrophil extracellular trapping and angiogenesis biomarkers in postoperative breast cancer patients with different anesthesia methods Pending breast cancer Sevoflurane anesthesia experimental group:lidocaine;The control group was anesthetized with sevoflurane:saline;Propofol-TIVA anesthesia experimental group:lidocaine ;The control group was anesthetized with propofol-TIVA:saline; MPO;H3Cit;NE;MMP-9;VEGF-A; General Hospital of Ningxia Medical University Female 18 - 70 Sevoflurane anesthesia experimental group:30;The control group was anesthetized with sevoflurane:30;Propofol-TIVA anesthesia experimental group:30;The control group was anesthetized with propofol-TIVA:30; Department of Science and Technology of Ningxia Hui Autonomous Region Interventional Study Parallel 23/02/2023 23/02/2023 22/05/2023 https://www.chictr.org.cn/showproj.html?proj=187911 Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Lidocaine Biomarker Not available/Missing DB08882 N
CTRI/2023/05/052737 effect of addition of Aspirin in oral cancer survival Not Yet Recruiting Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Intervention1: Aspirin: Aspirin 150 mg PO daily in addition to standard of care till toxicity or recurrence
Control Intervention1: Standard of care: Standard of care as per guidelines based on the TNM stage i.e. Surgery, Surgery with Radiotherapy or palliative chemotherapy of investigators choice
safety and toxicity as per WHO toxicity criteria and adverse event monitoringTimepoint: Every 3 weeks Banaras Hindu University - - 60 Banaras Hindu University, Varanasi, India Interventional Study Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant Blinded 26/05/2023 17/05/2023 29/05/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=85165 Any/All Stages Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Acetylsalicylic Acid Safety and/or Dose Phase 2/3 DB01048 N
ISRCTN81939514 Indolent prostate cancer, phytochemicals and probiotics Ongoing Indolent prostate cancer
Cancer This is a double-blind, randomised, controlled trial in men who have a diagnosis of indolent prostate cancer managed with surveillance alone. Following written informed consent, patients will be randomised (1:1) to:
€ Men in one randomised arm (blinded) will receive a phytochemical-rich food supplement (PFS) containing whole dried pomegranate, turmeric, green tea, broccoli, cranberry and ginger plus a probiotic capsule containing a blend of 10 billion colony-forming units (CFU) of 5 lactobacilli plus inulin and low dose cholecalciferol as prebiotics.
€ Men in the other blinded randomised group will be given the PFS plus placebo
Each capsule will be taken twice a day, for 4 months. Participants are asked to stop all other over-the-counter supplements
The phytochemical-rich capsule contains dried whole foods which have previously been reported as safe among men with prostate cancer in prospective studies. The ingredients of both supplements have been shown to have a high safety profile. This blend has been used in two previous studies and was safe and well-tolerated.
Computer generated Block Randomisation will be employed. A spreadsheet will be created; in column 1, sequential participant numbers will be recorded. In column 2, block-generated randomised Arms (A or B), will be recorded. After a participant has consented they will be allocated the next trial number and randomised Arm in strict order. Participants will be given a four-month supply of either A or B plus the whole food supplement.
Contact will be face-to-face consultations with the medical team at baseline and at trial termination during their routine clinical management for surveillance. Location: Primrose Oncology Research Unit within the Oncology department of Bedford Hospital, Bedfordshire Hospitals Prostatic specific antigen doubling time (PSAdt) measured using a routine blood test analysis at trial entry baseline and 4 months Bedford Hospital NHS Trust Male - 180 Bedford Hospital Research Fund Interventional Study Randomized double-blind controlled study (Safety, Efficacy) Nil known;Nil known;IRAS 321309 01/08/2023 19/06/2023 30/10/2023 https://www.isrctn.com/ISRCTN81939514 Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom Urological Prostate Cancer Cholecalciferol Biomarker Other Not found in DrugBank N
CTRI/2023/05/053195 Define role of chronomodulation in Gemcitabinne chemotherapy Not Yet Recruiting Health Condition 1: C23- Malignant neoplasm of gallbladder Intervention1: melatonin: In 2 groups of study 2, 20 mg Melatonin will be administered to patients receiving chemotherapy for 14 days starting from chemotherapy cycle 1 day 8.
Control Intervention1: none: There is no comparator of melatonin in this study as this is a cross over trial.
To evaluate effect of chrono-modulation on cytidine deaminase enzyme (CDA) activity in metastatic cancer patients on Gemcitabine chemotherapy
To determine the effect of chrono-modulation on elimination
kinetics of chrono-modulated Gemcitabine chemotherapy in
metastatic cancer patients
To determine the role of melatonin on elimination kinetics of chrono-
modulated Gemcitabine chemotherapy in metastatic cancer patientsTimepoint: BASELINE CDA, CT1D1, CT2D8, CT2D1, CT2D8
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH - - 14 All India Institute of Medical Sciences Rishikesh Interventional Study Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label 10/06/2023 29/05/2023 26/06/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=70292 Advanced/Metastatic Hospital/University/Research Institute Y N N India GI Cholangiocaricnoma Melatonin Biomarker Phase 2 DB00814 N
IRCT20230315057722N1 Effect of pentoxifylline in multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation (ASCT) Recruiting Multiple myeloma (MM) patients undergoing autologous hematopoietic stem cell transplantation.
Multiple myeloma;C90.0 Intervention 1: Intervention group: Pentoxifylline group: Patients who underwent autologous transplantation receive Pentoxifylline 800 mg/d, orally as 2 divided daily doses, respectively from day +15 through day +98 post-transplant. Intervention 2: Control group: Multiple myeloma patients undergoing autologous transplantation who do not receive any intervention. Regulatory T cell. Timepoint: Days +14 and +99 post-autologous transplantation. Method of measurement: Number of T regulatory cells (CD4, CD25, FOXP3) in peripheral blood mononuclear cells (PBMC) by using flow cytometry technique. Shahid Beheshti University of Medical Sciences All 21 years - 70 years 30 - Interventional Study Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Random sequence generation: Patients were assigned in groups according to the random allocation rule. Based on the size of the research sample, we prepared 30 cards on which the PTXF and control groups were recorded and placed these cards in a lottery container. Then the cards are randomly removed from the container without replacement, and the created sequence is recorded. 2. Allocation concealment: The sequentially numbered, opaque, sealed envelope (SNOSE) method is used to perform randomization. Based on the sample size of the research, several envelopes were prepared with aluminum wrappers, and each of the random sequences created on a card was recorded and the cards were placed in the envelopes of the letter, respectively. To maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the l 15/05/2023 14/06/2023 26/06/2023 http://en.irct.ir/trial/69164 Other (specify) Hospital/University/Research Institute Y N N Israel Other Haem-onc Multiple Myeloma Pentoxifylline Biomarker Phase 2 DB08883 N
CTRI/2023/07/055019 EFFECT OF INTRAVENOUS LOCAL ANAESTHETIC AND REGIONAL BLOCK ON LEVELS OF MARKERS OF RECURRENCE IN PATIENTS UNDERGOING SURGERY FOR BREAST CANCER Not Yet Recruiting Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: O- Medical and Surgical Intervention1: Intravenous Lidocaine: given in dose of 2mg/kg bolus followed by maintenance 2mg/kg/hr infusion throughout surgery-
duration of drug infusion will be total duration of surgery
bolus will only be given once at the beginning of surgery
Control Intervention1: Erector spinae plane block: 1 lidocaine 2mg/kg bolus through catheter in the erector spinae plane followed by 1 lidocaine 2mg/kg/hr infusion throughout surgery
-duration of drug infusion will be throughout total duration of surgery, bolus will only be given once at the time of catheter placement
Comparison of biomarkers predicting metastasis and recurrence in breast cancer patients undergoing total mastectomy ?? MMP2 ,MMP9 in patients receiving IV lidocaine and erector spinae blockTimepoint: preoperatively and 36 hours postoperatively samples shall be collected AIIMS, Rishikesh - - 70 Research cell, third floor, AIIMS,Virbhadra marg, Rishikesh-249203 Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded 15/07/2023 10/07/2023 25/07/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=82649 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Any Breast Cancer Lidocaine Biomarker Phase 2 DB08882 N
ChiCTR2300074309 To explore the safety and efficacy of atorvastatin in combination with chemotherapy versus chemotherapy in patients with extensive small-cell lung cancer resistant to first-line standard therapy: a randomized controlled Phase III trial Recruiting small cell lung cancer group A:Atorvastatin+Irinotecan;group B:Irinotecan; safety;Overall survival,OS; The First Affiliated Hospital of Wenzhou Medical University All 18 - 75 group A:110;group B:110; Qilu Pharmaceutical Co. LTD Interventional Study Parallel 08/10/2023 08/03/2023 08/07/2023 https://www.chictr.org.cn/showproj.html?proj=195072 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Small Cell Lung Cancer Atorvastatin Safety and/or Dose Phase 3 DB01117 N
IRCT20230627058596N1 Effect of Atorvastatin Usage on Patients with Oral squamous cell carcinoma Pending Oral squamous cell carcinoma.
Malignant neoplasm of mouth, unspecified;C06.9 Intervention 1: Intervention group: Surgery combined with radiotherapy and Atorvastatin, 40 mg pill, C33H35FN2O5, daily, for 3 months, swallowing with water. Intervention 2: Control group: Surgery combined with radiotherapy. Superoxide dismutase marker in the saliva. Timepoint: At the beginning of the study and 3 months after taking the drug. Method of measurement: The variable measurement (Superoxide Dismutase marker) in saliva is performed by spectrophotometry method in the laboratory.;Angiogenesis Factors in the Saliva. Timepoint: At the beginning of the study and 3 months after taking the drug. Method of measurement: The measurement of variables (Angiogenesis Factors) in saliva is carried out using the spectrophotometry method in the laboratory. Karaj University of Medical Sciences All no limit - no limit 30 Faculty of Dentistry, Alborz University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Considering the sample size of 15 patients in each group, in order to randomize the samples, we write the words Users of Atorvastatin and Control on two pieces of paper and place them in a container. Then, we randomly select one of the two pieces of paper. The word chosen will determine whether the first patient after surgery is allocated to the Users of Atorvastatin group or the Control group. The second patient will be allocated to the next group (i.e., patients 1, 3, 5, etc., will be in the Users of Atorvastatin group, while patients 2, 4, 6, etc., will be in the Control group). This process will continue until all 15 samples are completed in each group. Additionally, due to the surgeon's lack of preference and choice regarding which patient receives the medication, the drug will be prescribed entirely randomly. Moreover, ne 23/08/2023 08/09/2023 21/08/2023 http://en.irct.ir/trial/70954 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Head and Neck Any head and neck squamous cell carcinoma Atorvastatin Biomarker Phase 3 DB01117 N
ChiCTR2300074442 ParecoxibNA can modulate tumor microenvironment and inhibit cell proliferation, metastasis in non-small cell lung cancer Pending non-small cell lung cancer experimental group:experimental group was injected with corresponding amount of parecoxibNA by body weight;control group:experimental group was injected with corresponding amount of saline by body weight; NRS Score; He € nan Provincial People's Hospital All 18 - 70 experimental group:160;control group:160; Self-funding Interventional Study Parallel 09/02/2023 08/07/2023 21/08/2023 https://www.chictr.org.cn/showproj.html?proj=197521 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Parecoxib Biomarker Not available/Missing DB00910 N
IRCT20230221057485N1 The effect of adding Desloratadine to neoadjuvant chemotherapy in patients with breast cancer Recruiting Breast cancer.
Malignant neoplasm of breast Intervention 1: Intervention group: 52 patients with breast cancer are randomly included in the intervention group. In addition to the neoadjuvant chemotherapy process, desloratadine 5mg (Neotadine tablets manufactured by Abidi Company, Iran) is prescribed daily (oral) until the patient is re-examined (about 2 months). At the end of 4 chemotherapy courses (every two weeks), breast ultrasound is performed again to evaluate the treatment response. then blood samples (7-10 cc) are taken and the amount of cytokines and gene expression changes in peripheral blood mononuclear cells are measured. Intervention 2: Control group: Control group: 52 patients with breast cancer are randomly included in the control group, this group is subjected to neoadjuvant chemotherapy (anthracyline base drugs) and prescribed until the patient s re-examination (about 2 months). At the end of 4 courses of chemotherapy (every two weeks), breast ultrasound is performed again to evaluate the treatment response, blood samples of the patients at the beginning and at the end of the study (2 months after the start of the treatment course) were taken in the amount of 7-10 cc and the amount cytokines and gene expression changes are measured in peripheral blood mononuclear cells. Response rate to treatment based on changes in tumor size and lymph node involvement. Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: RECIST criteria.;The serum level of tumor serological markers (CEA, CA15-3). Timepoint: At the beginning of the study and 2 months after the start of the first course of chemotherapy. Method of measurement: ELISA method. Gorgan University of Medical Sciences Female 18 years - no limit 104 Gorgan University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in a stratified manner. In this way, 34 people will be selected from among the qualified people in each of the classes. Then, by a simple random method (34 similar cards are prepared and the letter A is written on 17 cards and the letter B is written on the other 17 cards, and then the patients will be randomly assigned to groups.), Blinding description: Participants (patients) who do not know their group type, control or intervention. 08/01/2023 30/07/2023 21/08/2023 http://en.irct.ir/trial/71555 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Breast Any Breast Cancer Desloratadine Response rate Phase 2 DB00035 N
KCT0008659 Randomized phase II study of chemoimmunotherapy with or without metformin as a first-line treatment in patients with squamous cell lung carcinoma Recruiting ;Neoplasms Drug : This clinical trial will be conducted in patients with advanced squamous epithelial lung cancer to evaluate the effectiveness and safety of standard immuno-chemotherapy and metformin combination therapy.
Registered study subjects are stratified according to a predetermined stratification factor and randomly assigned to the experimental group and the control group at a ratio of 1:1.
The study subjects receive pembrolizumab or pembrolizumab and paclitaxel and carboplatin combination therapy depending on the expression of Day 1 and PD-L1 every three weeks. It is stopped when the disease progresses or an unacceptable toxicity or death occurs.
The experimental group will be continuously administered with Metformin twice a day orally.
? a method of treatment
1) PD-L1 expression is 50 or higher
Injected intravenously with pembrolizumab 200mg on Day 1. It is repeated every three weeks and lasts up to 24 months of total administration period, until the disease progresses, or until unacceptable toxicity or death occurs.
2) PD-L1 expression below 50
Intravenously injected with pembrolizumab 200mg, paclitaxel 175mg/m2, and carboplatin AUC=5 on Day 1. Repeat every three weeks until the fourth. Afterwards, pembrolizumab 200mg was repeated every 3 weeks. The administration period lasts up to 24 months, until the disease progresses, or until unacceptable toxicity or death occurs. When drug-resistant problems are expected, it can proceed to paclitaxel 75mg/m2, carboplatin AUC=3, Day 1, and Day 8.
From Cycle 1 and Day 1, take 500mg BID every day. Take 1,000mg daily with BID from Cycle2 when there is no drug resistance issue. The administration of Metformin lasts up to 24 months, until the disease progress 6 month progression free survival rate National Cancer Center All 19(Year) - No Limit 70 National Cancer Center Interventional Study Primary Purpose : Supportive Care, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT 31/10/2023 28/07/2023 03/04/2024 https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=26736 Advanced/Metastatic Hospital/University/Research Institute Y N N Korea, Republic of Lung Non-Small Cell Lung Cancer Metformin PFS Phase 2 DB00703 N
JPRN-jRCT2080222349 A Phase 1, Open-Label, Multi-center Study to Assess the Safety and Tolerability of AZD6244 (Selumetinib, ARRY142886) in Combination With Cisplatin/Gemcitabine in Japanese Patients With Inoperable Locally Advanced or Metastatic Biliary Tract Cancer (BTC) Inoperable Locally Advanced or Metastatic Biliary Tract Cancer investigational material(s)
Generic name etc : Cisplatin, Gemcitabine, Selumetinib(AZD6244)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Cisplatin:day1 and day8 at each cycle, Gemcitabine:day1 and day8 at each cycle, Selumetinib(AZD6244):25mg/day, 50mg/day and 75mg/day AstraZeneca All >= 20age old - Not applicable Interventional Study Non-Randomized, Safety Study, Single Group Assignment, Open Label JapicCTI-132399 24/12/2013 24/12/2013 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCT2080222349 Advanced/Metastatic; Recurrent/Refractory Company N N N Japan GI Cholangiocaricnoma Selumetinib Safety and/or Dose Phase 1 DB01104 N
JPRN-jRCTs021230005 A randomized phase 2 study assessing the efficacy and safety of levofloxacin added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer(T-CORE2201) Recruiting pancretic cancer Levofloxacin treatment is added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer. Progression free survival Ishioka Chikashi All >= 20age old - < 80age old 140 Tohoku Clinical Oncology Research and Education Society(T-CORE) Interventional Study randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose 19/05/2023 19/05/2023 17/10/2023 https://jrct.niph.go.jp/latest-detail/jRCTs021230005 Advanced/Metastatic Hospital/University/Research Institute Y N N Japan GI Pancreatic Cancer Levofloxacin PFS Phase 2 DB00367 N
CTIS2022-500599-79-00 Treatment with Xeljanz in a population of patients with cutaneous T cell lymphoma Not Recruiting Mycosis Fungoides;Therapeutic area: Diseases [C] - Immune System Diseases [C20]-Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]-Diseases [C] - Skin and Connective Tissue Diseases [C17] Product Name: XELJANZ 10 mg film-coated tablets,Product Code: PRD6483620,Pharmaceutical Form: FILM-COATED TABLET,Other descriptive name: ,Strength: Tofacitinib 10mg Main Objective:Does treatment with Xeljanz decrease disease activity?;Secondary Objective:;Primary end point(s): € To evaluate complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and the overall response rate to treatment with Xeljanz. Aarhus University Hospital Female 18 - 65+ 15 Interventional Study Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: 0 08/07/2022 22/04/2022 27/05/2024 https://euclinicaltrials.eu/app/#/view/2022-500599-79-00?lang=en Any/All Stages Hospital/University/Research Institute N N N Denmark Lymphoma Cutaneous T-Cell Lymphoma Tofacitinib Response rate Phase 1 DB09216 N
CTIS2022-500745-24-00 Phase II Dutasteride in combination with CAB vs CAB in SDC (DUCT) Not Recruiting Salivary Duct Carcinoma;Therapeutic area: Diseases [C] - Neoplasms [C04] Product Name: Zoladex-10,8, implantatiestaafje 10,8 mg,Product Code: PRD396274,Pharmaceutical Form: IMPLANT,Other descriptive name: ,Strength: Goserelin Acetate 10.8mg,Product Name: Casodex-50, filmomhulde tabletten 50 mg,Product Code: PRD8720588,Pharmaceutical Form: FILM-COATED TABLET,Other descriptive name: ,Strength: Bicalutamide 50mg,Product Name: Avodart 0,5 mg zachte capsules,Product Code: PRD326105,Pharmaceutical Form: CAPSULE, SOFT,Other descriptive name: ,Strength: Dutasteride 0.5mg Main Objective:To determine the efficacy of dutasteride in combination with combined androgen blockade therapy in patients with recurrent and/or metastatic salivary duct carcinoma;Secondary Objective:To assess other indicators of therapy efficacy,To assess the safety profile of dutasteride when combined with combined androgen blockade therapy,To assess the quality of life of patients treated with dutasteride in combination to combined androgen blockade therapy,To explore predictive markers of response,To assess the expression of molecular targets and to document the modulation of response in the tumor microenvironment;Primary end point(s):Overall response rate (ORR) defined as proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by Investigator according to RECIST v1.1,Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first Stichting Radboud University Medical Center Female 18 - 65+ 98 Radboudumc;ZonMw Interventional Study Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: 2 11/08/2022 09/06/2022 27/05/2024 https://euclinicaltrials.eu/app/#/view/2022-500745-24-00?lang=en Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Netherlands Head and Neck Salivary Gland Cancer Dutasteride Response rate Phase 2 DB11742 N
ChiCTR2300074976 A single-arm clinical trial to evaluate the efficacy and safety of Simvastatin, Orlistat, and Trimetazidine in combination with second-line treatment drugs for advanced liver cancer Recruiting Liver cancer Group of liver cancer :Patients with advanced liver cancer received Simvastatin 20mg po qn, Orlistat 120mg po tid, Trimetazidine 20mg po tid combined with second-line treatment drugs for advanced liver cancer; Objective Response Rate(ORR); Affiliated Hospital of Qingdao University All 18 - 99 Group of liver cancer :43; Self-funding for scientific research Interventional Study Single arm 27/12/2023 22/08/2023 01/08/2024 https://www.chictr.org.cn/showproj.html?proj=205420 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China GI Liver Cancer Orlistat; Simvastatin Response rate Phase 4 DB13310; DB00877 N
ChiCTR2300076126 PET-guided high-dose vitamin C synergised with 131I, 177Lu-DOTA-TATE, 177Lu-PSMA for advanced thyroid cancer, neuroendocrine tumours, and prostate cancer Pending advanced thyroid cancer, neuroendocrine tumours, and prostate cancer Experimental group:1) PET/CT examination: 18F-FDG, 18F-FAA PET/CT imaging
2) 131I, 177Lu-DOTA-TATE, 177Lu-PSMA internal irradiation routine treatment
3) Intravenous and/or intratumoral vitamin C injections; Objective Response Rate; The First Affiliated Hospital of Sun Yat-Sen University All 18 - Experimental group:110; Clinical specialty capacity building support program Interventional Study Single arm 27/09/2023 25/09/2023 10/03/2023 https://www.chictr.org.cn/showproj.html?proj=207774 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China Endocrine; Urological Thyroid Cancer; Neuroendocrine Tumours; Prostate Cancer Ascorbic acid Response rate Phase 2 DB00335 N
ACTRN12623001164684 Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for cancer: The ReDO cancer treatment study Not yet recruiting Cancer;
Cancer;Cancer - Any cancer The REDO Protocol consists of 19 medication (a) and nutrients (b) , introduced one item at the time, each item 3 days apart with side effects monitored over a period of 2 months. The full ReDO protocol (19 items) consists of the following dosages per day administered for 3 months (90 days).
All items are administered as oral tablets, with the exception of item 19, which is provided as oil.
Order of items in 2 month introduction period / Item / Dosage per day:
a) Prescription medication
1Dichloroacetate500 mg x2
2Propanolol40mg x 2
3Metformin500 mg x 1; 500 mg x 2
4Atorvastatin (+ CoQ10)20 mg/ night; 2x 20 mg
7Sodium Phenylbutyrate1-4 g/ night
8Dipyridamole2x 100 mg/ day; 2x200 mg
9Hydroxychloroquine 200 mg /night
10Ivermectin25 mg/night
11Melatonin100mg
12Doxycycline50 mg x2
13Mebendazole / Fenbendazole100 mg x2
17Loratadine (Anti-histamine)20 mg x 2
b) Natural herbal supplements
5Genistein100mg x 3
6D-Mannose2x 1000 mg
14Vitamin A (Retinoic Acid)35,000 IU - 1 week on 1 week off
15Berberine2x 500mg
16Epigallocatechin Gallate (EGCG) = green tea extract400 mg x2
18Hydroxy-citrate (Garcinia cambogia)1000 mg x 2
19Nigella Sativa Black Seed Oil5ml x2
Compliance will be monitored by an online participant diary app.
Circulating Tumour Cell (CTC) count in CTC/ml[blood test using the validated Cytology-based Isolation-by-SizE-of-Tumour (ISET) - CTC system (Rarecells), which consists of two steps, a0 the isolation of cancer cells by filtration from 10ml of blood, and b) microscopy to count the number of CTC per ml of blood 3 months after implementation of the full ReDO protocol compared to baseline, that is 5 months after 0 months (baseline)];Circulating Tumour Cell (CTC) count in CTC/ml[blood test as above - Isolation of CTC from blood by filtration and analyses by microscopy 6 months after implementation of the full ReDO protocol compared to baseline, that is 8 months after 0 months (baseline)] Dr Taufiq Binjemain All 20 Years - No limit 50 Patients at the Willow Vale Clinic Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy; 30/11/2023 09/11/2023 20/11/2023 https://anzctr.org.au/ACTRN12623001164684.aspx Any/All Stages Hospital/University/Research Institute N N N Australia Multiple cancer types Multiple cancer types Atorvastatin; Chloroquine; Dipyridamole; Doxycycline; Hydroxychloroquine; Ivermectin; Loratadine; Mebendazole; Melatonin; Metformin; Phenylbutyrate Biomarker Other DB01117; DB00477; DB00822; DB04855; DB07118; DB01221; DB00678; DB00737; DB00814; DB00703; DB00252 N
CTRI/2023/11/059909 Utility of Hydroxychloroquine medicine as a supportive treatment for breast cancer patients Not Yet Recruiting Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Intervention1: Hydroxychloroquine (Brand Name-HCQS): Hydroxychloroquine (HCQ)
DOSAGE FORM: 200 mg tablet, oral route
DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg FREQUENCY: HCQ is taken twice daily (morning and night) with food. DURACTION OF HCQ: 2 weeks
Intervention2: Hydroxychloroquine (Brand Name-HCQS): DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg FREQUENCY: HCQ is taken twice daily (morning and night) with food. DURACTION OF HCQ: 2 weeks. Oral route.
Intervention3: ARM - A-Hydroxychloroquine (HCQ): ARM A- The patients will be randomized to one of the following arms to receive HCQS and neoadjuvant chemotherapy (NACT).
10 patients will be recruited for each arm.
Neoadjuvant chemotherapy € dose dense AC x 4 cycles followed by 12 weekly paclitaxel. NACT followed by HCQS for 2 weeks followed by surgery. Hydroxychloroquine (HCQ)
DOSAGE FORM: 200 mg tablet, oral route
DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg FREQUENCY: HCQ is taken twice daily (morning and night) with food. DURACTION OF HCQ: 2 weeks
Intervention4: ARM B- Hydroxychloroquine (HCQ): ARM B -The patients will be randomized to one of the following arms to receive HCQS and neoadjuvant chemotherapy (NACT).
10 patients will be recruited for each arm.
Neoadjuvant chemotherapy € dose dense AC x 4 cycles followed by 12 weekly paclitaxel.
Surgery € BCS/MRM
HPE examination to look for T and N pathological response rates. NACT followed by 2 weeks of gap and then surgery
Hydroxychloroquine (HCQ)
DOSAGE FORM: 200 mg tablet, oral route
DOSAGE: 200 mg BID by mouth, for a total daily dose of 400 mg FREQUENCY: HCQ is taken twice daily (morning and night) with food. DURACTION OF HCQ: 2 weeks
Intervention5: ARM C- Hydroxychloroquine (HCQ): ARM C - The patients will be r 1.Demographiccharacteristics,clinicalpresentations, histopathologyreports, diagnostic results, and treatment details.
2.Genomic and proteomic analysis will be carried out.
3.Change in Prostate Apoptosis Response-4 (PAR-4) Levels.
4.PAR-4 levels measured via serum or plasma blood sample.
Timepoint: 0 weeks, 2 weeks and at the end of treatment Dr Ananth Pai - - 30 No 2 , 1st floor, Department of Medical Oncology, Shridi Sai baba cancer institute and Research block, Kasturba Medical College and Hospital, Manipal, Udupi Interventional Study Cluster Randomized Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label 13/01/2024 16/11/2023 19/12/2023 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=93218 Localised/Locoregional Hospital/University/Research Institute Y N N India Breast Breast Cancer - TNBC Hydroxychloroquine Response rate; Biomarker Phase 4 DB07118 N
CTIS2023-503938-52-00 Clinical and translational controlled study of Perampanel treatment around Surgery in patients with progressive glioblastoma (PerSurge) Recruiting Progressive Glioblastoma
MedDRA version: 20.0Level: PTClassification code: 10018336Term: GlioblastomaSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Neoplasms [C04];MedDRA version: 20.0Level: PTClassification code: 10018336Term: GlioblastomaSystem Organ Class: 100000004864 Product Name: F llstoff DAC in hard gelatine capsules is used as placebo. F llstoff DAC consists of mannitol 99.5 and
colloidal Silicon Dioxide 0.5 .,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: Fycompa 2 mg film-coated tablets,Product Code: PRD4442834,Pharmaceutical Form: FILM-COATED TABLET,Other descriptive name: ,Strength: Perampanel 2mg Main Objective:The primary aim of the trial is to demonstrate the efficacy of pre-surgical perampanel compared
to placebo treatment with respect to
A) the shift of mRNA expression patterns to a lower connectivity score in tumour tissue,
and
B) the presurgical tumour growth rate as assessed by tumour volume [cm ] per a central blinded
independent review committee (BIRC) based on AI-quantified MRI parameters (T2/FLAIRweighted
images)
in patients with recurrent/progressive glioblastoma willing to adhere to the randomised treatment
and who will undergo surgery.;Secondary Objective:kinetics in contrast-enhancing (T1CE images) tumour volume by central AI-based MRI assessment per BIRC [pre-surgical; postsurgical ],kinetics in tumour volume (T2/FLAIR) by central AI-based MRI assessment per the BIRC [postsurgical],health-related quality of life (HRQoL) and symptoms as assessed by the EORTC QLQ-C30 and QLQ-BN20 patient questionnaires,,severity of cognitive impairment as assessed by the mini-mental state examination (MMSE),overall survival (OS),progression-free survival (PFS) (from randomisation until progression according to RANO criteria),epileptic seizure activity,To check for the occurrence of the adverse effects reported in the summary of the medical product characteristics (SmPC) of the drug and to compare between both treatments.;Primary end point(s):A) Connectivity score determined in RNA Seq from tumour tissue (tumour cryosamples),B) Kinetics in T2/FLAIR signal abnormality volume by central AI-based MRI assessment per BIRC [from baseline to pre-surgical resection] Universitaetsklinikum Heidelberg A R Female 18 - 65+ 66 BMBF Interventional Study Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: 2 30/11/2023 13/09/2023 27/05/2024 https://euclinicaltrials.eu/app/#/view/2023-503938-52-00?lang=en Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute Y N N Germany CNS Glioblastoma Perampanel Response rate; Biomarker Phase 1 DB01074 N
NCT06030622 Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer C3 RECRUITING Pancreatic Cancer Metastatic DRUG: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin); DRUG: C3 (Metformin, Simvastatin, and Digoxin) only Primary Outcome: Safety and tolerability, Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0, 28 days State University of New York - Downstate Medical Center All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER 1727019-4 17/04/2024 12/01/2024 12/01/2024 09/11/2023 19/04/2024 https://clinicaltrials.gov/study/NCT06030622 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Digoxin; Metformin; Simvastatin Safety and/or Dose; Biomarker Phase 1/2 DB08908; DB00703; DB00877 N
NCT02874430 Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer ACTIVE_NOT_RECRUITING Breast Carcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Uterine Corpus Cancer|Uterine Corpus Carcinosarcoma DRUG: Metformin Hydrochloride; DRUG: Doxycycline Change in the percent of stromal cells expressing Caveolin-1 (CAV1) at an intensity of 1+ or greater assessed by immunohistochemistry, Within-patient change in immunohistochemistry scores will be analyzed using the Wilcoxon signed-rank test., Baseline to week 6 Sidney Kimmel Cancer Center at Thomas Jefferson University Female ADULT, OLDER_ADULT 27 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 16D.317 06/08/2016 12/02/2020 06/01/2023 22/08/2016 15/12/2022 https://clinicaltrials.gov/study/NCT02874430 Localised/Locoregional Hospital/University/Research Institute N N N United States Breast; Gynaecological Any Breast Cancer; Endometrial Cancer Doxycycline; Metformin Safety and/or Dose; PFS; OS; Biomarker Phase 2 DB04855; DB00703 N
NCT05487859 Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC) NOT_YET_RECRUITING Kidney Cancer DRUG: Acarbose Tablets To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC, adverse events will be defined and assessed using the National Cancer Institute's Common Terminology Criteria (CTCAE) v5.0, 2 years; To assess the effect of acarbose on the gut microbiome in patients receiving as standard of care therapy., Fecal microbiota populations will be characterized prior, during and after treatment with acarbose., 2 years University of Alabama at Birmingham All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT UAB23143 10/05/2025 10/06/2025 10/06/2025 08/04/2022 17/01/2024 https://clinicaltrials.gov/study/NCT05487859 Advanced/Metastatic Other N N N United States Urological Renal Cell Carcinoma Acarbose Safety and/or Dose; Biomarker Phase 2 DB00316 N
NCT03467360 Inhibition of CArbonic Anhydrase in Combination With Platinum and Etoposide-based Radiochemotherapy in Patients With Localized Small Cell Lung Cancer ICAR RECRUITING Small Cell Lung Cancer DRUG: acetazolamide in combination with platinum and etoposide-based radiochemotherapy To identify the Tolerated Maximum Dose (DMT) and Recommended Dose (DR) of acetazolamide in combination with radiotherapy combined with platinum and etoposide chemotherapy, The frequency of limiting dose toxicities determined by the number of Adverse Events as Assessed by CTCAE v4.03 during the 6 weeks of treatment with acetazolamide / chemoradiation based on platinum and etoposide and in the first 6 months of follow-up after the last administration of the treatment, 32 months Centre Antoine Lacassagne All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2017/14 08/02/2019 27/10/2026 27/04/2027 16/03/2018 02/12/2024 https://clinicaltrials.gov/study/NCT03467360 Localised/Locoregional Hospital/University/Research Institute N N N France Lung Small Cell Lung Cancer Acetazolamide Safety and/or Dose Phase 1 DB00945 N
NCT03011671 Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma RECRUITING Malignant Glioma of Brain DRUG: Acetazolamide; DRUG: Temozolomide Number of participants with adverse events, To determine the safety, tolerability and adverse event profile of adding acetazolamide to temozolomide in patients with newly diagnosed malignant astrocytoma., 28 Days University of Chicago All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRB16-0767 10/03/2018 10/01/2026 10/01/2026 01/05/2017 13/05/2024 https://clinicaltrials.gov/study/NCT03011671 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioma Acetazolamide Safety and/or Dose; Response rate; PFS; OS Phase 1 DB00945 N
NCT05470283 Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma ACTIVE_NOT_RECRUITING Tumor|Metastatic Melanoma|Melanoma DRUG: OBX-115; DRUG: Acetazolamide; DRUG: Cyclophosphamide; DRUG: Furosemide; DRUG: Mesna; DRUG: Fludarabine Phosphate Incidence and nature of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 + acetazolamide administration as assessed by CTCAE version 5.0. Incidence and severity of AEs and SAEs after OBX-115 + acetazolamide administration., through completion of study, an average of 1 year M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 21 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2022-0356; NCI-2022-06873 09/07/2022 04/01/2027 04/01/2027 22/07/2022 04/11/2024 https://clinicaltrials.gov/study/NCT05470283 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Acetazolamide Safety and/or Dose Phase 1 DB00945 N
NCT02366884 Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011) UNKNOWN Neoplasms DRUG: Anti-Bacterial Agents; DRUG: Anti-Fungal Agents; DRUG: Anti-Protozoal Agents Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response, Tumor regression will be measrued objectively and assessments appropriate for the type of cancer treated. Outcome measures may include 1) Changes in signs and symptoms; (2) Visual inspection of tumors using weekly photographs and measurements (as appropriate); (3)Monthly chest X-rays to monitor lung tumors, lung metastases and/or fluid in the chest; (4) Ultrasound to evaluate abdominal tumors (e.g., liver metastases), and breast and armpit lymph nodes; (5) CT, MRI and PET scans; (6) Tumor markers in blood such as Carcinoembryonic Antigen (CEA), CA-15.3, CA-19-9 and other laboratory studies to monitor response., 6 Months Dr. Frank Arguello Cancer Clinic All CHILD, ADULT, OLDER_ADULT 250 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT ACI/2015 26/07/2011 31/12/2022 31/12/2023 19/02/2015 04/06/2022 https://clinicaltrials.gov/study/NCT02366884 Any/All Stages Other N N N Mexico Multiple cancer types Multiple cancer types Albendazole; Chloroquine; Clarithromycin; Clotrimazole; Dapsone; Doxycycline; Itraconazole; Ivermectin; Levamisole; Mebendazole; Metronidazole; Miconazole; Miltefosine; Nitazoxanide; Terbinafine Safety and/or Dose; Response rate Phase 2 DB00630; DB00477; DB00283; DB01394; DB01609; DB04855; DB00602; DB01221; DB01202; DB00737; DB01011; DB00683; DB01017; DB00348; DB08880 N
NCT05049863 Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial) RECRUITING Small-cell Lung Cancer|Small Cell Lung Carcinoma DRUG: Mycophenolate Mofetil; DRUG: Allopurinol; DRUG: Irinotecan Number of study treatment related adverse events as measured by NCI-CTCAE v 5.0 (Phase I only), Through 30 days after completion of treatment (estimated to be 5 months); Overall response rate (ORR) (Phase II and phase I patients who receive the MTD), * ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.* Partial Response (PR): At least a 30 decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters., Through completion of treatment (estimated to be 4 months); Recommended phase II dose (RP2D) (Phase I only), -The recommended phase II dose (RP2D) is defined as the dose level at which fewer than 2 patients of a cohort of 6 patients experience dose-limiting toxicity during the first cycle., Completion of cycle 1 (each cycle is 21 days) of all enrolled Phase I participants (estimated to be 10 months); Number of discontinuations due to treatment related adverse events (Phase I only), Through completion of treatment (estimated to be 4 months); Number of DLTs in Phase I patients, Completion of cycle 1 (each cycle is 21 days) of all enrolled Phase I participants (estimated to be 10 months) Washington University School of Medicine All ADULT, OLDER_ADULT 36 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 202301066 27/02/2023 30/04/2025 31/10/2025 20/09/2021 22/11/2023 https://clinicaltrials.gov/study/NCT05049863 Recurrent/Refractory Hospital/University/Research Institute N N N United States Lung Small Cell Lung Cancer Allopurinol; Mycophenolate Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00166; DB08813 N
NCT04691765 Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients Anakinra UNKNOWN Chronic Lymphocytic Leukemia DRUG: Kineret Safety and dose limiting toxicities of anakinra in CLL patients, The primary endpoints relate to safety and tolerability of anakinra in this patient, including numbers of patients with treatment-related adverse events (AEs) as assessed by CTCAE v4.0, 1 year Dr. David Spaner All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT Anakinra 05/01/2021 12/01/2021 12/01/2022 31/12/2020 19/03/2021 https://clinicaltrials.gov/study/NCT04691765 Localised/Locoregional Hospital/University/Research Institute N N N Sweden Leukemia Chronic Lymphocytic Leukemia Anakinra Safety and/or Dose Phase 1 DB00673 N
NCT04942626 Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients ACO/ARO/AIO-21 ACTIVE_NOT_RECRUITING Rectal Cancer DRUG: Kineret 100 MG in 0.67 ML Prefilled Syringe; DRUG: Capecitabine; RADIATION: Radiotherapy; PROCEDURE: Watch and Wait (cCR) or TME surgery (non-cCR) Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c., Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, 16 weeks; Identification of the maximum tolerated dose for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c, Identification of the maximum tolerated dose for capecitabine in combination with radiotherapy and Anakinra based on 3+3 design, 16 weeks Goethe University All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ACO/ARO/AIO-21 20/08/2021 31/12/2024 31/12/2025 28/06/2021 12/04/2023 https://clinicaltrials.gov/study/NCT04942626 Localised/Locoregional Hospital/University/Research Institute N N N Germany GI Rectal Cancer Anakinra Safety and/or Dose; Response rate; PFS; DFS/RFS/EFS Phase 1 DB00673 N
NCT03093129 Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V) NeoART-V UNKNOWN Colorectal Cancer DRUG: artesunate; OTHER: placebo recurrence free survival 2 years after surgery, The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery, 2 years The 108 Military Central Hospital All ADULT, OLDER_ADULT 200 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT NeoArt-V 01/08/2018 12/01/2021 12/01/2022 28/03/2017 01/09/2018 https://clinicaltrials.gov/study/NCT03093129 Localised/Locoregional Hospital/University/Research Institute Y N N Viet Nam GI Colon Cancer; Rectal Cancer Artesunate Safety and/or Dose; OS; DFS/RFS/EFS Phase 2 DB00126 N
NCT04026230 Impact of Atorvastatin on Prostate Cancer Progression During ADT ESTO2 RECRUITING Metastatic Prostate Cancer|Recurrent Prostate Cancer DRUG: Atorvastatin 80mg; DRUG: Placebo oral capsule Castration resistance, Castration resistance is defined as PSA progression (three consecutive PSA rises measured at least 1 week apart with two \> 50 increases over the nadir and PSA \> 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (\< 1.73 nmol/l; 50 ng/dl) during ADT., From date of randomization until the date of first occurrence of castration resistance, assessed up to 60 months Tampere University Hospital Male ADULT, OLDER_ADULT 400 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT 2016-004774-17 15/08/2019 31/12/2025 31/12/2025 19/07/2019 21/10/2022 https://clinicaltrials.gov/study/NCT04026230 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N Finland Urological Prostate Cancer Atorvastatin PFS Phase 3 DB01117 N
NCT06102863 Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia RECRUITING Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I DRUG: statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day); Pathological cumulative complete response rate;, 3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,, assessed up to 4 months Peking University People's Hospital Female CHILD, ADULT 38 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 20231022 04/01/2023 12/01/2024 02/01/2025 26/10/2023 28/05/2024 https://clinicaltrials.gov/study/NCT06102863 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Atorvastatin; Rosuvastatin Safety and/or Dose; Response rate; Recurrence rate Phase 2 DB01117; DB10276 N
NCT03560882 A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies ACTIVE_NOT_RECRUITING Malignant Disease|Solid Tumor|Acute Myeloid Leukemia|Myelodysplastic Syndromes|Cancer|Relapsed Hematologic Malignancy DRUG: Atorvastatin Change in conformational mutant tumor protein 53 (p53), Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53., baseline and up to 4 weeks Joaquina Baranda All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT-2018-p53Atorva 19/07/2018 14/10/2022 08/01/2025 18/06/2018 21/03/2024 https://clinicaltrials.gov/study/NCT03560882 Any/All Stages Hospital/University/Research Institute N N N United States Multiple cancer types; Leukemia Any solid tumours; Any leukemias Atorvastatin Biomarker Phase 1 DB01117 N
NCT05998135 Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer RECRUITING Ovarian High Grade Serous Adenocarcinoma|Platinum-Resistant Ovarian Carcinoma DRUG: Atovaquone; PROCEDURE: Biopsy; PROCEDURE: Computed Tomography; PROCEDURE: Paracentesis Progression free survival (PFS), Will be estimated using the Kaplan-Meier method, and a 95 confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach., From initiation of atovaquone to progression or death, assessed up to 1 year Emory University Female ADULT, OLDER_ADULT 28 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY00005363; NCI-2023-03479; STUDY00005363; WINSHIP5782-22; P30CA138292 11/09/2023 30/06/2024 30/06/2025 18/08/2023 20/02/2024 https://clinicaltrials.gov/study/NCT05998135 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Ovarian Epithelial Cancer Atovaquone Safety and/or Dose; PFS; OS; Other (specify) Phase 2 DB15591 N
NCT03568994 Atovaquone (Mepron ) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) ATACC AML ACTIVE_NOT_RECRUITING Acute Myeloid Leukemia DRUG: Atovaquone; DRUG: Cytarabine; DRUG: Daunorubicin; DRUG: Etoposide; DRUG: Gemtuzumab Ozogamicin Plasma Concentrations, The investigators will determine plasma levels of atovaquone at the following time points: Day 6, 11, 13, 15, 18, 20, 22, 29 and on the day of the end of induction bone marrow (BM) assessment (generally around Day 36)., 5 weeks; Dose Omission Frequency, To quantify the frequency of atovaquone doses omitted due to standard MRC related toxicity. Administration of doses of atovaquone will be monitored while the patient is hospitalized in the electronic medical record and abstracted to case report forms. Families will also be given a diary to complete., 5 weeks; Time to Achieve Steady State, Time to achieving steady state concentrations of atovaquone when given in combination with standard chemotherapy in children with de novo AML will be determined using stepwise tests of linear trend., 5 weeks Baylor College of Medicine All CHILD, ADULT 26 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT H-42691 07/10/2018 29/09/2020 31/10/2025 26/06/2018 28/03/2024 https://clinicaltrials.gov/study/NCT03568994 Any/All Stages Hospital/University/Research Institute N N N United States Leukemia Acute Myeloid Leukemia, Adult Atovaquone Safety and/or Dose Phase 1 DB15591 N
NCT03456700 Auranofin and Sirolimus in Treating Participants With Ovarian Cancer ACTIVE_NOT_RECRUITING Ovarian Serous Tumor|Recurrent Ovarian Carcinoma DRUG: Auranofin; OTHER: Laboratory Biomarker Analysis; DRUG: Sirolimus Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart), The outcome measure is the number of participants with a confirmed tumor response (partial response \[PR\] or complete response \[CR\] at least 4 weeks apart). PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30 decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm., 1 year 4 months Mayo Clinic Female ADULT, OLDER_ADULT 22 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MC1761; NCI-2018-00321; MC1761; P30CA015083; 17-005302 30/03/2018 31/07/2019 30/06/2025 03/07/2018 07/02/2020 24/06/2024 https://clinicaltrials.gov/study/NCT03456700 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Ovarian Epithelial Cancer Auranofin; Sirolimus Response rate Phase 2 DB00972; DB01261 N
NCT04812808 Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma BAZE UNKNOWN Pancreas Cancer DRUG: Bazedoxifene 20 mg Change in IL-6/GP-130/STAT3 pathway expression ( ), Assessment of IL-6 (GP130/STAT3) activity by immunohistochemistry on metastasis biopsy before and after treatment with bazedoxifene in addition to chemotherapy., 3 months H pital Fribourgeois All ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT Grant-2104 02/01/2022 31/01/2024 31/05/2024 24/03/2021 25/02/2022 https://clinicaltrials.gov/study/NCT04812808 Advanced/Metastatic Hospital/University/Research Institute N N N Switzerland GI Pancreatic Cancer Bazedoxifene Biomarker Other DB08903 N
NCT04997811 Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes REPAIR-MDS RECRUITING Myelodysplastic Syndromes (MDS) DRUG: Sodium Valproate, Bezafibrate, Medroxyprogesterone; DRUG: Danazol Haematological improvement (HI) in each arm and in the trial overall, with 25 or more of the participants having HI in each arm and overall., HI will be assessed in each participant by comparing post randomisation FBC parameters (Haemoglobin, platelet and neutrophil counts) and transfusion requirements, with their individual baseline as determined by the IWG 2018 haematology response criteria in patients with MDS., 12 months Prof. Janet Dunn All ADULT, OLDER_ADULT 120 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT SOC.11/20-21; 2020-005446-42 21/12/2021 31/01/2025 30/06/2025 08/10/2021 10/03/2023 https://clinicaltrials.gov/study/NCT04997811 Any/All Stages Hospital/University/Research Institute N Y N United Kingdom Other Haem-onc Myelodysplastic Syndromes Bezafibrate; Danazol; Valproic Acid OS; QoL; Other (specify) Phase 2 DB00810; DB06292; DB00177 N
NCT04158635 Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer RECRUITING Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8|Unresectable Pancreatic Carcinoma DRUG: Bosentan; DRUG: Gemcitabine; DRUG: Nab-paclitaxel; OTHER: Quality-of-Life Assessment; OTHER: Questionnaire Administration Incidence of adverse events, Will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0., Up to 30 days after last dose of protocol therapy; Dose limiting toxicities (DLTs), Toxicities will be graded according to NCI CTCAE v 4.0. DLT's apply only to bosentan-only single stage AND cycle 1 and should be attributable to the treatment., Up to 21 days (Cycle 1); Compliance, Number of bosentan tablets and bottles returned will be reconciled with the patient diary., During the first week City of Hope Medical Center All ADULT, OLDER_ADULT 21 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 21314; NCI-2021-06609; 19312 09/01/2021 27/01/2026 27/01/2026 11/12/2019 20/05/2024 https://clinicaltrials.gov/study/NCT04158635 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Bosentan Safety and/or Dose Phase 1 DB09128 N
NCT03107416 Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells ACTIVE_NOT_RECRUITING Unresectable Hepatocellular Carcinoma PROCEDURE: Hepatic artery embolization (HAE); DRUG: Bumetanide Maximum tolerated dose (MTD) (phase I), Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level., 1 year; estimate the local tumor progression (LTP) rates (phase II), After the last first stage patient has three months followup, 6-month LTP will be estimated using Kaplan-Meier methods. If the one-sided 90 lower confidence bound is less than 40 the study will stop. Otherwise 12 more patients will be enrolled for a total of 30. At the end of the study 12-month LTP will be estimated using competing risk (cumulative incidence) methods., 1 year Memorial Sloan Kettering Cancer Center All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 17-141 04/05/2017 04/05/2025 04/05/2025 04/11/2017 30/04/2024 https://clinicaltrials.gov/study/NCT03107416 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Liver Cancer Bumetanide Safety and/or Dose; Other (specify) Phase 1/2 DB00297 N
NCT04073680 A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors UNKNOWN Breast Cancer|Endometrial Cancer|Lung Cancer|Colo-rectal Cancer|Head and Neck Cancer DRUG: Serabelisib; DRUG: Canagliflozin 300mg Rate of Adverse Events, Safety of serabelisib in combination with canagliflozin as evaluated by incidence of drug-related adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities., 30 days after last dose; Rate of Laboratory Abnormalities, Safety of serabelisib in combination with canagliflozin as evaluated by incidence of clinical laboratory abnormalities, 30 days after last dose; Dose confirmation, To confirm the appropriate dose of serabelisib to be coadministered with canagliflozin, 6 months; Tumor Assessments by RESIST, To assess efficacy of serabelisib in combination with canagliflozin in patients with solid tumors with PIK3CA or KRAS mutations, 2 years Petra Pharma All ADULT, OLDER_ADULT 60 INDUSTRY Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT PT06-01 09/01/2020 15/07/2021 30/12/2021 29/08/2019 21/05/2020 https://clinicaltrials.gov/study/NCT04073680 Advanced/Metastatic Company N N N United States Multiple cancer types Any solid tumours Canagliflozin Safety and/or Dose; Response rate Phase 1/2 DB13919 N
NCT05903703 Canagliflozin With Gemcitabine in Pancreatic Carcinoma NOT_YET_RECRUITING Pancreatic Cancer DRUG: Canagliflozin and Gemcitabine; DRUG: Gemcitabine Evaluation the clinical complete response (CR) at 6 weeks intervals, The tumor lesion in our patient completely resolved and lasted for 4 weeks, and no new lesion appeared, 18 weeks; Evaluation the clinical partial response (PR) at 6 weeks intervals, the overall reduction in the longest diameter of the tumor focus is \> 50 and it can be maintained for at least 4 weeks, with no new focus emerging, 18 weeks; Evaluation the clinical stable disease (SD) at 6 weeks intervals, the overall reduction or increase of the longest diameter of the tumor lesion is \< 50 or \< 25 , and the duration is \> 4 weeks; no new lesion appears, 18 weeks; Evaluation the clinical disease progression (PD) at 6 weeks intervals, the combined increase in the longest diameter of the tumor lesion is 25 , or a new lesion appears, 18 weeks Zhang Xiaofeng,MD All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 20230519 10/01/2023 30/09/2026 31/03/2027 15/06/2023 15/06/2023 https://clinicaltrials.gov/study/NCT05903703 Advanced/Metastatic; Other (specify) Hospital/University/Research Institute Y N N China GI Pancreatic Cancer Canagliflozin Response rate Other DB13919 N
NCT02944201 Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate UNKNOWN Prostate Cancer DRUG: Carvedilol Change in Biomarkers in Prostate Biopsy Compared to Prostatectomy Tissues, BIomarker, 28 days after beginning carvedilol Montefiore Medical Center Male ADULT, OLDER_ADULT 22 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2016-6632 04/01/2017 31/12/2020 31/12/2021 25/10/2016 21/02/2021 https://clinicaltrials.gov/study/NCT02944201 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Prostate Cancer Carvedilol Biomarker Phase 2 DB00482 N
NCT04469530 Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors AflacST1903 RECRUITING Solid Tumor DRUG: Sirolimus; DRUG: Cyclophosphamide; DRUG: Etoposide; DRUG: Celecoxib Two-year progression-free survival in patients with high-risk solid tumors, Two-year progression-free survival in patients with high-risk solid tumors who complete a 12- month course of maintenance chemotherapy with daily sirolimus and twice daily celecoxib on a backbone of low-dose oral metronomic chemotherapy following completion of standard therapy as compared to a historical cohort of matched patients treated with observation only following completion of standard therapy., up to 2 years Emory University All CHILD, ADULT 50 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00000113 16/09/2020 09/01/2025 09/01/2025 14/07/2020 25/10/2023 https://clinicaltrials.gov/study/NCT04469530 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N Y United States Multiple cancer types Multiple cancer types Celecoxib; Sirolimus DFS/RFS/EFS Phase 2 DB00567; DB01261 N
NCT05756166 Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer RECRUITING Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Triple-Negative Breast Carcinoma|Unresectable Triple-Negative Breast Carcinoma PROCEDURE: Biopsy; PROCEDURE: Biospecimen Collection; DRUG: Celecoxib; PROCEDURE: Computed Tomography; BIOLOGICAL: Interferon Alpha-2; PROCEDURE: Magnetic Resonance Imaging; BIOLOGICAL: Pembrolizumab; DRUG: Rintatolimod Incidence of adverse events, The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies., Up to 2 years Roswell Park Cancer Institute All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT I-3010822; NCI-2023-01262; I-3010822; P01CA234212 16/02/2024 30/06/2025 30/06/2025 03/06/2023 30/05/2024 https://clinicaltrials.gov/study/NCT05756166 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Celecoxib Safety and/or Dose Phase 1/2 DB00567 N
NCT05647330 Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer NOT_YET_RECRUITING Hydroxychloroquine|Gemcitabine|Lung Neoplasms DRUG: Hydroxychloroquine Combined With Gemcitabine Objective response rate(ORR), The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete and partial remission., 1years Henan Cancer Hospital All ADULT, OLDER_ADULT 55 OTHER_GOV Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2022213 15/12/2022 10/01/2024 10/01/2025 12/12/2022 12/12/2022 https://clinicaltrials.gov/study/NCT05647330 Advanced/Metastatic Hospital/University/Research Institute N N N China Lung Non-Small Cell Lung Cancer Hydroxychloroquine Response rate; PFS; OS Phase 2 DB07118 N
NCT04224441 Repurposing Chlorpromazine in the Treatment of Glioblastoma RACTAC UNKNOWN Glioblastoma Multiforme|MGMT-Unmethylated Glioblastoma DRUG: Chlorpromazine Pill Evaluation of toxicity, Toxicity evaluation of the combined treatment. Subjects will be evaluated for symptoms and adverse effects according to the NCI-CTCAE version 5.0 grading tool, 6 months; Progression-free survival (PFS), Effect of of adding CPZ to the standard GBM therapy, when compared with the standard therapy alone, 6 months Marco G Paggi, MD, PhD All ADULT, OLDER_ADULT 41 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2019-001988-75 15/12/2019 15/06/2022 15/12/2022 13/01/2020 13/01/2020 https://clinicaltrials.gov/study/NCT04224441 Localised/Locoregional Hospital/University/Research Institute N N N Italy CNS Glioblastoma Chlorpromazine Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00169 N
NCT05190315 Chlorpromazine and Standard of Care in Glioblastoma ACTIVE_NOT_RECRUITING Glioblastoma Multiforme DRUG: Chlorpromazine; DRUG: Temozolomide; RADIATION: Radiation Therapy Safety and acute toxicity of chlorpromazine (CPZ) when administered throughout the standard treatment for glioblastoma multiforme (GBM) will be graded per NCI's Common Terminology Criteria for Adverse Events v 5.0 (CTCAE v5.0), The incidence of treatment-emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, and severity (based on NCI CTCAE v5.0 grades), First treatment through 30 days post last dose of study drug; Recommended phase II dose of chlorpromazine in combination with the standard treatment protocol for glioblastoma, The study will utilize a 3+3 design, and up to 6 patients will be treated at each dose level. The recommended Phase II dose will be defined as the highest dose level for which at most 1 of 6 patients experience a dose limiting toxicity (DLT)., 4 weeks Mohammed Milhem All ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 202109340 28/01/2022 07/01/2024 07/01/2024 13/01/2022 29/08/2023 https://clinicaltrials.gov/study/NCT05190315 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma; Glioma; DIPG/DMG Chlorpromazine Safety and/or Dose Phase 1 DB00169 N
NCT04063189 Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma UNKNOWN Multiple Myeloma in Relapse DRUG: Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen Objective response rate (ORR), According to the criteria of IMWG 2016, Every 2 months until disease progression or study completion an average of 2 year The First Hospital of Jilin University All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT BiRd 2017-288-1 21/03/2017 02/01/2020 02/01/2020 21/08/2019 21/08/2019 https://clinicaltrials.gov/study/NCT04063189 Recurrent/Refractory Hospital/University/Research Institute N N N China Other Haem-onc Multiple Myeloma Clarithromycin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00283 N
NCT02575144 GEM-CLARIDEX: Ld vs BiRd GEM-CLARIDEX ACTIVE_NOT_RECRUITING Multiple Myeloma DRUG: Clarithromycin; DRUG: Lenalidomide; DRUG: Dexamethasone Progression free survival, Throught the study. Approximately 4 years PETHEMA Foundation All ADULT, OLDER_ADULT 286 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT GEM-CLARIDEX 09/01/2015 10/01/2024 10/01/2024 14/10/2015 02/01/2022 https://clinicaltrials.gov/study/NCT02575144 Primary/Main Curative Any/All Stages Collaborative Group Y N N Spain Other Haem-onc Multiple Myeloma Clarithromycin PFS Phase 3 DB00283 N
NCT03245489 Pembrolizumab in Combination With Anti-platelet Therapy for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck RECRUITING Head and Neck Cancer DRUG: Pembrolizumab; DRUG: Clopidogrel; DRUG: acetylsalicylic acid Effect of Pembro + antiplatelet on major cellular parameters, Immunologic response profile will be measured by changes in major cellular parameters in peripheral blood mononuclear cells pheotyped by flow cytometry for MDSCs, T and B cell activation markers and polyclonal IFNy-production by CD4 and CD8 response after P/I stimulation) in pembrolizumab alone and pembrolizumab + antiplatelet therapy. Markers will be measured at baseline, end of the first regimen and end of the second regimen. Changes in cellular parameters from the previous timepoint will be evaluated using a repeated measures ANOVA model. Cellular parameters will be evaluated in aggregate to report the immunologic response., 12 weeks Medical University of South Carolina All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT 102727 03/06/2018 30/06/2024 30/09/2024 08/10/2017 06/05/2024 https://clinicaltrials.gov/study/NCT03245489 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Head and Neck Any head and neck squamous cell carcinoma Acetylsalicylic Acid; Clopidogrel Biomarker Phase 1 DB01048; DB00257 N
NCT04264260 Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment RECRUITING Hepatocellular Carcinoma Stage IIIB|Cholangiocarcinoma, Intrahepatic|Cholangiocarcinoma; With Hepatocellular Carcinoma|Hepatocellular Carcinoma Stage IV DRUG: Colchicine Tablets survival, The overall survival of the participants, through study completion, an average of 31 months Kaohsiung Medical University Chung-Ho Memorial Hospital All ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT KMUHIRB-F(II)-20190152 24/12/2019 31/07/2025 31/07/2025 02/11/2020 10/06/2023 https://clinicaltrials.gov/study/NCT04264260 Advanced/Metastatic Hospital/University/Research Institute N N N Taiwan GI Liver Cancer; Cholangiocaricnoma Colchicine OS Phase 2 DB01003 N
NCT05802992 The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients RECRUITING Multiple Myeloma DRUG: Colchicine; DRUG: Lenalidomide Serum M protein, Changes of the level of Serum M protein before and after treatment, [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]; Proportion of bone marrow plasma cells, Changes of the proportion of bone marrow plasma cells before and after treatment, [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]; Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP , Changes of the level of SPEP and UPEP before and after treatment, [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]; Serum free light chain (FLC), Changes of the level of Serum FLC before and after treatment, [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months] Affiliated Hospital of Nantong University All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2022-K043-01 30/03/2022 31/12/2024 31/12/2024 04/07/2023 04/07/2023 https://clinicaltrials.gov/study/NCT05802992 Primary/Main Curative Localised/Locoregional Hospital/University/Research Institute Y N N China Other Haem-onc Multiple Myeloma Colchicine Biomarker Phase 3 DB01003 N
NCT05279690 Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors RECRUITING Urothelial Cancer|Metastatic Solid Tumor DRUG: Colchicine Percent Change in Peripheral blood CRP level, The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment., Baseline and Within 28 days Icahn School of Medicine at Mount Sinai All ADULT, OLDER_ADULT 45 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY-21-01175 14/02/2022 12/01/2024 12/01/2024 15/03/2022 15/02/2024 https://clinicaltrials.gov/study/NCT05279690 Advanced/Metastatic Hospital/University/Research Institute N N N United States Urological; Multiple cancer types Bladder Cancer; Any solid tumours Colchicine Biomarker Phase 1 DB01003 N
NCT05025735 Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer UNKNOWN Metastatic Breast Cancer|HER2-negative Breast Cancer DRUG: Dapagliflozin 10Mg Tab Incidence of all grade hyperglycemia as assessed by CTCAE v5.0, Through study completion, an average of 1 year. Saint Luke's Health System All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CBYL719A0US03T 25/08/2021 12/01/2022 07/01/2023 27/08/2021 19/10/2021 https://clinicaltrials.gov/study/NCT05025735 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Breast Breast Cancer - HER2-; Breast Cancer - ER/HR+ Dapagliflozin Response rate; PFS; Biomarker Phase 2 DB00250 N
NCT04887935 Neoadjuvant SGLT2 Inhibition in High-Risk Localized Prostate Cancer RECRUITING Prostate Cancer|Cancer of Prostate DRUG: Dapagliflozin Frequency and severity of toxicities related to dapagliflozin as measured by CTCAE v 5.0, From cycle 1 day 1 (the cycle is 28 days in length) through 30 days after prostatectomy (approximately day 64); Proportion of patients who are able to successfully complete at least 80 of the planned dapagliflozin doses and undergo radical prostatectomy, The study will be feasible if at least 19 of the 24 enrolled subjects are able to complete at least 80 of the planned dapagliflozin doses and undergo radical prostatectomy as scheduled., At approximately 6 weeks Washington University School of Medicine Male ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 202107070 06/04/2024 31/08/2026 31/08/2026 14/05/2021 06/07/2024 https://clinicaltrials.gov/study/NCT04887935 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Prostate Cancer Dapagliflozin Safety and/or Dose; Other (specify) Phase 1 DB00250 N
NCT04113005 Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer UNKNOWN Castrate Resistance Prostate Cancer DRUG: Desmopressin Number of subjects presenting with AEs within a 21-day period of time post Desmopressin/Docetaxel treatment; nature and severity of AEs (as per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, Appendix B)., Number of subjects presenting with AEs within a 21-day period of time post Desmopressin/Docetaxel treatment; nature and severity of AEs (as per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, Appendix B).The proportion of subjects presenting with hyponatremia at 48-hour time point; severity of hyponatremia as per CTCAE Version 4.03 (Appendix B)., 12 months Sunnybrook Health Sciences Centre Male CHILD, ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT Desmopressin Trial 10/01/2019 30/04/2020 10/01/2020 10/02/2019 10/02/2019 https://clinicaltrials.gov/study/NCT04113005 Recurrent/Refractory Hospital/University/Research Institute N N N Canada Urological Prostate Cancer Desmopressin Safety and/or Dose Phase 1 DB01119 N
NCT01653925 Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression ACTIVE_NOT_RECRUITING Prostatic Neoplasms|Low Grade Prostate Cancer OTHER: Dietary intervention first; DRUG: Drug (Dutasteride) intervention first Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment, In this aim the investigators will measure the effects of the interventions on the fatty acid profile of phospholipids from RBC and from snap frozen prostate tissue. Fatty acid profile from prostatic tissue has never been studied. The investigators aim that change in fatty acid intake will affect fatty acid profile of prostatic tissue. Fatty acid profile from red blood cells will serve as a marker of dietary fatty acid intake. Previous studies have shown that fatty acids profile from RBC differs from the one from muscle tissue and that the dietary effect on RBC fatty acids profile is almost maximal within 6 months., 0-6-12 months CHU de Quebec-Universite Laval Male ADULT, OLDER_ADULT 120 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION INAF-2010-H09-10-114 11/01/2010 31/12/2016 12/01/2024 31/07/2012 02/08/2024 https://clinicaltrials.gov/study/NCT01653925 Localised/Locoregional Hospital/University/Research Institute Y N N Canada Urological Prostate Cancer Dutasteride Biomarker Other DB11742 N
NCT05513365 Phase II Dutasteride in Combination With CAB vs CAB in SDC DUCT RECRUITING Salivary Duct Carcinoma DRUG: Goserelin 10.8 mg; DRUG: Bicalutamide 50 mg; DRUG: Dutasteride 0.5 mg Overall Response Rate (ORR), Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years; Duration of Response (DoR), Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years Radboud University Medical Center All ADULT, OLDER_ADULT 26 OTHER Interventional Study Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT MOHN22; 1140022110057 27/09/2022 09/01/2025 09/01/2027 24/08/2022 24/04/2024 https://clinicaltrials.gov/study/NCT05513365 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Netherlands Head and Neck Salivary Gland Cancer Dutasteride Response rate; PFS; OS; QoL; Biomarker Phase 2 DB11742 N
NCT05076682 Reverse Triple Negative Immune Resistant Breast Cancer Renaissance RECRUITING Triple-negative Breast Cancer DRUG: Choline; DRUG: anti-PD-1 antibody and chemotherapy; DRUG: Sodium Cromoglicate; DRUG: Efavirenz Objective Response Rate (ORR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months; Immune changes in peripheral blood, Baseline until disease progression or loss of clinical benefit, assessed up to 6 months Fudan University Female ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2107239-9 30/06/2022 12/01/2022 03/01/2023 13/10/2021 10/03/2022 https://clinicaltrials.gov/study/NCT05076682 Advanced/Metastatic Hospital/University/Research Institute N Y N China Breast Breast Cancer - TNBC Cromoglicic Acid Response rate; PFS; OS; Other (specify) Phase 2 DB00091 N
NCT03838029 Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery BC-PC RECRUITING Pancreatic Neoplasms DRUG: Propranolol and etodolac; OTHER: Placebo Rate of cancer recurrence, Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery, From the date of surgery until malignant disease is identified, assessed up to 60 months post-surgery; Biomarkers in extracted tumor tissue samples, Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples., An average of one year following surgery; Biomarkers in blood samples, Cytokine levels in blood samples (interleukin-6, interleukin-10, C-reactive protein, interferon-gamma, and vascular endothelial growth factor and additional exploratory analysis of other cytokines), An average of one year following surgery Assaf-Harofeh Medical Center All ADULT, OLDER_ADULT 210 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION 0308-17-ASF; MOH_2018-03-12_002226 20/11/2019 01/01/2026 01/01/2026 02/12/2019 20/11/2019 https://clinicaltrials.gov/study/NCT03838029 Localised/Locoregional Hospital/University/Research Institute Y N N Israel GI Pancreatic Cancer Etodolac; Propranolol Recurrence rate Phase 2 DB01628; DB00165 N
NCT03919461 Colorectal Metastasis Prevention International Trial 2 COMPIT-2 RECRUITING Colorectal Neoplasms DRUG: Propranolol and etodolac; OTHER: Placebo 5-year disease-free-survival, Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery. Primary outcome 1 will be rate of recurrence/disease at 60 months., From the date of surgery until malignant disease is identified, assessed up to 60 months post-surgery]; Biomarkers in extracted tumor tissue samples assessing pro- and anti-metastatic processes, Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples, An average of one year following surgery; Biomarkers in blood samples assessing pro- and anti-metastatic processes, Cytokine levels in blood samples (interleukin-6, interleukin-10, C-reactive protein, interferon-gamma, and vascular endothelial growth factor and additional exploratory analysis of other cytokines), An average of one year following surgery Assaf-Harofeh Medical Center All ADULT, OLDER_ADULT 200 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION 0196-17-ASF 28/02/2019 28/02/2027 28/02/2027 18/04/2019 18/04/2019 https://clinicaltrials.gov/study/NCT03919461 Localised/Locoregional Hospital/University/Research Institute Y N N Israel GI Colon Cancer; Rectal Cancer Etodolac; Propranolol DFS/RFS/EFS Phase 2 DB01628; DB00165 N
NCT03647072 PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy RECRUITING Lymphoma DRUG: CHOP; DRUG: CHOP Plus Lanzoprazole; DRUG: CHOP Plus Famotidine Number of patients eith radiological and clinical improvement, Number of patients eith radiological and clinical improvement after cycles of chemotherapy, 6 months Sherief Abd-Elsalam All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT eman elberry 08/01/2018 10/01/2027 12/01/2027 27/08/2018 27/08/2018 https://clinicaltrials.gov/study/NCT03647072 Primary/Main Curative Any/All Stages Hospital/University/Research Institute Y Y N Egypt Lymphoma Lymphoma - Other Famotidine; Lansoprazole Response rate Phase 3 DB08162; DB17289 N
NCT06191133 Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma NOT_YET_RECRUITING Cervical Intraepithelial Neoplasia|Invasive Cervical Cancer DRUG: Fenofibrate; PROCEDURE: Cervical Conization; PROCEDURE: Hysterectomy; RADIATION: Chemoradiation Change in p53 levels, Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery, Up to six weeks after study enrollment; Change in tumor metabolic status, Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing, Up to six weeks after study enrollment Lindsay Ferguson, MD Female ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT CASE3822 08/01/2024 31/01/2025 31/05/2025 01/05/2024 04/12/2024 https://clinicaltrials.gov/study/NCT06191133 Localised/Locoregional Hospital/University/Research Institute N N N United States Gynaecological Cervical Cancer Fenofibrate Safety and/or Dose; Biomarker Phase 1 DB00800 N
NCT01342367 Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer ACTIVE_NOT_RECRUITING Prostate Cancer DRUG: Bicalutamide; DRUG: Dutasteride; DRUG: Finasteride; RADIATION: Radiation Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire, Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here.Scale scores could range from 0-100, with higher scores indicating better quality of life., Baseline, 6 months, and 24 months University of Chicago Male ADULT, OLDER_ADULT 74 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 10-625-A 17/12/2010 05/01/2020 02/01/2026 27/04/2011 28/10/2021 24/05/2024 https://clinicaltrials.gov/study/NCT01342367 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Prostate Cancer Dutasteride; Finasteride QoL Other DB11742; DB08868 N
NCT04049747 Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer IP4-CHRONOS RECRUITING Prostate Cancer|Non-metastatic Prostate Cancer|Prostate Adenocarcinoma PROCEDURE: Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]; PROCEDURE: Focal therapy; PROCEDURE: Focal therapy after Finasteride 5Mg tablets for 12 weeks; PROCEDURE: Focal therapy after Bicalutamide 50Mg tablets for 12 weeks Pilot: Acceptance of randomisation to allocated arm within CHRONOS A CHRONOS B, To assess the acceptance of randomisation to the allocated arm within CHRONOS A \ CHRONOS B using rates of compliance, and rates of withdrawal, 12 months; Pilot: Estimate recruitment rate to allocated arm within CHRONOS A CHRONOS B, To estimate the recruitment rate to allocated arm within CHRONOS A \ CHRONOS B. The main study will be initiated if the minimum target recruitment rate of the Pilot is within the lower end of the confidence interval and funding has been confirmed., 12 months; CHRONOS-A Primary Outcome Measures - progression-free survival (PFS) rates of focal therapy alone compared to radical therapy., To evaluate progression-free survival (PFS) rates of focal therapy alone compared to radical therapy (radiotherapy or surgery) in the treatment of non-metastatic clinically significant prostate cancer. PFS is defined as time from randomisation to salvage whole-gland or systemic therapy, prostate cancer metastases or prostate cancer-specific mortality., 60 months; CHRONOS-B Primary Outcome Measures - Failure-Free-Survival (FFS) rates of focal therapy alone compared to focal therapy combined with other therapies., To evaluate Failure-Free-Survival (FFS) rates of focal therapy alone compared to focal therapy combined with other therapies as a neoadjuvant strategy. FFS is defined as time from randomisation to further focal therapy session or salvage whole-gland or systemic therapy or prostate cancer metastases or prostate cancer-specific mortality., 60 months Imperial College London Male ADULT, OLDER_ADULT 2450 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 19CX5006 12/11/2019 10/01/2021 05/01/2027 08/08/2019 19/04/2021 https://clinicaltrials.gov/study/NCT04049747 Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom Urological Prostate Cancer Finasteride PFS; OS Phase 2/3 DB08868 N
NCT05450055 Intraperitoneal Lidocaine in Ovarian Cancer Surgery NOT_YET_RECRUITING Ovarian Cancer|Post Operative Pain PROCEDURE: intraperitoneal lidocaine analgesic or normal saline as control Postoperative analgesic use, Postoperative intravenous analgesia pump pressing time (recording the time by the electronic analgesia pump) and times (including effective and ineffective pressing times, recording by numbers), intravenous analgesia pump drug usage\[sufentanil ( g)\]., Postoperative 72 hours Peking University Third Hospital Female ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT M2021589 18/07/2022 30/07/2024 30/07/2029 07/08/2022 13/07/2022 https://clinicaltrials.gov/study/NCT05450055 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Ovarian - Other Lidocaine Other (specify) Other DB08882 N
NCT03246074 Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer ACTIVE_NOT_RECRUITING Ovarian Cancer DRUG: Fostamatinib and Paclitaxel Incidence of Treatment-Emergent Adverse Events, To determine the safety, tolerability, and maximum tolerated dose (MTD) of fostamatinib when administered in combination with weekly paclitaxel, 3.5 years Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Female ADULT, OLDER_ADULT 27 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT J1708; IRB00110406 04/03/2018 08/09/2022 10/01/2024 08/11/2017 21/08/2023 https://clinicaltrials.gov/study/NCT03246074 Localised/Locoregional Hospital/University/Research Institute N N N United States Gynaecological Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer Fostamatinib Safety and/or Dose; Response rate; PFS; Biomarker Phase 1 DB01004 N
NCT05030675 Fostamatinib for the Treatment of Lower-risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Who Have Failed Therapy With Hypomethylating Agents ACTIVE_NOT_RECRUITING Refractory Chronic Myelomonocytic Leukemia|Refractory Myelodysplastic Syndrome DRUG: Fostamatinib The PI doesnt wish to add any Outcome Measures this will be add at the time of results, through study completion, an average of 1 year M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 11 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2020-1117; NCI-2021-08494; 2020-1117 13/08/2021 30/04/2025 30/04/2025 09/01/2021 06/12/2024 https://clinicaltrials.gov/study/NCT05030675 Localised/Locoregional Hospital/University/Research Institute N N N United States Other Haem-onc; Leukemia Myelodysplastic Syndromes; Chronic Myelogenous Leukemia Fostamatinib Other (specify) Phase 1 DB01004 N
NCT06102525 A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma NOT_YET_RECRUITING Glioblastoma DRUG: RZ-001; COMBINATION_PRODUCT: VGCV Number of dose limiting toxicities (DLTs), Day 1 to Day 28; Maximum tolerated dose (MTD) or maximum administered dose (MAD) dose(MAD) and select the recommended Phase 2 dose (RP2D) of RZ-001 in combination with VGCV, Day 1 to Day 28; Number of participants with treatment-related adverse events as assessed by NCI-CTCAE, Adverse events (AEs) as characterized by type, number, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\]), timing, seriousness, and relationship to RZ-001, Day 1 to Day 28; Number of participants with significant laboratory abnormalities as assessed by NCI-CTCAE, Clinically significant laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI-CTCAE), timing, and relationship to RZ-001, Day 1 to Day 28; Overall survival (OS), Day 1 to Day 15 Rznomics, Inc. All ADULT, OLDER_ADULT 43 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT RZ-001-201 10/01/2023 03/01/2029 05/01/2029 26/10/2023 26/10/2023 https://clinicaltrials.gov/study/NCT06102525 Localised/Locoregional Company N N N Korea, Republic of CNS Glioblastoma Valganciclovir Safety and/or Dose; PFS; OS Phase 1/2 DB00313 N
NCT04841148 Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer PALAVY RECRUITING Breast Cancer DRUG: HCQ; DRUG: Avelumab; DRUG: Palbociclib Determine the efficacy of HCQ or Avelumab, alone or in combination with Palbociclib, in eradicating DTCs, Endpoint: Proportion of subjects in each treatment arm with clearance of DTCs at the end of 6 cycles of therapy., Efficacy is assessed at the end of Cycle 6 (each cycle is 28 days). Abramson Cancer Center at Penn Medicine All ADULT, OLDER_ADULT 96 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT UPCC 01121; IRB# 848471; TBCRC 046 06/01/2021 11/01/2024 05/01/2028 04/12/2021 03/12/2024 https://clinicaltrials.gov/study/NCT04841148 Localised/Locoregional Hospital/University/Research Institute N Y N United States Breast Breast Cancer - ER/HR+ Hydroxychloroquine Safety and/or Dose; Recurrence rate; Biomarker Phase 2 DB07118 N
NCT01494155 Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer UNKNOWN Pancreatic Cancer DRUG: Capecitabine; DRUG: Hydroxychloroquine; RADIATION: Proton or Photon Radiation Therapy Progression-free survival, To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, chemoradiation therapy and adjuvant gemcitabine chemotherapy, 2 years Massachusetts General Hospital All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 11-073 12/01/2011 01/01/2022 01/01/2023 16/12/2011 02/02/2021 https://clinicaltrials.gov/study/NCT01494155 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine PFS Phase 2 DB07118 N
NCT04735068 Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer ACTIVE_NOT_RECRUITING Non-Small Cell Lung Cancer|KRAS Mutation-Related Tumors DRUG: Binimetinib Pill; DRUG: Hydroxychloroquine Pill Objective Response Rate, 2 years; Number of Patients with Adverse Events as assessed by CTCAE v5.0, 2 years Abramson Cancer Center at Penn Medicine All ADULT, OLDER_ADULT 11 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT UPCC 21520; 844511 04/09/2021 21/08/2022 12/01/2023 02/02/2021 29/06/2023 https://clinicaltrials.gov/study/NCT04735068 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS; Biomarker Phase 2 DB07118 N
NCT04787991 Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma REVOLUTION ACTIVE_NOT_RECRUITING Metastatic Pancreatic Adenocarcinoma DRUG: Nivolumab (Cohort A); DRUG: Ipilimumab (Cohort A, B and C); DRUG: Hydroxychloroquine (HCQ) (Cohort B); DRUG: Nab-paclitaxel (nP) (Cohort A, B and C); DRUG: Gemcitabine (gem) (Cohort A, B and C); DRUG: NG350A (Cohort C) Incidence and severity of adverse events, Up to 2.5 years Cancer Insight, LLC All ADULT, OLDER_ADULT 45 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT PICI0044 08/09/2021 31/10/2024 01/11/2025 03/09/2021 17/01/2024 https://clinicaltrials.gov/study/NCT04787991 Advanced/Metastatic Hospital/University/Research Institute N Y N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS; Other (specify) Phase 1 DB07118 N
NCT03782415 Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma ACTIVE_NOT_RECRUITING Glioblastoma|Recurrent Glioblastoma|GBM|Newly Diagnosed Glioblastoma DRUG: MN-166; DRUG: Temozolomide Evaluate safety and tolerability of ibudilast and temozolomide combination treatment, Determine the proportion of patients with* Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and* Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs)., 1-6 months; Evaluate efficacy of ibudilast and TMZ combination treatment, Proportion of patients who are progression free at 6 months (PFS6) using the RANO criteria., 1-6 months MediciNova All ADULT, OLDER_ADULT 50 INDUSTRY Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MN-166-GBM-1201 29/12/2018 31/12/2023 30/06/2024 20/12/2018 15/03/2024 https://clinicaltrials.gov/study/NCT03782415 Localised/Locoregional; Recurrent/Refractory Company N N N United States CNS Glioblastoma Ibudilast Safety and/or Dose; PFS Phase 1/2 DB01050 N
NCT04863950 Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma RECRUITING Glioblastoma DRUG: Lomustine; DRUG: Imipramine Hydrochloride Progression Free Survival, 6 months The University of Texas Health Science Center at San Antonio All CHILD, ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CTMS# 20-0148 25/05/2022 09/01/2024 09/01/2025 28/04/2021 08/03/2023 https://clinicaltrials.gov/study/NCT04863950 Recurrent/Refractory Hospital/University/Research Institute N N N United States CNS Glioblastoma Imipramine PFS Phase 2 DB00224 N
NCT04018872 Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer RECRUITING Esophagus Adenocarcinoma|Esophagus Squamous Cell Carcinoma|Gastroesophageal Junction Adenocarcinoma DRUG: Itraconazole Percentage of pathological complete response with itraconazole, Generally for esophageal cancer the pathological complete response rate at time of esophagectomy is 25 , and we have designed our study with the projected number of patients assuming we observe an improvement of 15 or more in this rate following treatment with itraconazole. This is the study's primary endpoint. By inhibiting the Hh signaling pathway with the use of itraconazole, we anticipate improved pathological complete response rates., 3-4 months Dallas VA Medical Center All ADULT, OLDER_ADULT 78 FED Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 19-017 24/06/2019 24/06/2026 29/09/2026 15/07/2019 11/04/2021 https://clinicaltrials.gov/study/NCT04018872 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Esophageal Cancer Itraconazole Response rate Phase 2 DB00602 N
NCT05591560 Itraconazole in Advanced Ovarian Cancer NOT_YET_RECRUITING Ovarian Carcinoma DRUG: Itraconazole capsule; DRUG: Placebo The change between 2 groups in overall response rate and disease control rate, The change between 2 groups in overall response rate and disease control rate using the Response Evaluation Criteria in Solid Tumors (RECIST), version. 1.1., 1 week after the end of chemotherapy cycle 3 and 6 (each cycle is 21 days) and every 2 to 4 months after the end of 6 chemotherapy cycles (each cycle is 21 days) for 1 year Tanta University Female ADULT, OLDER_ADULT 66 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT 35929/10/22 10/01/2022 10/01/2024 10/01/2024 24/10/2022 24/10/2022 https://clinicaltrials.gov/study/NCT05591560 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N Egypt Gynaecological Ovarian Epithelial Cancer Itraconazole Response rate; Biomarker; Other (specify) Other DB00602 N
NCT05318469 Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer RECRUITING Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Triple-Negative Breast Carcinoma DRUG: Ivermectin; DRUG: Balstilmab Incidence of adverse events, Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., From start of study treatment until 90 days after treatment completion; Objective response rate, Proportion of participants that are programmed cell death ligand 1 (PD-L1) negative with confirmed complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1., From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years. Yuan Yuan All ADULT, OLDER_ADULT 41 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT2022-07-YUAN-IB-TNBC 13/10/2023 10/01/2026 10/01/2026 04/08/2022 04/02/2024 https://clinicaltrials.gov/study/NCT05318469 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Ivermectin Safety and/or Dose; Response rate; PFS; OS; QoL Phase 2 DB01221 N
NCT04495894 Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma RECRUITING Non-small Cell Lung Cancer|Renal Cell Carcinoma DRUG: Preoperative Ketorolac Incidence of Blood Transfusion Among Ketorolac Group, Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as greater than two units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon., Prior to Hospital Discharge (generally up to 7 days post surgery); Incidence of Clinically Significant Hematoma Development Among Ketorolac Group, Significant hematoma development will be assessed among participants receiving ketorolac., Prior to Hospital Discharge (generally up to 7 days post surgery); Incidence of Return to the Operating Room for Bleeding Among Ketorolac Group, The need for returning to the operating room for bleeding, as determined by the treating surgeon, will be assessed among participants receiving ketorolac., Prior to Hospital Discharge (generally up to 7 days post surgery); Incidence of Postoperative Renal Failure Among Ketorolac Group, Postoperative renal failure among participants receiving ketorolac will be assessed., Prior to Hospital Discharge (generally up to 7 days post surgery); Incidence of Postoperative Morbidity Rate Among Ketorolac Group, Postoperative morbidity among participants receiving ketorolac will be assessed., Prior to Hospital Discharge (generally up to 7 days post surgery) Emory University All ADULT, OLDER_ADULT 76 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER STUDY00000205 24/08/2020 10/01/2024 10/01/2024 08/03/2020 24/10/2023 https://clinicaltrials.gov/study/NCT04495894 Localised/Locoregional Hospital/University/Research Institute Y N N United States Urological; Lung Renal Cell Carcinoma; Non-Small Cell Lung Cancer Ketorolac Safety and/or Dose Phase 1 DB00555 N
NCT04188119 A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer IMpALA NOT_YET_RECRUITING Breast Cancer DRUG: Avelumab; DRUG: Aspirin; DRUG: Lansoprazole 1. Mean combined gene expression of COX-2 tumour-promoting genes, 1. Mean combined gene expression of COX-2 tumour-promoting genes, in samples taken post treatment, 7 weeks The Christie NHS Foundation Trust Female ADULT, OLDER_ADULT 42 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT CFT / sp123; 2018-004121-80; 017NovCC107 12/01/2023 30/09/2024 31/05/2025 12/05/2019 17/05/2023 https://clinicaltrials.gov/study/NCT04188119 Localised/Locoregional Hospital/University/Research Institute Y N N United Kingdom Breast Breast Cancer - TNBC Acetylsalicylic Acid Biomarker Phase 2 DB01048 N
NCT03709446 Leflunomide in Previously Treated Metastatic Triple Negative Cancers RECRUITING Breast Neoplasms|Breast Diseases|Metastatic Triple Negative Breast Cancer DRUG: Leflunomide Maximum Tolerated Dose (MTD), 3+3 escalation schema. Patients will be enrolled in escalating cohorts of 3 patients per dose level until Dose-limiting Toxicity (DLT) (defined as any grade 3 or higher toxicity seen during the first 3-week cycle of leflunomide). If 0 of 3 patients are observed to have a DLT, the next 3 patients will be enrolled in the next higher dose level cohort. If 2/3 patients experience a DLT, escalation will stop and the previous dose will be defined as the MTD. If 1/3 experiences a DLT, three additional patients will be enrolled at the same dose level. If 2/6 patients experience a DLT, the next cohort of three patients will be treated at the next dose level. If 3/6 experience a DLT, the next lower dose level will define the MTD. If at the 50 mg dose/day if 0/3 or 2/6 patients experience a DLT, then that dose will define the MTD, 3 months; Clinical Benefit Rate (CBR), Response and progression to be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CBR = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) for at least 6 months duration, 6 months Joseph Sparano Female ADULT, OLDER_ADULT 54 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GCO 18-1832 16/04/2019 10/01/2025 10/01/2026 17/10/2018 30/05/2024 https://clinicaltrials.gov/study/NCT03709446 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Leflunomide Safety and/or Dose; Response rate; PFS Phase 1/2 DB00848 N
NCT03940378 Treatment of Advanced Intrahepatic Cholangiocarcinoma TAICC UNKNOWN ICC DRUG: Levamisole Hydrochloride; DRUG: Anlotinib Hydrochloride Capsules Progression-free Survival, Time from start of treatment until the first documented event of symptomatic progression or death., 24 months The First Affiliated Hospital of Zhengzhou University All ADULT, OLDER_ADULT 152 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT LEVICC-001 02/01/2019 02/01/2023 02/01/2023 05/07/2019 05/07/2019 https://clinicaltrials.gov/study/NCT03940378 Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N China GI Cholangiocaricnoma Levamisole PFS; OS Phase 3 DB01202 N
NCT01686126 Improving the Treatment for Women With Early Stage Cancer of the Uterus feMMe ACTIVE_NOT_RECRUITING Complex Endometrial Hyperplasia With Atypia|Grade 1 Endometrial Endometrioid Adenocarcinoma DRUG: Levonorgestrel; DRUG: Metformin Pathological complete response, 6 months Queensland Centre for Gynaecological Cancer Female ADULT, OLDER_ADULT 165 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT feMMe 12/01/2012 10/03/2022 12/01/2023 17/09/2012 18/04/2023 https://clinicaltrials.gov/study/NCT01686126 Localised/Locoregional Hospital/University/Research Institute N Y N Australia Gynaecological Endometrial Cancer Levonorgestrel; Metformin Response rate Phase 2 DB00130; DB00703 N
NCT04634539 Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer ACTIVE_NOT_RECRUITING Advanced Pancreatic Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Adenocarcinoma DRUG: Gemcitabine; DRUG: Nab-paclitaxel; DRUG: L-glutamine Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer., The number of dose-limiting toxicities (DLTs), defined as the rate of drug-related grade 3 adverse events (AEs) experienced within the first 4 weeks (1 cycle) of study treatment. The RP2D is defined as the dose level closest to the median of the posterior distribution of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of DLT at the MTD is =0.33., 4 weeks Jun Gong, MD All ADULT, OLDER_ADULT 18 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT2020-02-Gong-GLUTAPANC 13/05/2021 07/06/2023 07/06/2025 18/11/2020 06/04/2024 https://clinicaltrials.gov/study/NCT04634539 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer L-Glutamine Safety and/or Dose Phase 1 DB00281 N
NCT05833594 Whole-course Immunonutrition Combined With Chemoradiotherapy ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma RECRUITING Esophageal Squamous Cell Carcinoma|Chemoradiotherapy|Immunonutrition|Inoperable DIETARY_SUPPLEMENT: Whole-course Immunonutrition Combined With Chemoradiotherapy ICIs Rate of adverse events, Rate of adverse events (CTCAE V4.0), 1 month post treatment; Disease Control Rate, Disease Control Rate, 1 month post treatment Anhui Provincial Hospital All ADULT, OLDER_ADULT 70 OTHER_GOV Other Observational Model: |Time Perspective: p 2023WCIN001 07/01/2023 01/01/2026 12/01/2026 27/04/2023 26/12/2023 https://clinicaltrials.gov/study/NCT05833594 Localised/Locoregional Hospital/University/Research Institute Y N N China Head and Neck Throat Cancer L-Glutamine; Omega 3 Safety and/or Dose; Other (specify) Phase 2 DB00281; DB00338 N
NCT03134430 Effects of Regional Nerve Block on Cancer Recurrence UNKNOWN Cancer Patient OTHER: Normal saline; OTHER: peripheral Nerve block the effect of nerve block on the cancer recurrence rate and survival rate postoperation, to trace cancer recurrence after tumor resection with CT scaning and tumor biological maker test for 5 years, up to 5 years after surgery Luo Foquan All ADULT, OLDER_ADULT 400 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT LFoquan 07/10/2017 25/03/2018 05/01/2023 05/01/2017 25/05/2018 https://clinicaltrials.gov/study/NCT03134430 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Any solid tumours Lidocaine Recurrence rate Other DB08882 N
NCT03281369 A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) ACTIVE_NOT_RECRUITING Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma DRUG: 5-Fluorouracil (5-FU); DRUG: Leucovorin; DRUG: Oxaliplatin; DRUG: Atezolizumab; DRUG: Cobimetinib; BIOLOGICAL: Ramucirumab; DRUG: Paclitaxel; BIOLOGICAL: PEGylated recombinant human hyaluronidase (PEGPH20); DRUG: BL-8040; DRUG: Linagliptin; DRUG: Atezolizumab; DRUG: Cobimetinib; DRUG: Cisplatin; DRUG: Tiragolumab; DRUG: 5-Fluorouracil (5-FU) Percentage of Participants With Objective Response, as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1), From Randomization until disease progression or loss of clinical benefit (up to approximately 3-6 years); Percentage of Participants with Adverse Events (AEs), From first study treatment administration until 30 days after the last dose or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 3-6 years); For Arm 1L-A : Percentage of Participants with Serious and Non-serious Treatment-related AEs, During the safety run-in phase up to 28 days Hoffmann-La Roche All ADULT, OLDER_ADULT 410 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT YO39609; 2016-004529-17 13/10/2017 24/08/2024 30/04/2025 13/09/2017 05/01/2024 https://clinicaltrials.gov/study/NCT03281369 Advanced/Metastatic Company N Y N United States GI Gastric Cancer Linagliptin Safety and/or Dose; Response rate Phase 1/2 DB00279 N
NCT01669369 Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma Li2CO3 UNKNOWN Osteosarcoma DRUG: Lithium Carbonate; DRUG: Placebo progression-free survival,incidence of chemotherapy-induced myelosuppression, at least 24 months or at most 120 months Sun Yat-sen University All CHILD, ADULT, OLDER_ADULT 400 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT Lithium-5010 01/01/2013 12/01/2023 12/01/2023 21/08/2012 11/01/2016 https://clinicaltrials.gov/study/NCT01669369 Localised/Locoregional Hospital/University/Research Institute Y N Y China Bone Sarcoma Osteosarcoma Lithium PFS Phase 4 DB08827 N
NCT03153280 Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer Lithium ACTIVE_NOT_RECRUITING Colorectal Neoplasms|Stomach Neoplasm|Esophageal Neoplasms DRUG: Lithium; DRUG: Oxaliplatin; DRUG: Capecitabine Incidence of dose limiting toxicity (DLT) within the two first cycles at each dose level., The MTD will be based on the incidence of DLT within the two first cycles of lithium in combination with standard chemotherapy of oxaliplatin and capecitabine at each dose level., 26 months Cancer Trials Ireland All ADULT, OLDER_ADULT 2 NETWORK Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CTRIAL-IE (ICORG) 11-32; 2014-000186-47 13/01/2022 12/01/2024 12/01/2026 15/05/2017 13/10/2023 https://clinicaltrials.gov/study/NCT03153280 Advanced/Metastatic Collaborative Group N N N Ireland GI Colon Cancer; Rectal Cancer; Gastric Cancer; Esophageal Cancer Lithium Safety and/or Dose Phase 1 DB08827 N
NCT03563248 Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer ACTIVE_NOT_RECRUITING Pancreatic Cancer DRUG: FOLFIRINOX; DRUG: Losartan; DRUG: Nivolumab; RADIATION: SBRT; PROCEDURE: Surgery Proportion of participants with R0 resection, R0 resection is defined as microscopically negative margins determined by histopathologic assessment of the resection specimen. The R0 resection rate will be analyzed among all eligible patients, including those not resected due to early progression, death or off-study., Up to 8 months after baseline Massachusetts General Hospital All ADULT, OLDER_ADULT 168 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 18-179 08/10/2018 07/12/2022 06/01/2027 20/06/2018 09/08/2022 https://clinicaltrials.gov/study/NCT03563248 Localised/Locoregional Hospital/University/Research Institute Y Y N United States GI Pancreatic Cancer Losartan Other (specify) Phase 2 DB00227 N
NCT05097248 Camrelizumab in Combination With PLD and Losartan in Patients With TNBC Who Have Received 1 Line of Chemotherapy NOT_YET_RECRUITING Breast Cancer DRUG: Camrelizumab; DRUG: Liposomal Doxorubicin; DRUG: Losartan Objective Response Rate (ORR), ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: 30 decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, Estimated 12 months Wuhan Union Hospital, China Female ADULT, OLDER_ADULT 52 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT WHUH-BC-001 10/01/2021 10/01/2024 10/01/2024 28/10/2021 28/10/2021 https://clinicaltrials.gov/study/NCT05097248 Recurrent/Refractory Hospital/University/Research Institute N N N China Breast Breast Cancer - TNBC Losartan Response rate Phase 2 DB00227 N
NCT01821729 Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer UNKNOWN Pancreatic Cancer DRUG: FOLFIRINOX; DRUG: Losartan; RADIATION: Proton Beam Radiation Number of Participants With R0 Resection, The number of participants that received treatment with proton radiation along with FOLFIRINOX-Losartan and then subsequently underwent attempted surgery and achieved R0 resection. R0 resection means that no cancer cells were seen microscopically at the resection margin., At the time of surgery (approximately 4 months after the start of treatment) Massachusetts General Hospital All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 13-051 07/01/2013 07/01/2018 09/01/2021 04/01/2013 17/09/2019 25/09/2020 https://clinicaltrials.gov/study/NCT01821729 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Losartan Other (specify) Phase 2 DB00227 N
NCT03925662 Mebendazole as Adjuvant Treatment for Colon Cancer RECRUITING Colorectal Cancer DRUG: Folfox with avastin; DRUG: Mebendazole number of patients with tumour response, number of patients with response, 6 months Sherief Abd-Elsalam All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT colon cancer 04/01/2019 12/01/2028 12/01/2028 24/04/2019 24/04/2019 https://clinicaltrials.gov/study/NCT03925662 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Mebendazole Response rate Phase 3 DB00737 N
NCT04443049 To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma. UNKNOWN Hepatocellular Carcinoma|Liver Cirrhosis DRUG: Lenvatinib; DRUG: Mebendazole; OTHER: Placebo Overall survival in both groups, 15 months; Death, 2 year; Progressive disease requiring change of therapy in both groups, 2 year Institute of Liver and Biliary Sciences, India All ADULT, OLDER_ADULT 170 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT ILBS-Cirrhosis-32 07/10/2020 19/06/2022 19/06/2022 23/06/2020 10/05/2021 https://clinicaltrials.gov/study/NCT04443049 Advanced/Metastatic Hospital/University/Research Institute Y N N India GI Liver Cancer Mebendazole OS Other DB00737 N
NCT01430351 Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy ACTIVE_NOT_RECRUITING Glioblastoma|Gliosarcoma|Supratentorial Glioblastoma DRUG: Mefloquine; DRUG: Memantine Hydrochloride; DRUG: Metformin Hydrochloride; DRUG: Temozolomide Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, During first 28 days M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 144 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2011-0374; NCI-2011-03038; 2011-0374 14/09/2011 30/09/2025 30/09/2025 09/08/2011 02/12/2024 https://clinicaltrials.gov/study/NCT01430351 Any/All Stages Hospital/University/Research Institute Y Y N United States CNS Glioblastoma Mefloquine; Memantine; Metformin Safety and/or Dose Phase 1 DB00351; DB00170; DB00703 N
NCT05913427 Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC) PESETA RECRUITING Adrenocortical Carcinoma DRUG: Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG; DRUG: Etoposide, doxorubicin, cisplatin and Mitotane plus Placebo Evaluation of the activity of the combination regimen (EDP-M plus progesterone (EDP-MP) versus EDP-M plus placebo) in advanced/ metastatic patients with ACC., Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria between the 2 treatment arms., 18 months Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia All ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT ASSTBS-FARONCO- PESETA-20 06/08/2022 06/08/2027 06/08/2027 22/06/2023 22/06/2023 https://clinicaltrials.gov/study/NCT05913427 Advanced/Metastatic Hospital/University/Research Institute Y N N Italy Endocrine Adrenocortical Carcinoma Megestrol Acetate Response rate; Biomarker Phase 2 DB01065 N
NCT03777930 The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol UNKNOWN Cancer, Therapy-Related DRUG: Chemotherapy drugs; DRUG: thalidomide and megestrol acetate; OTHER: optimal support treatment; DRUG: thalidomide and megestrol acetate Imaging efficacy evaluation, Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI., before and 8 week after treatment Shenzhen Fifth People's Hospital All ADULT, OLDER_ADULT 200 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT shenzhenfifth 201807 12/10/2018 10/10/2020 06/10/2021 19/12/2018 19/12/2018 https://clinicaltrials.gov/study/NCT03777930 Advanced/Metastatic Hospital/University/Research Institute Y Y N China Multiple cancer types Any solid tumours Megestrol Acetate Response rate Phase 4 DB01065 N
NCT06007846 A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer RECRUITING Hepatocellular Carcinoma|Cirrhosis DRUG: Namenda Patients Progression Free Survival at 6 months, The response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. The progression of the disease is defined as at least a 20 increase in the sum of the Longest Diameter LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions or death due to disease without objective evidence of progression., 6 months from the start of treatment Inova Health Care Services All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT U23-01-4957 31/07/2023 31/08/2024 31/08/2025 23/08/2023 21/09/2023 https://clinicaltrials.gov/study/NCT06007846 Advanced/Metastatic Company N N N United States GI Liver Cancer Memantine PFS Phase 2/3 DB00170 N
NCT06162377 Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A Window of Opportunity Pilot Study. RECRUITING Head and Neck Squamous Cell Carcinoma DRUG: Methylnaltrexone Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year. M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2022-0729; NCI-2023-10299 01/10/2024 30/06/2024 30/06/2024 12/08/2023 01/12/2024 https://clinicaltrials.gov/study/NCT06162377 Any/All Stages Hospital/University/Research Institute N N N United States Head and Neck Oropharyngeal Cancer Methylnaltrexone Safety and/or Dose; Biomarker Phase 4 DB01233 N
NCT05343260 Impact of Anesthesia Maintenance Methods on 5-year Survival After Surgery UNKNOWN Aged|Neoplasms|Surgical Procedure, Operative|Anesthesia, Inhalation|Anesthesia, Intravenous|Survival DRUG: Sevoflurane; DRUG: Propofol Over survival after surgery., Time from surgery to the date of all-cause death., Up to 5 years after surgery Peking University First Hospital All OLDER_ADULT 1228 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION 2015[869]-3; ChiCTR-IPR-15006209 04/01/2015 29/09/2017 30/09/2022 25/04/2022 05/02/2022 https://clinicaltrials.gov/study/NCT05343260 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Any solid tumours Propofol OS; DFS/RFS/EFS; Recurrence rate Other DB00571 N
NCT05272462 Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer RECRUITING Ovarian Cancer DRUG: Minoxidil Overall response rate (ORR), The ORR is defined as the percentage of participants who experience a complete response (CR), partial response (PR), or stable disease (SD) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), At the end of Cycle 2 (each cycle is 28 days) Loyola University Female ADULT, OLDER_ADULT 34 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 214787 13/12/2021 31/12/2024 31/12/2024 03/09/2022 10/05/2023 https://clinicaltrials.gov/study/NCT05272462 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Ovarian Epithelial Cancer Minoxidil OS Phase 2 DB00370 N
NCT05968690 Naltrexone and Propranolol Combined With Immunotherapy RECRUITING Advanced Melanoma DRUG: Propranolol; DRUG: Naltrexone Safety as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, initial 28 days of treatment and then for up to 2 years; Dose-limiting toxicity of naltrexone in combination with propranolol and ipilimumab plus nivolumab, initial 28 days of treatment; Recommended phase 2 dose of naltrexone in combination with propranolol and ipilimumab plus nivolumab, up to 2 years from start of treatment Ryan Stephenson All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 092302; Pro2023001214; NCI-2023-06872 09/11/2023 30/09/2025 30/09/2025 08/01/2023 15/11/2023 https://clinicaltrials.gov/study/NCT05968690 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Skin Melanoma Naltrexone; Propranolol Safety and/or Dose; PFS; OS Phase 1 DB00788; DB00165 N
NCT04169763 Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery RECRUITING Stage II Vulvar Cancer AJCC v8|Stage III Vulvar Cancer AJCC v8|Stage IIIA Vulvar Cancer AJCC v8|Stage IIIB Vulvar Cancer AJCC v8|Stage IIIC Vulvar Cancer AJCC v8|Stage IVA Vulvar Cancer AJCC v8 DRUG: Cisplatin; RADIATION: External Beam Radiation Therapy; DRUG: Nelfinavir Recommended phase II dose (RP2D) of nelfinavir, Defined as the dose for which the isotonic estimate of the dose limiting toxicity (DLT) rate is closest to the target DLT rate of 30 . If there are ties, the higher dose will be chosen as the RP2D when the isotonic estimate is lower than 30 , and the lower dose will be chosen when the isotonic estimate is greater than or equal to 30 ., 1 year; Incidence of adverse events, Results from the dose escalation phase of study will be summarized by a tabulation of the number of patients treated and the number who experience a DLT at each dose level tested. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and administered dose level. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized. Will also report the number of patients who discontinue therapy and the reasons for discontinuation., 1 year M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 18 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2019-0629; NCI-2019-07570; 2019-0629 08/07/2020 31/12/2026 31/12/2026 20/11/2019 22/02/2024 https://clinicaltrials.gov/study/NCT04169763 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States Gynaecological Vulvar Cancer Nelfinavir Safety and/or Dose; PFS; OS Phase 1 DB00622 N
NCT03829020 Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma ACTIVE_NOT_RECRUITING Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma DRUG: Bortezomib; DRUG: Metformin Hydrochloride; DRUG: Nelfinavir Mesylate Maximum tolerated dose of the combination of metformin, nelfinavir, and bortezomib, Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients)., 42 days Mayo Clinic All ADULT, OLDER_ADULT 9 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MC1811; NCI-2019-00466; MC1811 17/04/2019 21/09/2022 08/01/2024 02/04/2019 09/07/2023 https://clinicaltrials.gov/study/NCT03829020 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Metformin; Nelfinavir Safety and/or Dose Phase 1 DB00703; DB00622 N
NCT05036226 COAST Therapy in Advanced Solid Tumors and Prostate Cancer COAST RECRUITING Prostate Cancer Recurrent|Solid Tumor, Adult COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus; COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus, Dasatanib; COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir; COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib; COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir; COMBINATION_PRODUCT: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib Maximum Tolerated Dose (MTD) - Phase I, Maximum dose achievable without dose limiting toxicities (DLT's), Minimum of 3 months after start of treatment on each dose level; Measure of proportion of patients with disease control - Phase II, Stable disease by RECIST or PCWG3 criteria after 16 weeks of treatment on study., Minimum of 16 weeks after start of treatment, per patient Medical University of South Carolina All ADULT, OLDER_ADULT 76 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 103352 03/03/2022 15/10/2024 15/10/2025 09/05/2021 20/03/2024 https://clinicaltrials.gov/study/NCT05036226 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Urological; Multiple cancer types Prostate Cancer; Any solid tumours Hydroxychloroquine; Metformin; Nelfinavir; Sirolimus Safety and/or Dose; QoL; Other (specify) Phase 1/2 DB07118; DB00703; DB00622; DB01261 N
NCT05188170 Niclosamide in Pediatric Patients With Relapsed and Refractory AML RECRUITING Acute Myeloid Leukemia (AML) DRUG: Niclosamide Dose-limiting toxicity, Dose-limiting toxicities (DLTs) are defined as any events Grade 3 that are at least possibly, probably, or definitely related to niclosamide treatment, 30 days Stanford University All CHILD, ADULT 16 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT IRB-61916; PEDSHEMAML0007; 641095; 6587-20 21/11/2022 07/01/2025 12/01/2026 01/12/2022 01/11/2024 https://clinicaltrials.gov/study/NCT05188170 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Leukemia Acute Lymphoblastic Leukemia, Childhood Niclosamide Safety and/or Dose; Response rate Phase 1 DB02701 N
NCT02807805 Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer ACTIVE_NOT_RECRUITING Metastatic Prostate Carcinoma|Recurrent Prostate Carcinoma|Stage IV Prostate Cancer DRUG: Abiraterone Acetate; DRUG: Niclosamide; DRUG: Prednisone PSA response rate, Percent of patients achieving greater than or equal to 50 PSA declines following initiation of treatment, Up to 2 years Mamta Parikh Male ADULT, OLDER_ADULT 37 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 871875; UCDCC#260; UCDCC#260; P30CA093373; NCI-2016-00779 10/01/2016 01/01/2024 07/01/2024 21/06/2016 29/11/2023 https://clinicaltrials.gov/study/NCT02807805 Localised/Locoregional; Recurrent/Refractory Company N N N United States Urological Prostate Cancer Niclosamide Safety and/or Dose; PFS; OS; Biomarker Phase 2 DB02701 N
NCT06049901 Nitazoxanide in Patients With Metastatic Colorectal Cancer RECRUITING Metastatic Colorectal Cancer DRUG: Nitazoxanide Investigating the possible efficacy of nitazoxanide through evaluation of its impact on overall response rate (ORR) and disease control rate (DCR)., Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR and DCR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. DCR includes patients with complete response, partial response and stable disease. Both ORR and DCR will be determined as number and percentage., 3 months; Evaluating the change in the serum level of Reduced glutathione (GSH), Blood samples will be collected at baseline and 3 months after treatment., 3 months; Evaluating the change in the serum level of Superoxide dismutase (SOD), Blood samples will be collected at baseline and 3 months after treatment., 3 months; Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB), Blood samples will be collected at baseline and 3 months after treatment., 3 months; Evaluating the change in the serum level of Protein disulfide isomerase (PDI), Blood samples will be collected at baseline and 3 months after treatment., 3 months Tanta University All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT Nitazoxanide in mCRC 03/01/2023 03/01/2025 03/01/2026 22/09/2023 22/09/2023 https://clinicaltrials.gov/study/NCT06049901 Adjuvant/Maintenance Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Nitazoxanide Response rate; DFS/RFS/EFS; Biomarker Phase 3 DB00348 N
NCT04930991 High Dose Omeprazole in Patients With Pancreatic Cancer OU202005AJ RECRUITING Exocrine Pancreatic Cancer DRUG: Omeprazole Proportion, Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery, 2 years; Safety and Tolerability, Frequency and severity of treatment related adverse events per CTCAE v5, 2 years University of Oklahoma All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT OU-SCC-Omeprazole 09/07/2021 06/01/2024 06/01/2025 18/06/2021 15/02/2024 https://clinicaltrials.gov/study/NCT04930991 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Pancreatic Cancer Omeprazole Biomarker Phase 1 DB01083 N
NCT06115174 Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer CRC - PTX NOT_YET_RECRUITING Metastatic Colorectal Carcinoma DRUG: Pentoxifylline; RADIATION: FOLFOX; RADIATION: XELOX; DRUG: Monoclonal antibodies (target therapy) Comparison of RECIST between the two groups., Difference in response rate (RECIST) between the control and drug groups., one year; Change in the serum concentration of the measured biological markers., one year; Difference in progression free survival 'PFS' between the two groups, One year.; Difference in overall survival 'OS' between the two groups., One year. Tanta University All ADULT, OLDER_ADULT 44 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER Pentoxiphylline in CRC 11/01/2023 11/01/2024 12/01/2024 11/02/2023 11/02/2023 https://clinicaltrials.gov/study/NCT06115174 Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Pentoxifylline Response rate; PFS; OS Phase 4 DB08883 N
NCT02451774 Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction PTX-II UNKNOWN Acute Lymphoblastic Leukemia DRUG: Pentoxifylline Plus Chemotherapy; DRUG: Placebo Plus Chemotherapy Apoptosis measure by Flow Cytometry, Percentage of apoptotic cells by Flow Cytometry, Up to 28 days after initiation of chemotherapy for remission induction Ram n scar Gonz lez-Ramella, Ph.D All CHILD, ADULT 44 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT IICIA -PTX02 01/01/2015 12/01/2019 12/01/2020 22/05/2015 05/09/2018 https://clinicaltrials.gov/study/NCT02451774 Localised/Locoregional Hospital/University/Research Institute Y N Y Mexico Leukemia Acute Lymphoblastic Leukemia, Childhood Pentoxifylline Safety and/or Dose; Biomarker Phase 2/3 DB08883 N
NCT03778996 SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma HopES ACTIVE_NOT_RECRUITING Sarcoma, Ewing|Sarcoma DRUG: Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) Overall Response Rate, Complete response (CR) + partial response (PR) as evaluated using RECIST 1.1, Every 3 months for up to 2 years; Stable Disease for at Least 3 Months, Stable disease (SD) as evaluated using RECIST 1.1, Every 3 months for up to 2 years; Progression Free Survival on Study of at Least 1.5 Times the Duration of PFS for the Last Prior Treatment, From date of enrollment until the date of first documented progression, as evaluated using RECIST 1.1, or date of death, whichever occurs first, Every 3 months for up to 2 years Sarcoma Oncology Research Center, LLC All CHILD, ADULT, OLDER_ADULT 31 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT SM-88-JAF-16 01/03/2020 19/12/2024 31/03/2025 19/12/2018 18/04/2024 https://clinicaltrials.gov/study/NCT03778996 Advanced/Metastatic; Recurrent/Refractory Collaborative Group N N N United States Bone Sarcoma; Soft Tissue Sarcoma Ewing Sarcoma; Any Bone Sarcomas; Any soft tissue sarcoma Phenytoin; Sirolimus Response rate Phase 2 DB01100; DB01261 N
NCT03177291 Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC ACTIVE_NOT_RECRUITING Lung Cancer|Non Small Cell Lung Cancer|Advanced Cancer|Metastatic Lung Cancer|Squamous Cell Lung Cancer|Non-Squamous Non-Small Cell Neoplasm of Lung DRUG: Pirfenidone; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Pemetrexed Phase 1: Recommended Phase 1b Dose, Recommended Phase 1b dose of Pirfenidone in combination with standard first-line chemotherapy, based on Dose Limiting Toxicity (DLT) from phase 1. Dose-limiting Toxicity: The occurrence of any of the following toxicities will be considered a DLT, if judged by the Investigator to be possibly, probably, or definitely related to study drug administration, referring to grade 3-5 adverse events as listed in the protocol document., 6 months post final enrollment in phase 1 - up to 48 months; Phase 1b: Overall Response Rate (ORR), ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete Response (CR) plus Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response (PR): At least a 30 decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters., 6 months post final enrollment in phase 1b - up to 48 months H. Lee Moffitt Cancer Center and Research Institute All ADULT, OLDER_ADULT 48 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT MCC-19082 26/09/2017 05/09/2021 06/01/2024 06/06/2017 22/02/2024 https://clinicaltrials.gov/study/NCT03177291 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Lung Non-Small Cell Lung Cancer Pirfenidone Safety and/or Dose; Response rate; PFS; OS Phase 1 DB00554 N
NCT06142318 Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma RECRUITING Head and Neck Squamous Cell Carcinoma|Radiotherapy|Radiosensitizer|Pirfenidone DRUG: Pirfenidone; DRUG: Placebo Objective response rate (ORR), The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30 compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20 , and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD., 1 month Nanfang Hospital, Southern Medical University All ADULT, OLDER_ADULT 66 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT NFEC-2023-477 15/11/2023 30/01/2025 30/06/2025 21/11/2023 21/11/2023 https://clinicaltrials.gov/study/NCT06142318 Localised/Locoregional Hospital/University/Research Institute Y N N China Head and Neck Any head and neck squamous cell carcinoma Pirfenidone Safety and/or Dose; Response rate; OS Phase 2 DB00554 N
NCT04467723 Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC RECRUITING NSCLC Stage IV|NSCLC, Recurrent DRUG: Atezolizumab Occurrence of Grade 3 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days); Occurrence of Grade 4 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) University of Kansas Medical Center All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT-2020-CAFs 18/05/2022 08/01/2024 08/01/2025 13/07/2020 09/11/2023 https://clinicaltrials.gov/study/NCT04467723 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Pirfenidone Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00554 N
NCT01988831 Efficacy of Propranolol Treatment to Prevent Melanoma Progression SUSPENDED Stages III Skin Melanoma|Stages II Skin Melanoma|Stage IB Skin Melanoma DRUG: Propranolol hydrochloride; DRUG: Placebo pill Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence, The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease.We will measure the efficacy of a propranolol treatment on the risk of progression of the disease., five years University Hospital, Geneva All ADULT, OLDER_ADULT 450 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT HUG-MEL-BB 06/01/2016 01/01/2022 03/01/2022 20/11/2013 05/10/2019 https://clinicaltrials.gov/study/NCT01988831 Localised/Locoregional Hospital/University/Research Institute Y N N Switzerland Skin Melanoma Propranolol PFS; OS; Biomarker Phase 2 DB00165 N
NCT06145074 Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC. IMPULS RECRUITING Pancreatic Cancer|Surgery DRUG: Propranolol; DRUG: Placebo Preoperative anxiety, Assessed through the Hamilton Anxiety Rating Scale (HAMA) questionnaire, Obtained preoperatively at baseline (immediately after inclusion) and immediately after intervention (before surgery); Preoperative anxiety and depression, Assessed through the Hospital Anxiety and Depression Scale (HADS) questionnaire, Obtained preoperatively at baseline (immediately after inclusion) and immediately after intervention (before surgery); Preoperative quality of life, Preoperative quality of life assessed through the quality of life questionnaire., Obtained preoperatively at baseline (immediately after inclusion) and immediately after intervention (before surgery); Density and subtypes of tumor-infiltrating lymphocytes in the tumor microenvironment., Histopathological assessment of the density and subtypes of tumor-infiltrating lymphocytes.Immunohistochemistry technique will be used., Through study completion. At latest within 1 year from last participant completes trial.; Desmoplasia in the tumor microenvironment., Histopathological assessment of desmoplasia in the tumor microenvironment.Immunohistochemistry technique will be used., Through study completion. At latest within 1 year from last participant completes trial.; Neural markers in the tumor microenvironment., Histopathological assessment of neural marker expression (e.g., NGF, BDNF, tyrosin hydroxylase)Immunohistochemistry technique will be used., Through study completion. At latest within 1 year from last participant completes trial.; Adrenergic receptor (ADRB1 ADRB2) expression in the tumor microenvironment., Histopathological assessment of the expression of adrenergic receptors (ADRB1 and ADRB2).Immunohistochemistry technique will be used for this purpose., Through study completion. At latest within 1 year from last participant completes trial.; Spatial distribution of immune cells in the tumor microenvironment., Spatial distribution of immune cells in the tumor microenvironment using Immunohistochemistry technique and NanoString GeoMx techniques will be used for this purpose., Through study completion. At latest within 1 year from last participant completes trial.; Immune cells and subtypes in blood samples, Assessing the number and subsets of immune cells in the obtained blood samples before and after propranolol treatment and between the two arms (propranolol versus placebo). This will be examined through FlowCytometry., Through study completion. At latest within 1 year from last participant completes trial.; Circulating tumor cells before and after intervention in blood samples., Assessment of circulating tumor cells in blood samples before and after intervention., Through study completion. At latest within 1 year from last participant completes trial.; RNA-level gene expression in blood samples., RNA-level expression of genes related to immune-surveillance through NanoString nCounter technique., Through study completion. At latest within 1 year from last participant completes trial.; Heart rate variability in both trial arms, Examining differences in heart rate variability among participants and between intervention and comparator group., Through study completion, an average of 1 year.; Postoperative complications, Assessment of postoperative complications based on the Clavien-Dindo Score (CD) ranging from I to V, where I is any decline from normal postoperative course and V is death of patient., After participant finishes trial and when last follow up (5 years from surgery) date is due.; Survival 30-days after surgery, Assessment of survival 30 days after surgery., After participant finishes trial and when last follow up (5 years from surgery) date is due.; Survival 90-days after surgery, Assessment of survival 90 days after surgery., After participant finishes trial and when last follow up (5 years from surgery) date is due.; Overall survival 1-year after surgery, Assessment of overall surival 1-year after surgery, After participant finishes trial and when last follow up (5 years from surgery) date is due.; Overall survival 3-years after surgery, Assessment of overall survival 3-years after surgery, After participant finishes trial and when last follow up (5 years from surgery) date is due.; Overall survival 5-years after surgery, Assessment of overall survival 5-years after surgery, After participant finishes trial and when last follow up (5 years from surgery) date is due. Zealand University Hospital All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT EU CT 2023-506553-37-00 20/03/2024 31/12/2026 31/12/2035 22/11/2023 28/03/2024 https://clinicaltrials.gov/study/NCT06145074 Localised/Locoregional Hospital/University/Research Institute Y N N Denmark GI Pancreatic Cancer Propranolol OS; Biomarker Phase 2 DB00165 N
NCT04005365 Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer UNKNOWN Gastric Cancer DRUG: Propranolol ORR, CR+PR, Preoperative assessment Yijing He All ADULT, OLDER_ADULT 78 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2019/prop/GC/CSU 20/11/2019 06/01/2020 06/01/2020 07/02/2019 26/11/2019 https://clinicaltrials.gov/study/NCT04005365 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N China GI Gastric Cancer Propranolol Response rate Phase 2 DB00165 N
NCT05678348 Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma RECRUITING Head and Neck Cancer|Cancer of the Head and Neck DRUG: Pyrimethamine Change in Log2 of tumor DHFR expression as measured by western blot analysis, Pre-treatment and post-treatment (estimated to be 14 days) Washington University School of Medicine All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 202302068 08/03/2023 15/04/2026 15/04/2026 01/10/2023 22/04/2024 https://clinicaltrials.gov/study/NCT05678348 Localised/Locoregional Hospital/University/Research Institute N N N United States Head and Neck Any head and neck squamous cell carcinoma Pyrimethamine Safety and/or Dose; Biomarker; Other (specify) Phase 1 DB12975 N
NCT05291390 Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) UNKNOWN Acute Myeloid Leukemia (AML)|Acute Lymphoblastic Leukemia (ALL) DRUG: Pyronaridine Tetraphosphate Change in survival lengths to 1 year, The primary endpoint is the change in survival lengths in days between the study arm receiving pyronaridine and the study arm receiving placebo as measured from the date of the first known acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) diagnosis within 60 days of the time of study entry., 1 year Armaceutica, Inc. All ADULT, OLDER_ADULT 200 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT PND7351 21/11/2022 02/01/2024 03/01/2024 22/03/2022 29/11/2022 https://clinicaltrials.gov/study/NCT05291390 Localised/Locoregional Company Y N N United States Leukemia Acute Lymphoblastic Leukemia, Adult; Acute Myeloid Leukemia, Adult Pyronaridine OS Phase 2 DB06816 N
NCT01303341 Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma ACTIVE_NOT_RECRUITING Advanced Malignant Solid Neoplasm|Recurrent Melanoma|Refractory Malignant Solid Neoplasm|Stage III Cutaneous Melanoma AJCC v7|Stage IIIA Cutaneous Melanoma AJCC v7|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7 OTHER: Laboratory Biomarker Analysis; OTHER: Pharmacological Study; DRUG: Riluzole; DRUG: Sorafenib Tosylate Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors, Maximum tolerated dose is defined as the first dose level at which exactly 2/6 patients experience dose limiting toxicity, or at which 1/6 experience dose limiting toxicity and (due to de-escalation) at least 2/3 or 3/6 patients treated with the next higher dose level had dose limiting toxicity., 28 days National Cancer Institute (NCI) All ADULT, OLDER_ADULT 35 NIH Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCI-2011-02597; NCI-2011-02597; CDR0000695355; 090906; 8850; 8850; P30CA072720; R01CA149627; U01CA132194; UM1CA186716 18/02/2011 05/01/2012 09/09/2024 24/02/2011 07/03/2024 https://clinicaltrials.gov/study/NCT01303341 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin; Multiple cancer types Melanoma; Any solid tumours Riluzole Safety and/or Dose; Biomarker Phase 1 DB00884 N
NCT04761614 Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer ACTIVE_NOT_RECRUITING Metastatic Colorectal Carcinoma|Stage IV Colorectal Cancer AJCC v8|Stage IVA Colorectal Cancer AJCC v8|Stage IVB Colorectal Cancer AJCC v8|Stage IVC Colorectal Cancer AJCC v8 BIOLOGICAL: Bevacizumab; DRUG: Fluorouracil; DRUG: Leucovorin Calcium; DRUG: Oxaliplatin; DRUG: Riluzole Dose limiting toxicities (DLTs), Will be defined by treatment related grade \>= 4 adverse events or \>= grade 3 alanine aminotransferase or aspartate aminotransferase elevation during the DLT period using the Common Terminology Criteria for Adverse Events version 5.0., Up to 4 weeks (2 cycles of treatment) (1 cycle = 14 days) Ning Jin All ADULT, OLDER_ADULT 13 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT OSU-20096; NCI-2021-00018 04/02/2021 05/06/2023 31/12/2024 21/02/2021 16/05/2024 https://clinicaltrials.gov/study/NCT04761614 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Colon Cancer; Rectal Cancer Riluzole Safety and/or Dose; Other (specify) Phase 1 DB00884 N
NCT04114136 Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies RECRUITING Melanoma|NSCLC|Hepatocellular Carcinoma|Urothelial Cancer|Gastric Adenocarcinoma|HNSCC|Esophageal Adenocarcinoma|Microsatellite Instability-High Solid Malignant Tumor DRUG: Nivolumab or Pembrolizumab (dependent upon approved indication); DRUG: Metformin; DRUG: Rosiglitazone Best overall response, Best overall response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), by tumor type, recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): 30 decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Incomplete Response/Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, (reference smallest sum diameters). Progressive Disease (PD): 20 increase in the sum of diameters of target lesions (reference smallest sum diameters); the sum must also demonstrate an absolute increase of at least 5 mm; (appearance 1 new lesions is considered progression)., From start of the treatment until disease progression/recurrence up to 48 months Dan Zandberg All ADULT, OLDER_ADULT 72 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT HCC 18-190 14/09/2020 30/04/2032 30/04/2032 10/03/2019 02/07/2024 https://clinicaltrials.gov/study/NCT04114136 Advanced/Metastatic Hospital/University/Research Institute Y Y N United States Multiple cancer types Multiple cancer types Metformin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00703 N
NCT02664935 National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer ACTIVE_NOT_RECRUITING Non-Small Cell Lung Cancer|Carcinoma, Squamous Cell|Adenocarcinoma DRUG: AZD4547; DRUG: Vistusertib; DRUG: Palbociclib; DRUG: Crizotinib; DRUG: Selumetinib; DRUG: Docetaxel; DRUG: AZD5363; DRUG: Osimertinib; DRUG: Durvalumab; DRUG: Sitravatinib; DRUG: AZD6738 Objective response (OR), CT scans every 6 weeks from baseline until disease progression (Primary outcome for all Trial Arms except Arm C). Investigators expect patients to participate in the study for a maximum of 18 months, however cannot guarantee that some patients may participate over 18 months., From baseline until disease progression, assessed up to 18 months.; Progression-free survival time (PFS), Defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression (Primary Outcome for Arm C only). Patients who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression. Investigators expect patients to participate in the study for a maximum of 18 months, however, cannot guarantee that some patients may participate over 18 months., From date of commencement of trial treatment to date of CT scan when progressive disease first recorded or date of death without previously recorded progression, assessed up to 18 months.; Durable clinical benefit (DCB), A patient will be defined as experiencing DCB if they remain free of disease progression at their fourth CT or MRI scan since treatment start date, i.e. approximately 24 weeks, or at any scan after 24 weeks that shows the patient free of disease progression (co-primary outcome for all Trial Arms except Arm C \ G), From baseline until the first scan after 24 weeks showing the patient free of disease progression. University of Birmingham All ADULT, OLDER_ADULT 423 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT RG_14-072; 2014-000814-73; ISRCTN38344105 05/01/2015 09/01/2024 09/01/2024 27/01/2016 13/05/2024 https://clinicaltrials.gov/study/NCT02664935 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United Kingdom Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose; Response rate; PFS; OS; Biomarker Phase 2 DB01104 N
NCT03324425 Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer SIMPHONY ACTIVE_NOT_RECRUITING Breast Cancer Stage IV DRUG: Simvastatin 80mg Objective Response, Objective response is defined as complete response or partial response, according to RECIST criteria., Up to approximately 24 months Baylor Breast Care Center Female ADULT, OLDER_ADULT 5 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT H-41818 03/04/2020 12/01/2028 12/01/2030 27/10/2017 16/01/2024 https://clinicaltrials.gov/study/NCT03324425 Advanced/Metastatic Hospital/University/Research Institute N N N United States Breast Breast Cancer - HER2+ Simvastatin Safety and/or Dose; Response rate; Biomarker Phase 2 DB00877 N
NCT02161822 Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients UNKNOWN Adenocarcinoma of Rectum DRUG: simvastatin pathologic complete response rate, pathologic complete response ratewill be shown with 95 confidence intervals, average of 5 weeks Samsung Medical Center All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2014-03-056 10/01/2014 12/01/2020 12/01/2020 06/12/2014 25/03/2020 https://clinicaltrials.gov/study/NCT02161822 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N Korea, Republic of GI Rectal Cancer Simvastatin Safety and/or Dose; Response rate; OS; Biomarker; Other (specify) Phase 2 DB00877 N
NCT04985201 Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy UNKNOWN Small Cell Lung Cancer DRUG: Irinotecan; DRUG: Simvastatin Progression-free survival (PFS), To evaluate the progression-free survival (PFS) of patients., 12 weeks Shanghai Pulmonary Hospital, Shanghai, China All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2020LY025 11/01/2021 12/01/2022 08/01/2023 08/02/2021 08/09/2021 https://clinicaltrials.gov/study/NCT04985201 Advanced/Metastatic Hospital/University/Research Institute Y N N China Lung Small Cell Lung Cancer Simvastatin Safety and/or Dose; Response rate; PFS; OS Phase 2 DB00877 N
NCT03086291 A Phase I Study of High Dose Simvastatin in Patients With Gastrointestinal Tract Cancer Who Failed to Standard Chemotherapy UNKNOWN Stomach Cancer DRUG: Simvastatin maximum tolerated dose, maximum tolerated dose, 12months Samsung Medical Center All ADULT, OLDER_ADULT 9 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2017-02-138 01/04/2018 09/01/2020 12/01/2020 22/03/2017 30/12/2019 https://clinicaltrials.gov/study/NCT03086291 Recurrent/Refractory Hospital/University/Research Institute N N N Korea, Republic of GI Gastric Cancer; Colon Cancer; Rectal Cancer Simvastatin Safety and/or Dose Phase 1 DB00877 N
NCT05947825 Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients NOT_YET_RECRUITING PDAC - Pancreatic Ductal Adenocarcinoma DRUG: Combination of sitagliptin+ gemcitabine + nab-paclitaxel Progression-free survival time, Rrogression-free survival time of PDAC patients, from start of treatment until progression or last known follow up (i.e up to 2 years) Tianjin Medical University Cancer Institute and Hospital All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT Sitagliptin plus AG-Tianjin 30/07/2023 08/01/2024 08/01/2024 17/07/2023 17/07/2023 https://clinicaltrials.gov/study/NCT05947825 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Pancreatic Cancer Sitagliptin Safety and/or Dose; Response rate; PFS; OS Phase 2 Not found in DrugBank N
NCT05664464 Glutamate Inhibitors in Glioblastoma GLUGLIO RECRUITING Glioblastoma DRUG: Gabapentin; DRUG: Sulfasalazine; DRUG: Memantine; DRUG: Temozolomide; RADIATION: Radiotherapy PFS-6, progression-free survival at 6 months, 6 months University of Zurich All ADULT, OLDER_ADULT 120 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2022-01877 01/01/2023 06/01/2026 12/01/2026 23/12/2022 05/10/2024 https://clinicaltrials.gov/study/NCT05664464 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Switzerland CNS Glioblastoma Memantine; Sulfasalazine PFS Ph