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 DB00244 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 DB11689 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 DB01202 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 DB00338; DB00641 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 DB00126 N
ACTRN12623001164684 Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for cancer: The ReDO cancer treatment study 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; 14/10/2024 09/11/2023 28/10/2024 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 DB01076; DB00608; DB00975; DB00254; DB01275; DB01167; DB01601; Not found in DrugBank; DB00351; DB00244; DB00692 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 DB01275 N
IRCT20230903059342N2 Investigating the treatment of ovarian cancer by optimized measles vaccine Recruiting Ovarian cancer.
Malignant neoplasm of ovary Intervention 1: Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine that designed and optimized by Baqiyatullah university intraperitoneally in four doses with an interval of two weeks for each dose. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy with cisplatin and immunotherapy with Avastin. In fact, the intervention is in the form of adjuvant therapy. Intervention 2: Control group: patients who receive only standard treatment including chemotherapy with Cisplatin and immunotherapy with Avastin. Fever. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: Thermometer.;Examining changes in the patient's heart condition. Timepoint: Hourly after the start of treatment for up to 7 days. Method of measurement: Electrocardiogram.;Examining changes in the patient's breathing status. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: pulse oximeter.;Examining the amount of ca 125 cancer antigen in the blood. Timepoint: Weekly until 3 months after the end of treatment. Method of measurement: Blood test.;Examination of tumors of the abdominal cavity. Timepoint: Weekly until 3 months after the end of treatment. Method of measurement: Sonography. Kian Gen Azma Company Female 18 years - 70 years 15 Kian Gen Azma Company Interventional Study Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is going to be done by the method of random blocks of 6 random strings with a length of 15 coincidences with a ratio of 2 to 1. This string is created by one of the online randomization software. In order to hide the randomization, the method of closed envelopes will be used. 22/12/2023 28/12/2023 22/01/2024 http://en.irct.ir/trial/72668 Localised/Locoregional Company Y N N Iran Gynaecological Ovarian - Other; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor Measles vaccine Biomarker Phase 1 DB04835 N
CTRI/2024/01/061661 To Study effectiveness of oral chemotherapy with low dose immunotherapy compared with chemotherapy in Head and Neck Cancer Patients Not Yet Recruiting Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Intervention1: Triple metronomic chemotherapy with low dose nivolumab: Patients allotted to the intervention arm will receive triple metronomic chemotherapy with low dose nivolumab . TMC will consist of capsule celecoxib 200 mg twice daily, weekly methotrexate 9 mg per m2 once a week, and erlotinib 150 mg once daily, all administered orally. In addition, patients with receive intravenous nivolumab 20 mg administered in 100 mL normal saline over 60 minutes once every 3 weeks. A 21-day period will be considered a cycle . Till disease progression
Control Intervention1: Cisplatin or carboplatin and paclitaxel: cisplatin 75 mg per m2 day 1 or Carboplatin area under the curve AUC 6 and paclitaxel 175 mg per m2 over 3hours on day 1 will be administered every 3 weeks till progression.
To assess if TMCI results in a non-inferior OS as compared to platinum-based combination chemotherapy in patients with advanced unresectable or metastatic HNSCC that is platinum-sensitive in the first line palliative settingTimepoint: till 5 years Tata Memorial Centre - - 422 Tata Memorial Centre OPD No 204 2nd floor Homi Bhabha Block Dr E Borges Marg Parel Mumbai Interventional Study Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label version 2.0 dated 12.10.23 01/02/2024 19/01/2024 29/04/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=98576 Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Any head and neck squamous cell carcinoma Celecoxib OS Phase 3 DB00482 N
CTRI/2024/01/061073 Study of 2 different type of chemotherapy in Head and Neck Cancer Patients Not Yet Recruiting Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Intervention1: Arm A € Paclitaxel plus Carboplatin (Chemotherapy)
Arm B - Paclitaxel plus Carboplatin (Chemotherapy) with Tab Celecoxib 200 mg PO twice daily, erlotinib
(150 mg PO OD) plus Tab Methotrexate 9 mg/m2 weekly ( D1,D8,D15) with chemotherap: Arm A: Patients on arm A will initially receive Paclitaxel (175 mg/m2) plus Carboplatin (AUC 5) on day 1 in 3
weekly cycles.
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: Arm A € Paclitaxel plus Carboplatin (Chemotherapy)
Arm B - Paclitaxel plus Carboplatin (Chemotherapy) with Tab Celecoxib 200 mg PO twice daily, erlotinib
(150 mg PO OD) plus Tab Methotrexate 9 mg/m2 weekly ( D1,D8,D15) with chemotherapy: Arm A will initially receive Paclitaxel (175 mg/m2) plus Carboplatin (AUC 5) on day 1 in 3 weekly cycles.
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
Intervention3: Paclitaxel plus Carboplatin (Chemotherapy)
: Patients on arm A will initially receive Paclitaxel on day 1 in 3 weekly cycles. Maximum 6 cycles would be administered
Control Intervention1: Paclitaxel plus Carboplatin (Chemotherapy) and Tab Celecoxib ,erlotinib Tab Methotrexate and Tab Eroltinib: Patients on arm B will initially receive Paclitaxel plus Carboplatin (Chemotherapy) and Tab Celecoxib ,Tab Methotrexate and Tab Eroltinib weekly ( D1,D8,D15) with chemotherapy.
Paclitaxel -Carboplatin : Maximum 6 cycles would be administered.
Methotrexate, erlotinib and celecoxib : Will b To compare the Overall Survival between the armsTimepoint: 5 years Tata Memorial Hospital - - 184 Tata Memorial HospitalDr E Borges Road Parel Mumbai 400012 Interventional Study Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label 4141;Version 2.0 Dated 16th Oct 2023 08/01/2024 02/01/2024 22/01/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=96921 Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Any head and neck cancer Celecoxib OS Phase 4 DB00482 N
NL-OMON46294 Immune protective anesthesia during endoscopic colon surgery to improve long-term survival Pending
immune system
narcosis;10027665;10017991;immune system;narcosis Patients will be randomized in two groups:
1. Conventional anesthesia:
- Preopartive Paracetamol
- Intravenous analgesia with opioids and postoperative pain management with
Dipidolor or morphine according to local protocols.
- Anesthesia only with Sevoflurane; dosage according to the bispectral index
scale (BIS) with target values between 40 and 60.
- Ketamine, Clonidine and Dexamethason according to the judgment of the
anesthesiologist.
- No Dexmedetomidine, epidurale analgesia, continueous lidocaine or COX-2
inhibitor.
2. Immune protective regime:
- Single dose of preoperative Paracetamol and Midazolam (dosage according to
anesthesiologist)
- Analgesia perioperative: epidural (only with local anesthetic), Paracetamol,
Dexmedetomidine (between 0.2 and 1.0 ug/kg/hr without any bolus) starting
before epidural
- Analgesia postoperative: epidurale analgesia according to local protocols
(only with local anesthetic) and Paracetamol
- Anesthesia only with Propofol; dosage according to the bispectral index scale
(BIS) with target values between 40 and 60.
- Without peri- or postoperative use of opiates, Ketamine, Clonidine or
Dexamethason
- Hypotension should preferably be treated with phenylephrine
;anesthesia;immune-response;metastases;oncology Primary study parameters:
immunological response 24hr-postoperative
Anesthesiologie - 18 - 64 366 Ministerie van OC W Interventional Study Randomized controlled trial, Open (masking not used), Parallel, Prevention 2017-000867-34;NL58206.056.17 06/01/2017 23/10/2017 28/02/2024 https://onderzoekmetmensen.nl/en/trial/46294 Localised/Locoregional Local/National government Y N N Netherlands GI Colon Cancer Propofol Biomarker Not available/Missing DB00818 N
NL-OMON33441 Phase I study of nelfinavir in combination with temsirolimus in the treatment of patients with advanced cancers, including second line renal cell cancer Pending
advanced cancer
metastatic cancer;10027655 Treatment with BID nelfinavir orally
Treatment with weekly temsirolimus intravenously
Blood sampling
- pharmacokinetics (steady state concentration) and toxicity/feasibility of
the combination of temsirolimus and nelfinavir
Academisch Medisch Centrum - 18 - 99 21 Ministerie van OC W;Wyeth;Wyeth Pharmaceuticals BV;Spicalaan 31;2132 JG Hoofddorp Interventional Study Open (masking not used), Uncontrolled, Treatment EUCTR2008-007774-38-NL;NL26658.018.09 03/01/2009 29/04/2009 05/06/2024 https://onderzoekmetmensen.nl/en/trial/33441 Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands Multiple cancer types Multiple cancer types Nelfinavir Safety and/or Dose Not available/Missing DB00788 N
ChiCTR2400081288 A multicenter, single-arm, phase II clinical study of the efficacy and safety of oral atorvastatin combined with temozolomide in the treatment of glioblastoma Pending Glioblastoma Atorvastatin administrating group:According to the clinical standard dose of lipid-lowering drugs, the included subjects took 1 tablet of Lipitor orally every night after 2 weeks of glioma surgery, on the basis of other treatments.
; Progression-free survival;Overall survival;Tumor control rate; Tianjin Medical University General Hospital All 18 - 60 Atorvastatin administrating group:50; Ministry of Science and Technology (2023YFC2510000) Interventional Study Single arm 03/01/2024 28/02/2024 03/04/2024 https://www.chictr.org.cn/showproj.html?proj=221078 Localised/Locoregional Hospital/University/Research Institute N N N China CNS Glioblastoma Atorvastatin Response rate; PFS; OS Phase 2 DB01076 N
JPRN-jRCT2031230531 A Phase I study of Oxyfedrine and Sulfasalazine in Patients with Solid Tumor Recruiting advanced or recurrent solid tumor unresectable and unresponsive to conventional therapy (Dose-escalation part)
Tolerability of combination therapy with Oxyfedrine and Sulfasalazine in the dose-escalation part will be assessed, and the recommended dose (RD) in the dose-expansion part will be determined.
The doses of Oxyfedrine and Sulfasalazine will start at dose level 1a and move to dose level 2, dose level 3 or dose level -1 according to the criteria.
Level 1a : Sulfasalazine 6 g/day, Oxyfedrine 24 mg/day
Level 1b : Sulfasalazine 6 g/day, Oxyfedrine 48 mg/day
Level 2a : Sulfasalazine 8 g/day, Oxyfedrine 24 mg/day
Level 2b : Sulfasalazine 8 g/day, Oxyfedrine 48 mg/day
Oxyfedrine and Sulfasalazine will be administered orally 4 times a day.One cycle is defined as 4 weeks.
(Dose-expansion part)
The RD determined on the results of the dose-escalation part will be administered. Incidence of DLTs in the dose-escalation part Kohei Shitara All >= 18age old - Not applicable 54 Japan Agency for Medical Research and Development;FerroptoCure Inc. Interventional Study single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose 15/01/2024 22/12/2023 04/01/2024 https://jrct.niph.go.jp/latest-detail/jRCT2031230531 Recurrent/Refractory Hospital/University/Research Institute N N N Japan Breast; GI Breast Cancer - TNBC; Renal Cell Carcinoma; Gastric Cancer Sulfasalazine Safety and/or Dose Phase 1 DB00605 N
ChiCTR2400082375 A Phase Ib Study on the Safety and Feasibility of Combined Therapy with Sildenafil, Tirelizumab, and Platinum-Containing Double Drugs as First-Line Treatment for Advanced Lung Adenocarcinoma Pending Advanced lung adenocarcinoma Experimental group:Sildenafil in addition to tirelizumab and pemetrexed plus Carboplatin chemotherapy; Non-hematological Toxicities;Hematological Toxicities; Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital Male 18 - 99 Experimental group:10; Self-funded Interventional Study Single arm 04/01/2024 27/03/2024 04/01/2024 https://www.chictr.org.cn/showproj.html?proj=223378 Advanced/Metastatic Hospital/University/Research Institute N N N China Lung Non-Small Cell Lung Cancer Sildenafil Safety and/or Dose; Response rate; PFS; OS Phase 1 DB00203 N
CTRI/2024/03/063617 A study to find new treatments for patients with blood cancers Not Yet Recruiting Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs Intervention1: Phase-1: Cohort-1
Inj Azacytidine
Inj Artesunate: Inj Azacytidine x 75mg/m2 per day for 7 days
Inj Artesunate x 2.4mg/kg per day x 7 days
the above will be repeated for every 28 days for 4 cycles
Intervention2: Phase-1: Cohort-2:
Inj Azacytidine
Inj. Artesunate
Inj. Arsenic trioxide: Inj Azacytidine 75mg/m2 per day for 7days
Inj. Artesunate 2.4mg/kg per day for 7 days
Inj. Arsenic trioxide 10mg per day for 14 days.
The above will be repeated every 28 days for 4 cycles.
Intervention3: Phase-1: Cohort-3:
Inj Azacytidine
Inj Artesunate
Inj Arsenic trioxide: Inj Azacytidine 75mg/m2 per day for 7days
Inj. Artesunate 4mg/kg per day for 14 days
Inj. Arsenic trioxide 10mg per day for 14 days.
The above will be repeated every 28 days for 4 cycles.
Intervention4: Recommended dose and schedule informed from Phase I study: Recommended dose and schedule informed from Phase I study
Control Intervention1: For Phase 2
Inj Azacytidine
Tab Venetoclax: Inj Azacytidine 75mg/m2 per day for 7 days
Tab Venetoclax 100mg per day for 14 days
Best response rate (CR+iCR+MLFS) at end of 4 cycles of treatmentTimepoint: At 30 days
At 60 days
At 180 days and
Once in a year India Alliance DBT Wellcome - - 183 India Alliance DBT Wellcome Interventional Study Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 18/03/2024 05/03/2024 04/01/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=99587 Localised/Locoregional Company Y Y N India Leukemia Acute Myeloid Leukemia, Adult Artesunate Response rate Phase 1/2 DB09274 N
CTRI/2024/03/063519 Effect of different modes of anaesthesia, i.e., TIVA using propofol and lignocaine with inhalational agents, on values of VEGF and Tells activity ( T helper cell CD4+ and cytotoxic T cells CD 8 +). Not Yet Recruiting Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Intervention1: TIVA (total intravenous
anaesthesia)
: BIS guided propofol infusion and lignocaine at the dose of 1.5 mg/kg/hr will be used for
anaesthesia maintenance. lignocaine infusion will be stopped at the starting of skin closure.
Control Intervention1: Inhalational anaesthesia: inhalation anaesthetic agent for
anaesthesia maintenance,as per standard anaesthesia practice.
To compare difference in change of post-operative and preoperative VEGF (Day 2 -preoperative) in both the groups.Timepoint: day 2 All India Institute Of Medical Sciences Jodhpur - - 38 All India Institute Of Medical Sciences Jodhpur 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:Open Label AIIMS/IEC/2023/4712 15/03/2024 04/03/2024 04/01/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=96584 Localised/Locoregional Collaborative Group Y N N India Gynaecological Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Ovarian - Other; Fallopian Tube Cancer Propofol Biomarker Phase 4 DB00818 N
ChiCTR2400082666 A single-arm, multicenter prospective study of RAS inhibitors combined with bevacizumab in patients with mCRC Recruiting colorectal cancer Treatment group:losartan+Bevacizumab + chemotherapy (CapeOx+mXELIRI); ORR(Objective response rate); Jiangjin Central Hospital of Chongqing All 18 - 75 Treatment group:92; Scientific research fund Interventional Study Single arm 28/08/2023 04/03/2024 04/08/2024 https://www.chictr.org.cn/showproj.html?proj=210929 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N China GI Rectal Cancer; Colon Cancer Losartan Response rate Phase 2 DB00455 N
ChiCTR2100053586 Effects of different anesthesia methods on postoperative recovery and prognosis of patients with colorectal tumors Pending colorectal cancer Group 1:Intravenous anesthesia;Group 2:Intravenous anesthesia + lidocaine;Group 3:Ihalation anesthesia;Group 4:Inhalation anesthesia + lidocaine; Plasma NETosis-specific markers (MPO and H3Cit);Tumor progression and metastasis related markers (VEGF-A, MMP-3, MMP-9); Shanghai Changhai Hospital All 18 - 70 Group 1:30;Group 2:30;Group 3:30;Group 4:30; Shanghai Youth Science and Technology Rising Star Program (19QA1408500) Interventional Study Parallel 01/05/2022 24/11/2021 15/04/2024 https://www.chictr.org.cn/showproj.html?proj=127392 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Lidocaine Biomarker Phase 4 DB00130 N
CTRI/2024/04/065574 Study to compare the longevity of life between using low-dose immunotherapy before surgery and only surgery alone for advanced stage oral cancer Not Yet Recruiting Health Condition 1: O- Medical and Surgical Intervention1: Neoadjuvant systemic therapy: Arm B (Experimental Arm)
Patients in Arm B will receive metronomic chemotherapy (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) with low-dose nivolumab (Nivolumab- Inj Nivolumab 40 mg in 100 ml NS over 60 minutes every 3 weekly.) Patients post completion of 2 cycles will be seen in a joint clinic for assessment of surgery. Response assessment will be done using clinical and imaging (CT, MRI, CTPET) at 2-4 weeks after the completion of 2nd cycle. All patients responding to treatment or without progressive disease will receive 3rd cycle of therapy if clinically indicated. The maximum permissible time between day 1 (or day 21) of last NACT cycle and surgery will be 4 weeks. The postoperative radiation will be similar to that in Arm A. Concurrent chemotherapy will be used in case of margin positive status or extra nodal extension or 2 lymph nodes are positive. Cisplatin 100 mg/m2 3-weekly or cisplatin 40 mg/m2 weekly or docetaxel 15 mg/m2 or any other NCCN recommended regimen will be the preferred agents. All dose adjustments will be made as per the standard management guidelines. The follow-up post-treatment will be as per institutional protocol.
Control Intervention1: Upfront surgery: Arm A (Standard arm)
Patients in arm A would be planned for upfront surgery followed by adjuvant RT or CTRT.
The surgery would be done in accordance with institutional standards. In short, the guidance for doing surgery is given below, however, these can be modified as per the patients need and treating surgeons judgment.
Primary
Local tumor excision
The aim of surgery would be to achieve R0 resection.
The surgery done for primary would be wide loca To compare the disease-free survival between the 2 armsTimepoint: 3 years Tata Memorial Centre - - 348 Intra and Extramural grant, Tata Memorial Centre, Mumbai Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label 22/04/2024 12/04/2024 29/04/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=103698 Palliative Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Any head and neck squamous cell carcinoma Celecoxib DFS/RFS/EFS Phase 3 DB00482 N
CTRI/2024/04/065470 Effect of addition of aspirin in cervical cancer survival Not Yet Recruiting Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Intervention1: Drug: Aspirin 150 mg PO daily along with the standard of care
Control Intervention1: Standard of Care: Standard of care as per the stage of the disease and guidelines ie Surgery, Chemotherapy followed by surgery, Concurrent chemoradiotherapy, surgery followed by radiotherapy or CCRT or palliative chemotherapy as per the investigators choice.
(a)Progression Free Survival
(b)Disease Free Survival
Timepoint: 1 year Department of Surgical Oncology - - 60 Department of Surgical OncologyInstitute of Medical Sciences, Banaras Hindu University, Varanasi-221005, UP, India Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant Blinded 20/04/2024 09/04/2024 29/04/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=102146 Any/All Stages Hospital/University/Research Institute Y N N India Gynaecological Cervical Cancer Acetylsalicylic Acid DFS/RFS/EFS Phase 2 DB00945 N
IRCT20230627058596N1 Effect of Atorvastatin Usage on Patients with Oral squamous cell carcinoma Recruiting Oral squamous cell carcinoma.
Malignant neoplasm of mouth, unspecified;C06.9 Intervention 1: Intervention group: Surgery and Atorvastatin, 40 mg pill, C33H35FN2O5, daily, for 1 month, swallowing with water. Intervention 2: Control group: Surgery. Superoxide dismutase marker in the saliva. Timepoint: At the beginning of the study and 1 month after taking the drug. Method of measurement: The variable measurement (Superoxide Dismutase marker) in saliva is performed by qRT-PCR method in the laboratory.;Angiogenesis Factors in the Saliva. Timepoint: At the beginning of the study and 1 month after taking the drug. Method of measurement: The measurement of variables (Angiogenesis Factors) in saliva is carried out using the qRT-PCR method in the laboratory.;Beta-2 microglobulin Factor in the saliva. Timepoint: At the beginning of the study and 1 month after taking the drug. Method of measurement: The measurement of variables (Beta-2 microglobulin Factor) in saliva is carried out using the qRT-PCR 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 22/07/2024 https://irct.behdasht.gov.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 DB01076 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, Part A: To investigate the safety and tolerability of AZD9291 when given in combination with AZD6094 or selumetinib who have progressed following prior therapy with an EGFR TKI agent, and define the combination dose(s) for further clinical evaluation., Adverse events will be collected from baseline until 28 days after the last dose in the AZD6094 or selumetinib arms.; Number of participants with Adverse Events as a measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib, Part B: To investigate the safety and tolerability of AZD9291 when given in combination with AZD6094 or selumetinib in patients with locally advanced or metastatic NSCLC, who have progressed on prior therapy with an EGFR TKI agent.Part C monotherapy cohort (Japan only): To investigate and confirm the safety and tolerability of AZD6094 when given orally to Japanese patients with advanced solid malignancies.Part C combination cohort (Japan only): To investigate the safety and tolerability of AZD9291 when given orally to Japanese patients with EGFRm+ NSCLC in combination with AZD6094 who have progressed following prior therapy with an EGFR TKI agent, and define the combination dose(s) for further clinical evaluation.Part D: To investigate the safety and tolerability of AZD9291 when given in combination with AZD6094 (300 mg OD) in patients with locally advanced or metastatic EGFRm+ NSCLC., Adverse events: baseline until 28 days after the last dose in the AZD6094 or selumetinib arms. AstraZeneca All ADULT, OLDER_ADULT 344 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT D5160C00006; 2016-004752-29 08/05/2014 03/04/2020 31/12/2024 21/05/2014 09/03/2024 https://clinicaltrials.gov/study/NCT02143466 Advanced/Metastatic; Recurrent/Refractory Company N Y N United States Lung Non-Small Cell Lung Cancer Selumetinib Safety and/or Dose Phase 1 DB11689 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, Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, 12 Months; Safety and Tolerability of Durvalumab with Selumetinib and BI, Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, 6 month; Determine the Clinical Benefit of Selumetinib, BI and Durvalumab, Clinical benefit rate defined as radiographic complete response, partial response, or stable disease, greater than or equal to four cycles, 24 Months University of Alabama at Birmingham All ADULT, OLDER_ADULT 41 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 300006373 15/12/2024 15/12/2029 15/12/2030 23/02/2022 14/06/2024 https://clinicaltrials.gov/study/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 DB11689 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, MTD defined by dose limiting toxicities (DLTs) that occur during the first 4 weeks of therapy and are related to the study medications. Grading of DLTs follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03., 28 days M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 90 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2016-1129; NCI-2018-01205 08/04/2017 30/08/2026 30/08/2026 22/05/2017 16/10/2024 https://clinicaltrials.gov/study/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 DB11689 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, A responder is defined as a patient who achieves a best response of partial response (PR) or complete response (CR) on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors., From enrollment to the end of treatment, up to 2 years National Cancer Institute (NCI) All CHILD, ADULT 21 NIH Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCI-2017-01250; NCI-2017-01250; APEC1621E; APEC1621E; APEC1621E; U10CA180886 30/10/2017 30/06/2021 22/09/2025 07/11/2017 13/12/2022 23/10/2024 https://clinicaltrials.gov/study/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 DB11689 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 RECRUITING 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), The MTD is empirically defined as the highest dose level at which 6 patients have been treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic., 1 month post enrollment; Event-free survival (efficacy), Will use Kaplan-Meier (KM) methods and stratified log-rank tests to estimate EFS per arm and compare the EFS outcome between the two arms to assess difference in efficacy. EFS is defined as the interval from randomization to the first occurrence of clinical or radiographic disease progression, disease recurrence, subsequent malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up., Up to 5 years after enrollment National Cancer Institute (NCI) All CHILD, ADULT 300 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT NCI-2020-07549; NCI-2020-07549; ACNS1931; ACNS1931; U10CA180886 16/02/2021 30/12/2026 30/12/2026 10/06/2020 15/11/2024 https://clinicaltrials.gov/study/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 DB11689 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), Using the efficacy analysis set, the estimate of ORR will be measured independently for each treatment arm and reported with 95 exact confidence interval. Participants who, within their respective treatment arm, achieve a complete response (CR) or a partial response (PR) that is confirmed on a second scan at least 4 weeks later on the current protocol will be qualified as achieving a response, and will count towards the ORR measurement., End of treatment (Up to 24 months) OHSU Knight Cancer Institute All ADULT, OLDER_ADULT 132 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00018504; NCI-2019-00388; STUDY00018504 12/12/2018 31/12/2025 31/12/2027 01/11/2019 13/08/2024 https://clinicaltrials.gov/study/NCT03801369 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Breast Breast Cancer - TNBC Selumetinib Response rate Phase 2 DB11689 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, To determine the maximum tolerated dose (MTD) of selumetinib when combined with azacitidine and measure any toxicities that may arise., Up to 24 months. University of Chicago All ADULT, OLDER_ADULT 18 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRB17-0774 09/04/2018 09/04/2025 09/04/2025 31/10/2017 29/01/2024 https://clinicaltrials.gov/study/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 DB11689 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), The percentage of patients with a confirmed investigator-assessed complete or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1. Patients will be followed up every 6 weeks ( 1 week) for the first 24 weeks and every 9 weeks thereafter until RECIST 1.1 defined disease progression or cessation of study treatment (if treating beyond progression)., Measured from first dose until confirmed response or progression. For each patient this is expected to be 3 months on average AstraZeneca All ADULT, OLDER_ADULT 248 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT D6186C00001; 2018-003974-29 25/06/2019 05/06/2025 05/06/2025 05/10/2019 17/07/2024 https://clinicaltrials.gov/study/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 DB11689 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, RECIST1.1 measurements of CT scans will be measured during treatment to determine the objective response rate for patients being treated with combination osimertinib and selumetinib. A response rate and a 95 confidence interval will be calculated., 2 years Dana-Farber Cancer Institute All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 17-540 31/01/2018 30/06/2025 30/06/2026 01/05/2018 08/06/2024 https://clinicaltrials.gov/study/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 DB11689 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), Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0., 28 days; Stratum-specific objective response (complete response + partial response) rate sustained for 8 weeks (phase II), For each stratum separately exact confidence interval estimates will be provided for the true, unknown rates of objective response. In addition, the confirmed sustained objective response rate observed during treatment by cumulative incidence functions will be estimated. This provides not only an overall estimate of the response rate but also an estimate of the timing of responses as a function of number of months of treatment., 40 weeks; Objective response (objective response = complete response + partial response) (re-treatment study), Exact confidence interval estimates will be provided., Up to 48 weeks; Disease stabilization rates (re-treatment study), Disease stabilization rates will be measured., At 1 year National Cancer Institute (NCI) All CHILD, ADULT 220 NIH Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCI-2012-03173; NCI-2012-03173; PBTC-029B; CDR667932; PBTC-029; PBTC-029; U01CA081457; UM1CA081457 19/04/2010 12/01/2025 12/01/2025 18/03/2010 23/10/2024 https://clinicaltrials.gov/study/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 DB11689 N
NCT00463814 AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies ACTIVE_NOT_RECRUITING Tumor|Cancer DRUG: AZD6244 Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Part A and Part B, An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug., Day 1 through 11.8 months (maximum observed duration); Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Part A and Part B, Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis., Day 1 through 11.8 months (maximum observed duration); Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A and Part B, Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, oxygen saturation, weight, and pulse rate)., Day 1 through 11.8 months (maximum observed duration); Number of Participants With Abnormal Echocardiogram (ECHO) Parameters Reported as TEAEs in Part A and Part B, Number of participants with abnormal ECHO parameters reported as TEAEs are reported., Day 1 through 11.8 months (maximum observed duration); Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Part A and Part B, Number of participants with abnormal ECG parameters reported as TEAEs are reported., Day 1 through 11.8 months (maximum observed duration) AstraZeneca All ADULT, OLDER_ADULT 58 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT D1532C00005; 2022-500685-10-00; 2006-004497-26 03/08/2007 17/06/2008 31/12/2024 20/04/2007 22/11/2024 https://clinicaltrials.gov/study/NCT00463814 Advanced/Metastatic Company N N N United Kingdom Multiple cancer types Any solid tumours Selumetinib Safety and/or Dose Phase 1 DB11689 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, To evaluate whether treatment with targeted agents guided by high throughput molecular analysis (CGH array, next generation sequencing) improves progression-free survival as compared to standard maintenance therapy in patients with metastatic Breast Cancer, from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months) UNICANCER All ADULT, OLDER_ADULT 1460 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT02299999 Advanced/Metastatic Hospital/University/Research Institute Y Y N France Breast Any Breast Cancer Selumetinib Response rate; PFS; OS Phase 2 DB11689 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), Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression), Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI) AstraZeneca All ADULT, OLDER_ADULT 510 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT D1532C00079; 2013-001676-38 25/09/2013 06/07/2016 31/12/2024 09/02/2013 29/08/2017 25/11/2024 https://clinicaltrials.gov/study/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 DB11689 N
NCT02450656 Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer M14AFS UNKNOWN Colorectal Neoplasms|Gastrointestinal Neoplasms|Pancreatic Neoplasms|Carcinoma, Non-Small-Cell Lung DRUG: Afatinib; DRUG: Selumetinib; DRUG: Docetaxel Dose Limiting Toxicities (Phase I), Incidence of DLTs in the first treatment cycle, Cycle 1 (4 weeks); Progression Free Survival (Phase II), PFS measured by RECIST v 1.1, CT scan every 6 weeks and monthly phone call until start of subsequent anticancer therapy or until all patients have been followed up for at least 18 months of have been lost to follow up, whichever occurs first The Netherlands Cancer Institute All ADULT, OLDER_ADULT 320 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT M14AFS 06/01/2015 05/01/2019 12/01/2019 21/05/2015 27/08/2018 https://clinicaltrials.gov/study/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 DB11689 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, Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 10 weeks post initiation of therapy University Health Network, Toronto All ADULT, OLDER_ADULT 57 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT BIL-MEK 11/01/2014 12/01/2024 12/01/2025 30/05/2014 24/01/2024 https://clinicaltrials.gov/study/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 DB11689 N
NCT03581487 Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer ACTIVE_NOT_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), The standard 3+3 design will be applied to determine the MTD among the three pre-defined dose levels., Up to 2 years; Progression free survival time (PFS) (dose expansion phase), The estimated PFS will be provided with 95 confidence interval. Will be estimated using the Kaplan-Meier method and the comparison between or among patient's characteristic groups will be evaluated by log-rank test. The Cox regression model may be applied to assess the effect of covariates of interest on PFS., From start of treatment assessed up to 2 years M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2017-0888; NCI-2018-01098; 2017-0888 04/01/2019 31/12/2025 31/12/2025 07/10/2018 20/11/2024 https://clinicaltrials.gov/study/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 DB11689 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), The Kaplan-Meier method will be used to estimate EFS which is defined as the interval from randomization to first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, or to the date of last follow-up. Estimates with 95 confidence intervals will be reported by treatment arm. The hazard ratio with a confidence interval will also be reported to compare treatment arms based on a Cox proportional hazards model stratified by BRAF status, tumor location and size of residual tumor., Up to 10 years from date of randomization National Cancer Institute (NCI) All CHILD, ADULT 220 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NCI-2019-07600; NCI-2019-07600; ACNS1833; ACNS1833; U10CA180886 31/01/2020 31/12/2026 31/12/2026 18/11/2019 19/11/2024 https://clinicaltrials.gov/study/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 DB11689 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., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of AZD4547 monotherapy given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module A: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral AZD4547., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with AZD4547 given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module B: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and oral olaparib., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with olaparib given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module C: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral AZD1775., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) given intravenously in combination with AZD1775 given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module D: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) monotherapy., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI4736 (durvalumab) monotherapy given intravenously to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module E: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral vistusertib., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI 4736 (durvalumab) given intravenously in combination with vistusertib given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module F: The frequency and nature of adverse events related to the combination of intravenous MEDI4736 (durvalumab) and intravenous AZD9150., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of intravenous MEDI4736 (durvalumab) in combination with intravenous AZD9150 in selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; Module G: The frequency and nature of adverse events related to intravenous MEDI4736 (durvalumab) when given in combination with oral selumetinib., The frequency and nature of adverse events will be assessed in order to determine the safety and tolerability of MEDI 4736 (durvalumab) given intravenously in combination with selumetinib given orally to selected patients with MIBC who have progressed following prior therapy., Adverse events will be assessed at each clinic visit, and at study discontinuation and 90 days after the end of treatment. Clinic visits are generally scheduled weekly.; All Modules: Change from baseline in clinical chemistry parameters., Changes from baseline in clinical chemistry parameters will be assessed in order to determine the safety and tolerability of the drug regimen chosen in the sub study module for patients with MIBC who have progressed following prior therapy., Days 1, 8, 15, and 22 of Cycle 1, Days 1, 15, and 22 of Cycles 2 and 3 and every 4 weeks thereafter, and at discontinuation.; All Modules: Change from baseline in haematology AstraZeneca All ADULT, OLDER_ADULT 156 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT D2615C00001; GU 118; BISCAY; 2015-002228-25 10/03/2016 18/03/2020 28/06/2024 09/11/2015 03/12/2024 https://clinicaltrials.gov/study/NCT02546661 Advanced/Metastatic Company N Y N United States Urological Bladder Cancer Selumetinib Safety and/or Dose Phase 1 DB11689 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), Disease progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria, as determined by the treating physician. The primary analyses will be based on logrank tests stratified by the stratification factors as recorded at randomization. All enrolled patients will be included, regardless of compliance with their assigned study regimen. Patients will be grouped by their randomized treatment for intention-to-treat analyses. Treatment hazard ratios and 90 confidence intervals will be estimated using proportional hazards models specified with a main-effect for the randomized treatment assignment (experimental versus \[vs\] reference), and stratified using the stratification factors recorded at randomization. Treatment group differences will be graphed using Kaplan-Meier methods., The duration of time from enrollment to the date of progression or death, whichever occurs first, assessed up to 5 years National Cancer Institute (NCI) Female ADULT, OLDER_ADULT 165 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NCI-2022-06841; NCI-2022-06841; EAY191-N4; EAY191-N4; U10CA180868 25/04/2023 10/01/2028 10/01/2028 26/09/2022 25/11/2024 https://clinicaltrials.gov/study/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 DB11689 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), PFS rate at 4 months is defined by the number of patients alive at 4 months from inclusion without PD divided by the total number of patients evaluable at 4 months (dead during 4 months or alive at 4 months with a progressive status available)., at 4 months; ARM B/ C - PFS, PFS is defined as time from randomization into arm B/C to the date of first documented PD RECIST 1.1 and/or iRECIST for arm B and PD RECIST1.1 for arm C or death., Assessed up to 36 months GERCOR - Multidisciplinary Oncology Cooperative Group All ADULT, OLDER_ADULT 307 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|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/study/NCT04348045 Advanced/Metastatic Collaborative Group Y Y N France GI Pancreatic Cancer Selumetinib Safety and/or Dose; Response rate; PFS; OS Phase 2 DB11689 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, Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations)., Up to 8 years; Assignment of patients to ComboMATCH treatment trials, Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations)., Up to 8 years; Enrollment rates to ComboMATCH treatment trials, Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations)., Up to 8 years National Cancer Institute (NCI) All CHILD, ADULT, OLDER_ADULT 2900 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING NCI-2022-06842; NCI-2022-06842; EAY191; EAY191; U10CA180820 04/07/2023 07/01/2030 07/01/2030 10/03/2022 21/11/2024 https://clinicaltrials.gov/study/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 DB11689 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), MTD will be defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). Graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)., 28 days National Cancer Institute (NCI) All ADULT, OLDER_ADULT 19 NIH Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCI-2012-02906; NCI-2012-02906; CDR0000700596; MC1012; NCI-2011-01083; 8810; 8810; P30CA015083; U01CA069912; UM1CA186686 25/05/2011 06/06/2019 03/07/2025 06/02/2011 19/09/2024 https://clinicaltrials.gov/study/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 DB11689 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, Number of men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy that have greater intra-prostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group.Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis., 8 weeks Medical University of South Carolina Male ADULT, OLDER_ADULT 36 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 103472 03/11/2024 28/02/2026 08/01/2026 19/10/2022 24/04/2024 https://clinicaltrials.gov/study/NCT05586360 Localised/Locoregional Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Simvastatin Other (specify) Phase 2 DB00641 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, Percentage of patients who complete the simvastatin intervention with at least 85 compliance during Carboplatin and Doxil chemotherapy., From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days) Bobbie Jo Rimel, MD Female ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT2020-03-Rimel-STOV 25/01/2021 01/01/2025 01/01/2026 07/07/2020 08/02/2024 https://clinicaltrials.gov/study/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 DB00641 N
NCT04698941 Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy UNKNOWN Small Cell Lung Cancer DRUG: Albumin Paclitaxel; DRUG: Simvastatin Disease control rate (DCR), To assess disease control rate (DCR) after treatment., 6 weeks Shanghai Pulmonary Hospital, Shanghai, China All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2020LY021 25/07/2021 30/12/2021 30/12/2022 01/07/2021 29/07/2021 https://clinicaltrials.gov/study/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 DB00641 N
NCT01441349 Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer UNKNOWN Small Cell Lung Carcinoma DRUG: IP chemotherapy; DRUG: IP chemotherapy plus simvastatin 1-year survival rate, Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen ) Follow - up visits are conducted every 8 weeks to obtain meaningful data on time- to event variables. Assessment will continue until death or 12 months after treatment., every 8 weeks National Cancer Center, Korea All ADULT, OLDER_ADULT 192 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NCCCTS-11-527 08/01/2011 31/10/2022 31/12/2022 27/09/2011 04/06/2022 https://clinicaltrials.gov/study/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 DB00641 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, Negative change denotes reduction. Ki-67 is a validated surrogate marker for disease-free survival in patients with hormone receptor positive (HR+), HER2- breast cancer. Ki-67 values at 14 days are expressed as geometric mean proportions of the baseline and transformed into percentage change. Geometric mean percentage change of Ki-67 from pre- to post-treatment is calculated and compared between the two treatment arms. A two-sided Mann-Whitney U or Wilcoxon Rank-Sum test is used., From pre-surgical baseline to 14 days following preoperative therapy Emory University Female ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT STUDY00004257; NCI-2022-02545; STUDY00004257; WINSHIP5524-22; P30CA138292 09/02/2022 15/04/2025 15/04/2025 19/07/2022 12/05/2023 https://clinicaltrials.gov/study/NCT05464810 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Breast Cancer - ER/HR+ Simvastatin Biomarker Phase 1 DB00641 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, Vimentin expression is measured based on Histoscore (H-Score) with immunohistochemistry examination:* 0-50 : negative (0)* 51-100 : weak positive (1+)* 101-200 : moderate positive (2+)* 201-300 : strong positive (3+), 6 months Indonesia University Female ADULT, OLDER_ADULT 26 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT IndonesiaU2022 19/08/2022 05/01/2025 08/01/2025 22/09/2022 10/03/2024 https://clinicaltrials.gov/study/NCT05550415 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute Y N N Indonesia Breast Breast Cancer - TNBC Simvastatin Biomarker Phase 2 DB00641 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), PFS is defined as the time from randomization to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first. PFS will be censored at the time of the last available tumor assessment documenting absence of progressive disease for patients alive at the time of analysis., 40 months National Cancer Institute, Naples All ADULT, OLDER_ADULT 240 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT VESPA; 1/23 06/12/2023 08/01/2025 06/01/2026 20/04/2023 18/06/2024 https://clinicaltrials.gov/study/NCT05821556 Advanced/Metastatic Hospital/University/Research Institute Y N N Italy GI Pancreatic Cancer Simvastatin; Valproic Acid PFS Phase 2 DB00641; DB00177 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; DRUG: Naxitamab Proportion of patients who have objective response in the tumor, Objective response = complete response + partial response + minor response + stable disease, 1-2 months Hong Kong Children's Hospital All CHILD, ADULT 29 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT HKCH-REC-2021-007 01/01/2022 31/12/2024 31/12/2025 03/06/2023 10/03/2024 https://clinicaltrials.gov/study/NCT05754684 Recurrent/Refractory Hospital/University/Research Institute N N N Hong Kong Other Neuroblastoma Spironolactone Response rate Phase 2 DB00421 N
NCT06134388 Sulfasalazine in Patients With Metastatic Colorectal Cancer RECRUITING Metastatic Colorectal Cancer DRUG: Sulfasalazine Evaluating the change in the serum level of Ferritin, 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 Bcl-2 associated X protein (Bax), Blood samples will be collected at baseline and 3 months after treatment., 3 months; Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR)., Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. ORR will be determined as number and percentage., 3 months; Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR)., Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. DCR will be evaluated and categorized according to the RECIST 1.1 criteria. DCR includes patients with complete response, partial response and stable disease. DCR will be determined as number and percentage., 3 months Tanta University All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT Sulfasalazine 2023 09/01/2023 09/01/2025 09/01/2026 18/11/2023 18/11/2023 https://clinicaltrials.gov/study/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
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), Rate of dose limiting toxicity at least possibly attributable to study treatment, 2 years; Overall Survival (OS), Overall survival at 12 months post-enrollment, 12 months University of California, San Diego All ADULT, OLDER_ADULT 7 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 190098 04/07/2020 03/01/2026 03/01/2029 20/06/2019 18/11/2024 https://clinicaltrials.gov/study/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
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), Up to approximately 12 months (Arms A and B) or 24 months (Arm C) Hoffmann-La Roche All ADULT, OLDER_ADULT 137 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT BO43243 03/07/2022 27/05/2027 10/08/2029 25/10/2021 31/10/2024 https://clinicaltrials.gov/study/NCT05091424 Recurrent/Refractory Company N N N Spain Leukemia Chronic Lymphocytic Leukemia Tocilizumab Safety and/or Dose Phase 1 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, Intratumoral CD3+ T-cells will be identified by immunohistochemistry in pre- and post-treatment tumor specimens. The analysis population for the primary outcome will be all patients who received at least 2 weeks of neoadjuvant therapy with pre- and post-treatment tumor specimens that are evaluable for CD3+ T-cells. The proportion of patients with a \>= 40 increase (from pre- to post-treatment) will be calculated. The exact 95 confidence intervals (CIs) using the Pearson-Clopper method and an exact binomial test will be used as an exploratory purpose. The change from pre-treatment to post-treatment CD3 count per mm\^3 as a continuous measure will also be summarized., Up to 2 years; R0 resection rate, Patients who undergo surgery will be evaluable for R0 resection rate. R0 resection rate will be described by point estimate and 95 CI using the Pearson-Clopper method., Up to 2 years Alain Algazi All ADULT, OLDER_ADULT 55 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|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/study/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
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, through study completion (i.e. up to 2 years); Efficacy of tocilizumab in Black and non-Black patients, efficacy defined as using the difference in difference approach across race based cohorts, through study completion (i.e. up to 2 years); Progression-free survival, through study completion (i.e. up to 2 years) Kathy Miller All ADULT, OLDER_ADULT 168 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT CTO-IUSCCC-0817 07/02/2024 12/01/2026 12/01/2026 05/06/2023 19/09/2024 https://clinicaltrials.gov/study/NCT05846789 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Breast Cancer - TNBC Tocilizumab Response rate Phase 2 DB08895 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), Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks., From first dose of protocol treatment until radiologic disease assessment at 12 weeks. Abramson Cancer Center at Penn Medicine All ADULT, OLDER_ADULT 28 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT UPCC 16520 25/07/2023 12/01/2025 09/01/2026 31/12/2020 18/10/2024 https://clinicaltrials.gov/study/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
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, A positive response is defined as a 40 increase in the number of infiltrating cluster of differentiation 3 (CD3) + T cells between the pre-treatment biopsy at baseline and the post-treatment RP specimen. Thus, a negative response is a \<40 increase. The primary endpoint will include all enrolled subjects who receive at least 1 dose of study treatment and undergo RP. Analysis of the primary endpoint will be performed for each cohort independently, Up to 12 months David Oh Male ADULT, OLDER_ADULT 68 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 18702; NCI-2018-02805 30/10/2019 28/02/2025 28/02/2025 29/01/2019 08/02/2024 https://clinicaltrials.gov/study/NCT03821246 Localised/Locoregional Company N Y N United States Urological Prostate Cancer Tocilizumab Safety and/or Dose; Response rate; Biomarker Phase 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 Percentage of Participants With Grades 3-5 Treatment Related Immune Related Adverse Events (irAEs), Adverse events are graded according to the NCI CTCAE version 5.0. Immune-related adverse events (irAEs) are specific events occurring within 100 days of the last dose (which includes pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine abnormalities \[adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis\]), regardless of causality, for which patients received immunosuppressive medication for treatment of the event. The exception to the immunosuppressive medication criteria for irAEs is endocrine events (e.g., hypothyroidism/thyroiditis, hyperthyroidism, hypophysitis, diabetes mellitus, adrenal insufficiency), which are included regardless of treatment since these events are often managed without immunosuppression., From start of treatment up to 100 days post treatment, *up to 18 months*; Objective Response Rate (ORR), Objective Response Rate (ORR) is defined as the total number of patients whose best response outcome is a CR or PR by week 24 divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30 decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., Week 24 NYU Langone Health All ADULT, OLDER_ADULT 71 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 19-00008 06/11/2019 07/01/2023 19/01/2025 27/06/2019 10/09/2024 10/09/2024 https://clinicaltrials.gov/study/NCT03999749 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Tocilizumab Other (specify) 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), The MTD for each arm is selected based on isotonic regression27, using the shiny app BOINComb (http://www.trialdesign.org). The dose is selected as the MTD for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate; the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate., Completion of cycle 1 (each cycle is 21 days) Emory University All ADULT, OLDER_ADULT 72 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY00002448; NCI-2021-02510; STUDY00002448; WINSHIP5273-21; P30CA138292 19/10/2022 02/12/2026 02/12/2027 26/05/2022 28/02/2024 https://clinicaltrials.gov/study/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
NCT03869190 Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) ACTIVE_NOT_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, Objective response rate, defined as the proportion of participants with a CR or PR on two consecutive occasions \>=4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1., Baseline until disease progression or loss of clinical benefit (approximately 5-7 years); pCR for Muscle Invasive Bladder Cancer (MIBC) Cohorts, pCR, defined as the proportion of participants with an absence of residual invasive cancer of the complete resected specimen., Randomization to approximately 5-7 years Hoffmann-La Roche All ADULT, OLDER_ADULT 645 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT WO39613 06/01/2019 30/10/2024 21/05/2026 03/11/2019 24/09/2024 https://clinicaltrials.gov/study/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
NCT05207670 A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies MorningSun ACTIVE_NOT_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), From the first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by the investigator according to Lugano Criteria 2014 (minimum 2 years); 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), Cycles 4, 8, 12 and 17 (cycle length=21 days) Genentech, Inc. All ADULT, OLDER_ADULT 345 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT ML43389 02/01/2022 31/07/2028 31/07/2028 26/01/2022 19/09/2024 https://clinicaltrials.gov/study/NCT05207670 Any/All Stages Company N N N United States Lymphoma Follicular Lymphoma; Lymphoma - Other Tocilizumab Response rate; PFS; OS Phase 2 DB08895 N
NCT04729959 Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma ACTIVE_NOT_RECRUITING 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), Will be assessed by Common Terminology Criteria for Adverse Events version 5.0., Up to 1 post-fractionated stereotactic radiation therapy (FRST) cycle of systemic therapy for which dose-limiting toxicity is reached (1 cycle = 4 weeks); Maximum-tolerated dose (Safety Run-In), Up to 1 post-FRST cycle of systemic therapy for which dose-limiting toxicity is reached (1 cycle = 4 weeks); Objective radiographic response rate (Phase II, Non-Surgical Cohort), Will be determined using modified Response Assessment in Neuro-oncology with the pretreatment magnetic resonance imaging as baseline. Frequencies and percent of responses will be provided for patients with measurable disease., Up to 6 months from enrollment National Cancer Institute (NCI) All ADULT, OLDER_ADULT 53 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NCI-2021-00410; NCI-2021-00410; NRG-BN010; NRG-BN010; U10CA180868 03/11/2022 06/01/2025 06/01/2025 29/01/2021 18/11/2024 https://clinicaltrials.gov/study/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
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, Will be summarized overall and for each tumor type using frequencies and percentages., Up to 2 years; Occurrence of one or more grade 3 or higher adverse event in a given patient (Cohort 1), Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Grade 3 or greater toxicity rate will be computed along with their associated exact 95 confidence interval., Up to 2 years M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 35 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2020-1166; NCI-2021-04325; 2020-1166 23/09/2021 31/12/2025 31/12/2025 25/06/2021 19/09/2024 https://clinicaltrials.gov/study/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
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), From randomization until disease progression or loss of clinical benefit (up to approximately 7-9 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 7-9 years) Hoffmann-La Roche All ADULT, OLDER_ADULT 340 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT WO39608; 2016-004126-42 07/05/2017 31/01/2025 31/01/2025 20/06/2017 11/08/2024 https://clinicaltrials.gov/study/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
NCT04524871 A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) MORPHEUS-LIVER RECRUITING Advanced Liver Cancers DRUG: Atezolizumab; DRUG: Bevacizumab 15 mg/kg; DRUG: Tiragolumab; DRUG: Tocilizumab; DRUG: TPST-1120; DRUG: Tobemstomig 2100 mg; DRUG: Bevacizumab 10 mg/kg; DRUG: Tobemstomig 600 mg; DRUG: Tobemstomig 1200 mg; DRUG: ADG126; DRUG: IO-108 1800 mg; DRUG: NKT2152; DRUG: IO-108 1200 mg Objective Response Rate (ORR), ORR, defined as the proportion of participants with a complete response or partial response on two consecutive occasions \>=4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1., From randomization until disease progression or loss of clinical benefit (up to approximately 7-9 years) Hoffmann-La Roche All ADULT, OLDER_ADULT 518 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT GO42216 11/02/2020 31/08/2026 31/08/2026 24/08/2020 13/11/2024 https://clinicaltrials.gov/study/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
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, The primary outcome is efficacy of tocilizumab in patients with high and low stroma activation defined as pathological response according to the Mandard criteria, 34 months Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) All ADULT, OLDER_ADULT 41 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NL74310.018.20; 2020-002909-25 27/01/2021 10/10/2022 04/10/2028 18/09/2020 29/07/2024 https://clinicaltrials.gov/study/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
NCT05595473 A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma ACTIVE_NOT_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, Day 1 to Day 28; 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, Day 1 to Day 15; 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, Day 1 to Day 15; 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, Day 1 to Day 15; 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, Day 1 to Day 15; Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE, Day 1 to Day 28 Rznomics, Inc. All ADULT, OLDER_ADULT 42 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT RZ-001 29/07/2022 03/01/2029 05/01/2029 27/10/2022 11/04/2024 https://clinicaltrials.gov/study/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
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, Median overall survival will be analyzed using Cox regression analysis and presented by Kaplan-Meier graphs. Proportion of patients alive at 12 or 24 months, respectively, in each study arm and will be analyzed using Fisher exact test., Study closure at 30 months follow up. Survival analyses will be analysed at 12 and 24 months.; Baseline and demographic data, All baseline and demographic data will be analysed using descriptive statistics such as mean, medians, standard deviations etc. for all variables which are continuous. Variables that are categorical will be analysed using frequency tables with number of patients and percent. All these analyses will be divided by treatment group. No formal hypothesis testing will be performed for the demographic and baseline variables., At 30 months follow up Cecilia Soderberg-Naucler All ADULT, OLDER_ADULT 220 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT Eudra CT: 2019-001083-30 09/04/2019 31/07/2027 31/07/2027 10/04/2019 26/10/2024 https://clinicaltrials.gov/study/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
NCT05166577 Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC ACTIVE_NOT_RECRUITING Nasopharyngeal Carcinoma|EBV-Related Gastric Carcinoma|EBV-Related Leiomyosarcoma|EBV Related Carcinoma|EBV-Related Sarcoma DRUG: Nanatinostat; DRUG: Nanatinostat; DRUG: Valganciclovir; DRUG: Pembrolizumab Phase 1b: Incidence of dose-limiting toxicities (DLTs), DLT period of 28 Days; Phase 2: Overall response rate (ORR), Approximately 3 years Viracta Therapeutics, Inc. All ADULT, OLDER_ADULT 26 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT VT3996-301 10/08/2021 30/10/2024 10/01/2025 22/12/2021 21/11/2024 https://clinicaltrials.gov/study/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
NCT04590664 Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma RECRUITING Glioblastoma|Recurrent Glioblastoma DRUG: Verteporfin Incidence of adverse events (Phase I), Will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For each adverse event, information to be collected includes event description, time of onset, clinician assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization of the event., From study enrollment until 100 days after the last day of study participation; Progression free survival (PFS) (Phase II), Will be assessed by Response Assessment in Neuro-Oncology Criteria (RANO) for magnetic resonance imaging (MRI) of glioblastoma. Progression-free survival is defined as no progression within 6 weeks. Progression-free survival will be estimated as a binary rate, and a 95 confidence interval will be estimated using the Clopper-Pearson method., At 6 weeks; Response rate (RR) (Phase II), Will be assessed by RANO for MRI of glioblastoma., From study enrollment until 2 years; Overall survival (Phase II), Will be estimated using the Kaplan-Meier method., Time from study enrollment to death or last follow-up, assessed up to 2 years Emory University All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY00000974; NCI-2020-05187; WINSHIP5070-20; P30CA138292 15/01/2021 15/08/2025 15/08/2025 19/10/2020 26/02/2024 https://clinicaltrials.gov/study/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
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., 24 months Baylor Research Institute All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 020-476 06/01/2021 06/01/2025 06/01/2026 15/06/2021 15/06/2021 https://clinicaltrials.gov/study/NCT04926467 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Anakinra PFS; OS; DFS/RFS/EFS Phase 2 DB00026 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, 2 years following study randomisation. St George's, University of London All ADULT, OLDER_ADULT 200 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB09274 N
NCT04862260 Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma ACTIVE_NOT_RECRUITING Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer|Pancreas Cancer|Metastatic Cancer DRUG: Cholesterol metabolism disruption Safety as measured by the rate of adverse events, To determine causality and grading severity of each adverse event (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., 2 years; Characterization of dose-limiting toxicities, To determine the dose at which no more than 1 out of 6 patients experience a drug related dose-limiting toxicity. To confirm that the combination of daily atorvastatin 40 mg, ezetimibe 10 mg twice daily and monthly evolocumab 420 mg meets the criterion to be the recommended phase II dose (RP2D)., 2 years CHU de Quebec-Universite Laval All ADULT, OLDER_ADULT 3 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CHLOE pancreas 10/04/2021 31/01/2025 31/12/2026 27/04/2021 22/05/2024 https://clinicaltrials.gov/study/NCT04862260 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Pancreatic Cancer Atorvastatin Safety and/or Dose; Biomarker Phase 1 DB01076 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, Radiological progression Radiological progression of the disease according to RECIST criteria (version 1.1.) compared to the situation at the start of cancer treatment in all cancer types. If the cancer treatment includes the use of immune checkpoint inhibitors, the imRECIST criteria are applied to evaluate the responseIn addition, the disease is considered advanced if both of the criteria below are met:* Biochemical progression: * PSA progression in prostate cancer, (three consecutive PSA increases measured at least one week apart, two \> 50 increases from the lowest PSA level and PSA \> 2 ng/ml) with testosterone at castration level (\< 50 ng/ml or 1.7 nmol/l) * Ca15-3 marker increase in breast cancer (three consecutive marker increases that the clinician considers significant) * In ovarian cancer, ca12-5 marker increase (three consecutive marker increases that the clinician considers significant)* Clinical progression o ECOG 3 or less (long-term), From randomization until the date of first documented progression, assessed at twelve week intervals up to 24 months; Mortality, Time to death from the beginning of the first-line medication, From randomization until the date of death, assessed up to 24 months Tampere University Hospital All ADULT, OLDER_ADULT 240 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2019-001982-34 31/03/2023 31/12/2025 31/12/2027 04/04/2023 16/05/2024 https://clinicaltrials.gov/study/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 DB01076 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, Invasive disease-free survival (IDFS), defined as the time from randomization until the date of the first occurrence of one of the following events:* Ipsilateral invasive breast tumor recurrence: invasive breast cancer involving the same breast parenchyma as the original primary.* Regional invasive breast cancer recurrence: Invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast.* Distant recurrence: Metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer.* Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause.* Contralateral invasive breast cancer.* Second primary non-breast invasive cancer., 10 years Aarhus University Hospital Female ADULT, OLDER_ADULT 3360 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04601116 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Denmark Breast Breast Cancer - ER/HR+ Atorvastatin DFS/RFS/EFS Phase 3 DB01076 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, antiproliferative effect Ki-67 molecular gene expression, 3 month; TAZ (WWTR1) TAZ expression, cell proliferative ability via TAZ (WWTR1) TAZ expression, 3 months; cardiac markers, protective effect of atorvastatin for Anthracycline induced cardiotoxicity, 3 months Beni-Suef University Female ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05103644 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Breast Cancer - HER2- Atorvastatin Response rate; OS; Biomarker Phase 2/3 DB01076 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), OS will be calculated from the date of randomization to the date of death up to 15 years Gustave Roussy, Cancer Campus, Grand Paris Male ADULT, OLDER_ADULT 1210 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|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/study/NCT03819101 Palliative Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y Y N France Urological Prostate Cancer Acetylsalicylic Acid; Atorvastatin OS Phase 3 DB00945; DB01076 N
NCT03971019 Survival Benefits of Statins in Breast Cancer Patients SBSBC UNKNOWN Breast Cancer Female DRUG: statins; BEHAVIORAL: Dietary intervention group (control group) DFS, Disease free survival, 5 years Peking Union Medical College Hospital Female ADULT, OLDER_ADULT 314 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT PUMCH-SBSBC 28/03/2019 28/05/2024 28/06/2024 06/03/2019 14/08/2019 https://clinicaltrials.gov/study/NCT03971019 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N China Breast Any Breast Cancer Atorvastatin; Simvastatin DFS/RFS/EFS Phase 3 DB01076; DB00641 N
NCT05483010 Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS) RECRUITING Clonal Cytopenia of Undetermined Significance|Myelodysplastic Syndromes DRUG: Atorvastatin; DRUG: Rosuvastatin Change in hs-CTRP levels in peripheral blood during statin therapy, Pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months) Washington University School of Medicine All ADULT, OLDER_ADULT 16 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 202211020 19/02/2024 31/05/2027 31/05/2027 08/01/2022 21/02/2024 https://clinicaltrials.gov/study/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 DB01076; DB01098 N
NCT06157099 Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma RECRUITING Clinical Stage IIA Cutaneous Melanoma AJCC v8|Clinical Stage IIB Cutaneous Melanoma AJCC v8|Pathologic Stage IIIA 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), Will be assessed in patients with high-risk melanoma treated with atorvastatin compared to placebo. Hypothesis testing between two arms will be performed using the stratified log-rank test with a 2-sided 0.1 level of significance. The median RFS and the rate at fixed time points (e.g. 3 year-RFS or 5 year-RFS) will be derived from the Kaplan-Meier estimate along with their 95 confidence interval. The stratified hazard ratio between the two groups along with 95 confidence interval will be obtained by fitting a stratified Cox regression model with the group variables and adjusting potential confounders., From randomization to any recurrence (local or regional [including invasive ipsilateral tumor and invasive loco-regional tumor], or distant) as ascertained by imaging and medical record review, or death due to any cause, assessed up to 5 years OHSU Knight Cancer Institute All ADULT, OLDER_ADULT 150 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT STUDY00025369; NCI-2023-03875 09/01/2024 03/01/2028 09/01/2029 12/05/2023 10/10/2024 https://clinicaltrials.gov/study/NCT06157099 Localised/Locoregional Hospital/University/Research Institute Y N N United States Skin Melanoma Atorvastatin OS; DFS/RFS/EFS; Other (specify) Phase 2 DB01076 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 UNKNOWN Breast Cancer DRUG: Letrozole; DRUG: Letrozole and atorvastatin; DRUG: Fulvestrant Clinical benefit rate., Clinical benefit rate (CBR), defined as the proportion of all randomly assigned patients who have the best overall response a complete response, a partial response, or stable disease up to 24 weeks following first-line letrozole treatment alone or in combination with atorvastatin., 6 months after the last patient has been randomly assigned. Lund University Hospital Female ADULT, OLDER_ADULT 126 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/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 DB01076 N
NCT03024684 Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment SHOT ACTIVE_NOT_RECRUITING HepatoCellular Carcinoma DRUG: Atorvastatin; DRUG: Placebo Oral Tablet 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart, Recurrence rate of HCC, 3 years Chiayi Christian Hospital All ADULT, OLDER_ADULT 240 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION 105005 01/03/2017 01/01/2025 01/01/2027 19/01/2017 11/12/2024 https://clinicaltrials.gov/study/NCT03024684 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan GI Liver Cancer Atorvastatin Recurrence rate Phase 3 DB01076 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;, 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 82 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2022PHB416 01/06/2023 31/08/2025 31/10/2025 01/09/2023 07/11/2024 https://clinicaltrials.gov/study/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 DB01076 N
NCT05507398 The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer UNKNOWN Breast Cancer Female DRUG: Placebo, metformin and atorvastatin Improvement in the overall response rate, The improvement in the overall response rate (ORR) will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively, 6 months; Improvement in the pathological response, The improvement in the pathological response will be assessed in 3 arms at the end of the study using the RECIST criteria and Miller-Payne grading system respectively, 6 monthes Tanta University Female ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05507398 Localised/Locoregional Hospital/University/Research Institute Y Y N Egypt Breast Any Breast Cancer Atorvastatin; Metformin Response rate Phase 4 DB01076; DB00244 N
NCT04657237 Effect of Anesthesia on Expression of Programmed Death-1 and Programmed Death-1 Ligand in Breast Cancer UNKNOWN Programmed Cell Death 1 PROCEDURE: Thoracic Paravertebral block change in level of PD1 and PD1 ligand postoperatively, blood sample will be withdrawn and human peripheral blood monocyte cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately. For ex vivo experiments, PBMCs will be cultured with Iscove's modified Dulbecco's medium (IMDM) containing 10 human serum albumin., preoerative (day-0),1st day, and 3 rd day after surgery Assiut University Female ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04657237 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Acetaminophen Biomarker Other DB00316 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 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, Cytokeratin 5 (CK5)-expression, Baseline to 4 weeks; To evaluate and compare the pathological complete response (pCR) rates, Up to 1 month after treatment Mahmoud Ramadan mohamed Elkazzaz Female ADULT, OLDER_ADULT 160 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/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 DB00683 N
NCT06148038 CBD for Breast Cancer Primary Tumors NOT_YET_RECRUITING Breast Cancer DRUG: CBD Oral; OTHER: Control CBD and cell proliferation, To determine whether oral administration of cannabidiol (CBD) causes biological changes related to cell proliferation (using Ki67 expression as a marker) in primary tumors of breast cancer patients., 2 months; CBD and apoptosis, To determine whether oral administration of cannabidiol (CBD) causes biological changes related to apoptosis (using Ki67 expression as a marker) in primary tumors of breast cancer patients., 2 months Medical University of South Carolina All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT 103565 30/09/2024 30/09/2026 30/09/2027 28/11/2023 07/12/2024 https://clinicaltrials.gov/study/NCT06148038 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Cannabidiol Biomarker Phase 1 DB09061 N
NCT04162873 Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer SUSPENDED 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, The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. A Gaussian mixed effects regression model will be used to compare the average number of days from surgery to the initiation of radiation and adjuvant therapy between treatment and control groups. The model will contain fixed effects for treatment arm and provider and a nested random effect for patient within provider. The mean difference between treatment groups, two-sided p-value and 95 confidence interval will be calculated from the model., up to 6 months University of Utah All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT HCI124211; NCI-2019-07104; HCI124211; P30CA042014 27/11/2019 10/12/2024 10/12/2025 14/11/2019 13/02/2024 https://clinicaltrials.gov/study/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 DB00482 N
NCT02885974 Celecoxib With Chemotherapy in Localized, Muscle-Invasive Bladder Cancer BLAST ACTIVE_NOT_RECRUITING Bladder Cancer DRUG: Celecoxib; DRUG: Gemcitabine; DRUG: Cisplatin mRNA expression in pre- and post-chemotherapy tissues, Up to four 21-day cycles of chemotherapy.; Number and severity of adverse events, Until 30 days after last treatment. Baylor College of Medicine All ADULT, OLDER_ADULT 15 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT H-36486 12/01/2016 03/01/2024 09/01/2026 09/01/2016 28/05/2024 https://clinicaltrials.gov/study/NCT02885974 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Bladder Cancer Celecoxib Biomarker Phase 1 DB00482 N
NCT03498326 Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer GCRP RECRUITING Pancreatic Cancer|Chemotherapy Effect DRUG: Gemcitabine; DRUG: Gemcitabine disease free survival, the duration between the date of surgery and the date of disease relapse, Up to approximately 60 months Second Affiliated Hospital, School of Medicine, Zhejiang University All ADULT, OLDER_ADULT 480 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT SAHZhejiangU-GCRP 04/02/2018 31/03/2023 31/03/2030 13/04/2018 30/05/2018 https://clinicaltrials.gov/study/NCT03498326 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Pancreatic Cancer Celecoxib DFS/RFS/EFS Phase 2 DB00482 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, Time to death (from any cause) from randomization, 60 months Ferring Ventures Limited All ADULT, OLDER_ADULT 53 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT rAd-IFN-MM-301; 2017-003169-82 21/01/2019 29/03/2024 04/01/2026 18/10/2018 11/08/2024 https://clinicaltrials.gov/study/NCT03710876 Palliative Recurrent/Refractory Company Y N N United States Lung Malignant Mesothelioma Celecoxib OS Phase 3 DB00482 N
NCT05933980 Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer REGOTORICOX RECRUITING Colorectal Cancer|Liver Metastases|MSS DRUG: Rego+Tori+Cele ORR, objective response rate, 1 years Sun Yat-sen University All ADULT, OLDER_ADULT 44 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GIHSYSU26 19/12/2023 20/09/2025 20/12/2025 07/06/2023 02/06/2024 https://clinicaltrials.gov/study/NCT05933980 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Celecoxib Response rate; PFS; OS Phase 2 DB00482 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, Time to mortality, 1:Not applicable Medical Research Council Male CHILD, ADULT, OLDER_ADULT 11992 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT00268476 Advanced/Metastatic Hospital/University/Research Institute Y Y N United Kingdom Urological Prostate Cancer Celecoxib; Metformin; Zoledronic Acid OS Phase 2/3 DB00482; DB00244 N
NCT05281276 Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC) RECRUITING Metastatic Colorectal Cancer DRUG: chidamide; DRUG: celecoxib Maximum Feasible Dose (MFD), Maximum Feasible Dose (MFD): is defined as the highest dose for which 1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy. If the dose of Cohort 1 is not tolerable by 2 evaluable subjects, the MFD will be considered as not determined., defined as the highest dose for which 1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy, assessed up to 24 months; Pharmacokinetics profiles-(AUC0-t), Area under the plasma concentration-time curve from time zero to time t(AUC0-t), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(AUC0- ), Area under the plasma concentration-time curve from time zero to infinity(AUC0- ), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Cmax), Maximum plasma concentration(Cmax), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Tmax), Time to maximum plasma concentration(Tmax), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(T1/2), Half-life(T1/2), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Kel), Elimination rate constant(Kel), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(AUC0- ,ss), Area under the plasma concentration-time curve from time zero to time (dosing interval) at steady state(AUC0- ,ss), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Cave,ss), Average plasma concentration at steady state(Cave,ss), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Cmin,ss), Minimum (trough) plasma concentration at steady state(Cmin,ss), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Cmax,ss), Maximum (peak) plasma concentration at steady state(Cmax,ss), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(Tmax,ss), Time to maximum plasma concentration at steady state(Tmax,ss), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.; Pharmacokinetics profiles-(DF), Degree of fluctuation(DF), Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours. Taipei Medical University Shuang Ho Hospital All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT N202007026 20/09/2022 31/12/2024 31/12/2024 16/03/2022 14/12/2023 https://clinicaltrials.gov/study/NCT05281276 Advanced/Metastatic Hospital/University/Research Institute N N N Taiwan GI Colon Cancer; Rectal Cancer Celecoxib Safety and/or Dose; PFS Phase 1 DB00482 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, Tumor cells are stained using the Ki-67 monoclonal antibody. Ki-67 is measured as a percentage of positive tumor cells. The investigator will conduct three paired t-tests comparing the percent Ki-67 at baseline to the percent Ki-67 after treatment. There will be one t-test for each arm., Baseline and 1 week University of Colorado, Denver Female ADULT 42 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 08-0104.cc; NCI-2011-02967 12/08/2009 14/01/2014 12/01/2024 19/06/2013 02/05/2024 https://clinicaltrials.gov/study/NCT01881048 Localised/Locoregional Hospital/University/Research Institute Y Y N United States Breast Any Breast Cancer Celecoxib; Omega 3 Biomarker Phase 1 DB00482; DB01250 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, Proportion of patients experiencing a pCR to perioperative PD-1 antibody, 1 year Zhejiang University All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ASTRUM-REC01 22/02/2023 20/02/2024 20/02/2025 16/02/2023 13/03/2023 https://clinicaltrials.gov/study/NCT05731726 Localised/Locoregional Hospital/University/Research Institute N N N China GI Rectal Cancer Celecoxib Response rate Phase 2 DB00482 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), Adverse events will be assessed (according to CTCAE v4.0) during treatment and follow-up., until 100 days after last patient last study drug treatment; Disease free survival, To assess efficacy of neoadjuvant ipilimumab plus nivolumab in terms of disease-free survival, until 5 years after diagnosis The Netherlands Cancer Institute All ADULT, OLDER_ADULT 268 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT N16NCI 29/03/2017 12/01/2024 12/01/2024 20/01/2017 18/04/2024 https://clinicaltrials.gov/study/NCT03026140 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands GI Colon Cancer Celecoxib Safety and/or Dose; DFS/RFS/EFS Phase 2 DB00482 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, Response rate (Complete remission, partial response, stable disease =\[CR+PR+SD\]/n) 6 months after start of antiangiogenic treatment, 8 years Medical University of Vienna All CHILD, ADULT 100 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MUV-MEMMAT-01 04/01/2014 04/01/2030 04/01/2030 19/05/2011 21/10/2024 https://clinicaltrials.gov/study/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 DB00482; DB01023 N
NCT03896113 Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma CELEBRIDO UNKNOWN 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 ., Reduction of Tumoral IDO expression after Celecoxib treatment by immunohistochemistry, digital identification of the cells and phenotype and computer count of IDO positive cells inside de tumour (then total number compared before and after the 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 , it is considered as (-).Based on animal models, the treatment with celecoxib should decreases IDO expression in tumoural cells, allowing an immune cells tumoural's infiltration., after 15 days of celecoxib administration; 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., Observed the modification of the T cell tumoral's infiltration after the celecoxib treatment by immunohistochemistry, digital identification of the cells and phenotype and computer count of the different T cells population inside de tumour (then total number compared before and after the treatment). The number of CD4 and CD8 T cells will be counted before and after the treatment and the median of all the sample before and after the treatment will be compared to assess if there is a significant difference of total number of T cells before and after the treatment. Unit= nombre of CD4 and CD8 T Cells. Based on animal model, the investigators expect to have a significant increase of T cells infiltration after the celecoxib treatment, after 15 days of celecoxib administration Cliniques universitaires Saint-Luc- Universit Catholique de Louvain Female ADULT, OLDER_ADULT 48 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT LUC19-001 13/11/2019 30/06/2022 30/06/2022 29/03/2019 01/10/2020 https://clinicaltrials.gov/study/NCT03896113 Localised/Locoregional Hospital/University/Research Institute N N N Belgium Gynaecological Endometrial Cancer Celecoxib Biomarker Phase 2 DB00482 N
NCT04093323 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma RECRUITING 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), Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be carried out by an exact binomial test of a proportion within a Simon two-stage design., At 12 weeks Roswell Park Cancer Institute All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT I 82419; NCI-2019-05911; I 82419; P01CA234212 20/11/2024 22/11/2025 22/11/2025 18/09/2019 08/02/2024 https://clinicaltrials.gov/study/NCT04093323 Recurrent/Refractory Hospital/University/Research Institute N N N United States Skin Melanoma Celecoxib Response rate Phase 2 DB00482 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: Cohort 1: Neoadjuvant treatment with toripalimab plus celecoxib for 3 months; DRUG: Cohort 1: Neoadjuvant treatment with toripalimab monotherapy for 3 months; DRUG: Cohort 2: Neoadjuvant treatment with toripalimab plus celecoxib for 6 months; DRUG: Cohort 2: Neoadjuvant treatment with toripalimab monotherapy for 6 months Pathological complete response (pCR) rates, Proportion of patients experiencing a pCR to perioperative PD-1 antibody, 1 year Sun Yat-sen University All ADULT, OLDER_ADULT 150 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT GIHSYSU-14 05/10/2019 04/01/2027 04/01/2030 24/04/2019 15/07/2024 https://clinicaltrials.gov/study/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 DB00482 N
NCT03864575 An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced Cold Solid Tumors NICE-COMBO UNKNOWN Metastatic Cancer DRUG: Celecoxib 400 mg objective response rate, To evaluate the objective response rate (ORR) of Celecoxib in combination with anti-PD1 antibodies, at week 12 from onset of treatment Cliniques universitaires Saint-Luc- Universit Catholique de Louvain All ADULT, OLDER_ADULT 68 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT LUC-19-002 15/08/2019 15/06/2021 15/06/2021 03/06/2019 07/12/2019 https://clinicaltrials.gov/study/NCT03864575 Advanced/Metastatic Hospital/University/Research Institute N N N Belgium Multiple cancer types Multiple cancer types Celecoxib Response rate Phase 2 DB00482 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), To determine the maximum tolerated dose (MTD) of botensilimab when given in combination with balstilimab + triplet chemotherapy regimen (consisting of nab-paclitaxel + gemcitabine + cisplatin) + chloroquine + celecoxib to be used in Part 2-Dose Expansion. MTD will be defined at the dose of botensilimab at which no more than 1 of 6 evaluable patients experiences a dose-limiting toxicity (DLT)., 12 months; Safety and Tolerability, To evaluate the safety and tolerability of botensilimab in combination with balstilimab + triplet + chloroquine + celecoxib. Treatment-related toxicities as per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTC AE V5.0)., End of Study (up to 2 years) HonorHealth Research Institute All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT HRI-SevenTrial 12/01/2023 06/01/2025 12/01/2025 10/11/2023 10/11/2023 https://clinicaltrials.gov/study/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 DB00482; DB00608 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., The standard 3+3 design for dose escalation will be utilized. 3-6 patients will enroll at each of 4 dose levels, but enrollment to a dosing cohort will cease after observation of DLTs in 2 or more patients. A minimum of 2 to a maximum of 24 patients will be enrolled assuming all 4 dose levels require 6 patients before an MTD is determined. A total of 12 patients may be enrolled at the study defined MTD (including those used to define the MTD) to provide additional adverse event data for safety evaluation., Approximately 1 year New Approaches to Neuroblastoma Therapy Consortium All CHILD, ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT N2012-01; P01CA081403 16/01/2014 30/12/2023 30/12/2024 01/09/2014 02/09/2024 https://clinicaltrials.gov/study/NCT02030964 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Other Neuroblastoma Celecoxib; Eflornithine Safety and/or Dose Phase 1 DB00482 N
NCT03184493 Celebrex and Metformin for Postoperative Hepatocellular Carcinoma XBD UNKNOWN Liver Cancer DRUG: Celebrex plus Metformin; DRUG: Celebrex; DRUG: Metformin Number of participants with tumor recurrence, The 1-year tumor recurrence will be compared between the three groups, 1-year Guangxi Medical University All ADULT, OLDER_ADULT 200 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT03184493 Adjuvant/Maintenance Localised/Locoregional Hospital/University/Research Institute Y Y N China GI Liver Cancer Celecoxib; Metformin DFS/RFS/EFS Phase 3 DB00482; DB00244 N
NCT02432378 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines RECRUITING 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., The difference in CD8+ tumor infiltrating T cells over 3 cycles of platinum based chemotherapy plus immunotherapy compared with baseline., 8 weeks; Number of adverse events for the different combinations, 2 patients will be treated and observed for 2 cycles on each of the dose tiers to identify the acceptable dose of IFN in combination with the other protocol drugs/vaccine for the second phase of the trial., 8 weeks Roswell Park Cancer Institute Female ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT UPCI 11-128/IC 3050822; 5P01CA132714 09/04/2015 31/12/2025 06/01/2026 05/04/2015 19/09/2024 https://clinicaltrials.gov/study/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 DB00482 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 UNKNOWN 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, Tumor tissues will be collected and stored before and after treatment. The pre and post treatment tumor tissue will be analyzed semiquantitatively by immunohistochemistry for the levels of COX-2 (Cyclooxygenase-2), EGFR (epidermal growth factor receptor), TP53 (Tumor protein 53) and VEGF (Vascular endothelial growth factor) expression. Their baseline gene expression and fold change after treatment will be assessed by quantitative real time polymerase chain reaction (qPCR) using facility at TMC., baseline and 21 days Tata Memorial Hospital All ADULT, OLDER_ADULT 64 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT 830 18/08/2015 02/12/2018 04/01/2023 22/04/2016 28/04/2022 https://clinicaltrials.gov/study/NCT02748707 Localised/Locoregional Hospital/University/Research Institute Y Y N India Head and Neck Oropharyngeal Cancer Celecoxib Biomarker Phase 2 DB00482 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, CR(complete response) + PR (partial response)rate will be assessed according to the RECIST version 1.1 guidelines., 6 months Sun Yat-sen University All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GIHSYSU13 23/08/2018 20/08/2022 31/08/2025 20/08/2018 17/10/2023 https://clinicaltrials.gov/study/NCT03638297 Localised/Locoregional Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Response rate; PFS Phase 2 DB00945 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, Radiographic response to treatment will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) for participants with solid tumors via CT or MRI scan. A complete response (CR) is a disappearance of all target and non-target lesions. Partial response (PR) is at least a 30 decrease in the disease measurement compared to the baseline measurement. Stable disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest disease measurement since baseline. Progressive disease (PD) is at least a 20 increase in the disease measurement compared to baseline, or the appearance of one or more new lesions, or evidence of laboratory or clinical progression., Baseline, End of Treatment (Up to 2 years); Change in radiographic response to treatment for central nervous system (CNS) tumors, Radiographic response to treatment will be assessed for participants with CNS tumors via CT or MRI scan. Response criteria are assessed based on the lesion of the longest diameter and its longest perpendicular diameter. Development of new disease or progression in any established lesions is considered progressive disease, regardless of response in other lesions. Complete response (CR) is the the disappearance of all target lesions. Partial response (PR) is greater than or equal to 50 decrease decrease in the sum of the products of the two perpendicular diameters of all target lesions, taking into reference the baseline measurement. Stable disease (SD) is neither a sufficient decrease in the sum of the products of the two perpendicular diameters of all target lesions to qualify for PR, nor sufficient increase in a single target lesion to qualify for progressive disease (PD)., Baseline, End of Treatment (Up to 2 years) Emory University All CHILD, ADULT 60 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRB00082488 06/01/2015 02/01/2025 02/01/2025 14/10/2015 23/02/2024 https://clinicaltrials.gov/study/NCT02574728 Recurrent/Refractory Hospital/University/Research Institute N N Y United States Multiple cancer types Multiple cancer types Celecoxib; Sirolimus Response rate Phase 2 DB00482; DB00877 N
NCT01150045 Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery UNKNOWN Colorectal Cancer DRUG: celecoxib; DRUG: 5-fluorouracil; OTHER: placebo; DRUG: oxaliplatin; DRUG: leucovorin Disease-free Survival, Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo), At 3 years of follow-up Alliance for Clinical Trials in Oncology All ADULT, OLDER_ADULT 2527 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT CALGB-80702; U10CA031946; CALGB-80702; CDR0000675693 06/01/2010 28/02/2020 24/06/2010 08/06/2021 22/03/2022 https://clinicaltrials.gov/study/NCT01150045 Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N United States GI Colon Cancer Celecoxib DFS/RFS/EFS Phase 3 DB00482 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, number of patients with improved radiology, 6 months Sherief Abd-Elsalam All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT celecoxib 08/01/2018 08/01/2025 12/01/2025 24/08/2018 20/04/2021 https://clinicaltrials.gov/study/NCT03645187 Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt GI Colon Cancer; Rectal Cancer Celecoxib Response rate Phase 4 DB00482 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, Safety was assessed by evaluation of AEs and serious AEs according to CTCAE 5.0, 1 year; Feasibility, Feasibility was determined based on any treatment -related AEs leading to delays over 15 days or discontinous of treatment., 1 year Sun Yat-sen University All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GIHSYSU-26 18/07/2023 15/12/2024 25/12/2025 13/10/2022 12/07/2023 https://clinicaltrials.gov/study/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 DB00482 N
NCT04772846 Chloroquine for Glioblastoma. UNKNOWN Glioblastoma DRUG: Oral tablet; DRUG: Placebo Survival duration after surgery, Three years Egyptian Medical Syndicate All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04772846 Localised/Locoregional Collaborative Group Y N N Egypt CNS Glioblastoma Chloroquine OS Phase 1/2 DB00608 N
NCT04397679 Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma ACTIVE_NOT_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), Will summarize dermatitis status, First 3 months of adjuvant therapy phase Barbara Ann Karmanos Cancer Institute All ADULT, OLDER_ADULT 2 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2018-148; P30CA022453 08/12/2021 27/04/2025 27/04/2026 21/05/2020 26/03/2024 https://clinicaltrials.gov/study/NCT04397679 Any/All Stages Hospital/University/Research Institute N N N United States CNS Glioblastoma Chloroquine Safety and/or Dose Phase 1 DB00608 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., Determine a dose at which no more than one patient out of up to 6 patients experiences a highly probable or probably drug-related DLT, during the 28-day DLT period., 28 days; Describe the safety profile of the antibiotic combinations along with enzalutamide in Phase I., Causality and grading severity of each adverse event related to the investigational agents according to the NCI CTCAE v5.0., 28 days; Determine the response rate of the antibiotic combinations in patients with mCRPC in Phase II., Anti-tumour activity will be defined by response rate on the basis of the following outcomes. If any of the following occur, patients will be considered to have responded:* PSA decline 50 criteria confirmed 4 weeks or later, and/or* Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease., 28 days Institute of Cancer Research, United Kingdom Male ADULT, OLDER_ADULT 39 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CCR5461 11/02/2023 30/06/2024 31/07/2025 13/11/2023 13/11/2023 https://clinicaltrials.gov/study/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 DB00537; DB01233 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, Achievement of overall immune response, defined as activation of one or more of the following T cell markers: HLA-DR, CD38, CD25, KI67, and CD69; activation is defined as an increase of 20 or more over baseline in percentage of T cells expressing the marker. Comparison to be made between tissue biopsy taken following chemotherapy (and prior to antibiotics and pembrolizumab) and definitive surgical specimen., at day 43; Achievement of overall immune response, Achievement of overall immune response, defined as activation of one or more of the following T cell markers: HLA-DR, CD38, CD25, KI67, and CD69; activation is defined as an increase of 20 or more over baseline in percentage of T cells expressing the marker. Comparison to be made between tissue biopsy taken following chemotherapy (and prior to antibiotics and pembrolizumab) and definitive surgical specimen., day 102 Icahn School of Medicine at Mount Sinai All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY-21-01814 16/03/2023 08/01/2027 04/01/2028 18/07/2022 15/10/2024 https://clinicaltrials.gov/study/NCT05462496 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Ciprofloxacin; Metronidazole Other (specify) Phase 2 DB00537; DB01233 N
NCT04523987 A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. UNKNOWN Metastatic Pancreatic Ductal Adenocarcinoma DRUG: Ciprofloxacin Antitumor Effect - Solid Tumors, Patients are be re-evaluated for response every 8-12 weeks ( 10 days), per standard-of-care.Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in RECIST., 4 years National University Hospital, Singapore All ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT PA02/07/18 22/02/2019 02/01/2023 02/01/2024 24/08/2020 24/08/2020 https://clinicaltrials.gov/study/NCT04523987 Advanced/Metastatic Hospital/University/Research Institute N N N Singapore GI Pancreatic Cancer Ciprofloxacin Response rate Phase 1 DB00537 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), ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry ( / ratio 4:1 or 1:2 for and patients, respectively, after counting 100 plasma cells). Complete Response (CR) negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5 plasma cells in bone marrow aspirates. Very good partial response (VGPR) serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Partial response (PR): 50 reduction of serum M-protein plus reduction in 24 h urine M-protein by 90 or to \<200 mg per 24 h., 4 weeks after CAR T-cells infusion (up to 14 weeks) The First Affiliated Hospital of Soochow University All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT BiRd-01 19/10/2017 31/01/2023 31/01/2025 27/02/2020 25/10/2021 https://clinicaltrials.gov/study/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 DB01211 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; DRUG: Dexamethasone; DRUG: Lenalidomide Response to Car-BiRD Treatment., The best response for all patients who had at least one dose of drug was measured.Response categories:Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).The response is evaluated based on the IMWG criteria., From baseline to best response, up to 116 weeks. Weill Medical College of Cornell University All ADULT, OLDER_ADULT 74 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 1108011903 03/01/2012 06/07/2016 03/01/2026 21/03/2012 22/03/2017 26/09/2024 https://clinicaltrials.gov/study/NCT01559935 Any/All Stages Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 2 DB01211 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), The MTD is defined as the highest dose tested in which fewer than 33 of patients experience a dose limiting toxicity and at least 6 patients have been treated at that dose. The MTD will be the recommended Phase 2 dose, provided that other safety considerations are acceptable., 28 days Joseph Tuscano All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 728937; UCDCC#253; X16043; UCDCC#253; PO-TR-MM-PI-004614 10/01/2015 08/01/2025 12/01/2025 09/07/2015 19/09/2024 https://clinicaltrials.gov/study/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 DB01211 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, Very Good Partial Response or better defined as the proportion of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle., 8 months Weill Medical College of Cornell University All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 19-12021155 28/10/2021 09/01/2025 09/01/2030 03/10/2020 26/06/2024 https://clinicaltrials.gov/study/NCT04302324 Recurrent/Refractory Hospital/University/Research Institute N N N United States Other Haem-onc Multiple Myeloma Clarithromycin Response rate Phase 2 DB01211 N
NCT02343042 Selinexor and Backbone Treatments of Multiple Myeloma Patients STOMP 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; DRUG: Mezigdomide Phase 1 (Dose-escalation): Maximum Tolerated Dose (MTD), MTD for once weekly and twice weekly selinexor dose cohorts in the 11 Arms will be evaluated., 12 months; Phase 1 (Dose-escalation): Recommended Phase-2 dose (RP2D), RP2D for each Arm will be determined., 12 months; Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor, Cmax of selinexor over a dosing interval when given with and without clarithromycin., Pre-dose, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin); Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor, Total exposure of selinexor in the blood (AUC0-last) from the time of dosing to the last measurable concentration collected when given with and without clarithromycin., Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin); Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf), Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post-dose on Day 1 (without clarithromycin) and Day 8 (with clarithromycin); Phase 2 (Expansion): Overall response rate (ORR), ORR for each Arm independently. ORR to include stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to the International Myeloma Working Group (IMWG) criteria., 12 months; Phase 2 (Expansion): Duration of response (DOR), Duration of response for each Arm. DOR is defined as the number of days from the date of the first evidence of objective response until progression., 12 months; Phase 2 (Expansion): Clinical Benefit Rate (CBR), CBR is defined the point estimate of the percentage of patients in that arm who have a response of sCR, CR, VGPR, PR or Minimal response (MR), as assessed by IMWG criteria., 12 months Karyopharm Therapeutics Inc All ADULT, OLDER_ADULT 300 INDUSTRY Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT KCP-330-017 10/01/2015 04/01/2027 04/01/2027 21/01/2015 19/09/2024 https://clinicaltrials.gov/study/NCT02343042 Recurrent/Refractory Company N Y N United States Other Haem-onc Multiple Myeloma Clarithromycin Safety and/or Dose; Response rate Phase 1/2 DB01211 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, Kaplan-Meier survival estimates, 5 year Mercy Medical Center All ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MMC-2014-53 01/01/2015 12/01/2024 12/01/2024 03/12/2015 19/11/2024 https://clinicaltrials.gov/study/NCT02387203 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Other GI Clarithromycin; Lansoprazole PFS; OS Phase 2 DB01211; DB00555 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, Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria., at 9 months after the start of treatment Memorial Sloan Kettering Cancer Center All ADULT, OLDER_ADULT 23 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 12-138 12/01/2012 12/01/2025 12/01/2025 12/10/2012 07/03/2024 https://clinicaltrials.gov/study/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 DB01211 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, The primary outcome measure is tumour response assessed according to the Revised Response Criteria for Malignant Lymphoma, either clinically (including appropriate imaging procedures) or endoscopically and histologically (in patients affected by gastric lymphoma, according to the GELA scoring system)., During the active treatment period after the 3rd cycles of both drugs administration International Extranodal Lymphoma Study Group (IELSG) All ADULT, OLDER_ADULT 44 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IELSG40 04/03/2017 13/11/2019 11/01/2029 25/01/2017 28/08/2024 https://clinicaltrials.gov/study/NCT03031483 Recurrent/Refractory Collaborative Group N N N Italy Lymphoma Lymphoma - Other Clarithromycin Response rate Phase 2 DB01211 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, kIU/L, 14 weeks University Hospital, Linkoeping Female ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT The TABANETOC-trial; 2021-000135-31 07/12/2022 31/12/2026 31/12/2026 17/03/2022 25/01/2024 https://clinicaltrials.gov/study/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, PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention, 12 months; The number of VTE events during the trial, All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis)., 12 months Michalis Karamouzis All ADULT, OLDER_ADULT 450 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION imPaCT-PRO-01 02/10/2022 31/12/2024 31/12/2024 01/05/2022 29/03/2022 https://clinicaltrials.gov/study/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, -Adverse events will be graded by CTCAE (version 5.0)., From start of treatment through 30 days after last day of dapagliflozin treatment (estimated to be 4 months) Washington University School of Medicine All CHILD, ADULT 20 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 202210013 04/03/2023 31/08/2026 30/11/2026 30/08/2022 21/05/2024 https://clinicaltrials.gov/study/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 DB06292 N
NCT03889795 Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors ACTIVE_NOT_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, Occurrence of any Grade 3 toxicity encountered within the four weeks following the administration of C3, regardless of attribution, Up to one year Danae Hamouda, MD All ADULT, OLDER_ADULT 15 OTHER Interventional Study Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT C3 06/05/2019 30/12/2026 30/12/2027 26/03/2019 15/10/2024 https://clinicaltrials.gov/study/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 DB00390; DB00244; DB00641 N
NCT04141995 FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer ACTIVE_NOT_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, Regimen will be considered for further investigation if 14 of the 20 patients are able to undergo resection, 16 weeks University of Nebraska All ADULT, OLDER_ADULT 11 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 0668-19-FB; 1P50CA127297-01A2 02/12/2021 02/01/2025 02/01/2025 28/10/2019 08/07/2024 https://clinicaltrials.gov/study/NCT04141995 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Digoxin Other (specify) Phase 2 DB00390 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), Within-patient change in IHC scores will be analyzed using the Wilcoxon signed-rank test. Comparisons will be made between pretreatment and post-treatment within each of the cohorts, Baseline to 30 days after last drug dose Sidney Kimmel Cancer Center at Thomas Jefferson University All ADULT, OLDER_ADULT 7 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00254; DB00244 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), from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up, 2-year from start of treatment International Extranodal Lymphoma Study Group (IELSG) All ADULT, OLDER_ADULT 34 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IELSG39 03/01/2013 05/01/2016 09/01/2025 29/03/2013 05/01/2024 https://clinicaltrials.gov/study/NCT01820910 Localised/Locoregional Collaborative Group N N N United States Lymphoma Lymphoma - Other Doxycycline PFS Phase 2 DB00254 N
NCT03116659 CTCL Directed Therapy UNKNOWN Lymphoma, T-Cell, Cutaneous DRUG: Doxycycline; DRUG: Imiquimod Pilot assessment of response., Pilot assessment of response assessed by decreased size or surface change of the 5 lesions, 1 year James J. Peters Veterans Affairs Medical Center All ADULT, OLDER_ADULT 8 FED Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT DAN-15-028 02/01/2018 30/12/2020 30/12/2020 17/04/2017 13/08/2019 https://clinicaltrials.gov/study/NCT03116659 Localised/Locoregional Hospital/University/Research Institute N N N United States Lymphoma Cutaneous T-Cell Lymphoma Doxycycline Response rate Phase 1 DB00254 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, overall survival rate at month 12 (year 1) between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy., 12 months after beginning treatment French Innovative Leukemia Organisation All ADULT, OLDER_ADULT 110 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT EPAG 2015 10/11/2018 15/06/2022 30/07/2026 27/07/2018 29/10/2024 https://clinicaltrials.gov/study/NCT03603795 Localised/Locoregional Collaborative Group Y N N France Leukemia Acute Myeloid Leukemia, Adult Eltrombopag Response rate; OS Phase 2 DB06243 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, Local progression free survival will be determined on a per lesion basis based on follow-up cross-sectional imaging and modified response evaluation criteria in solid tumors, 6 months following treatment VA Office of Research and Development All ADULT, OLDER_ADULT 93 FED Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT ONCC-008-22S; IO1CX002542 07/01/2024 31/08/2027 31/08/2028 05/03/2023 13/02/2024 https://clinicaltrials.gov/study/NCT05842174 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Liver Cancer Hydroxychloroquine PFS Phase 1/2 DB01275 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), Rate of protocol defined severe toxicity during cycle 1 (4 weeks) of combination HCQ 600mg BID and Abema (at 100 mg and 150 mg BID) in a safety cohort of 6 patients at each dose of Abema, Toxicity is assessed over the first cycle (4 weeks) of treatment; 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), Frequency of clearance of bone marrow DTCs by arm after 6 cycles of study treatment., 6 cycles (approximately 6 months) Abramson Cancer Center at Penn Medicine All ADULT, OLDER_ADULT 66 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT UPCC 10119 11/01/2021 12/01/2027 12/01/2028 24/08/2020 03/12/2024 https://clinicaltrials.gov/study/NCT04523857 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Hydroxychloroquine Biomarker Phase 2 DB01275 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), Testing the safety/tolerability of adding HCQ to Dabrafenib + Trametinib or to Trametinib, Approximately 28 days from start of therapy; Maximum Plasma Concentration, Maximum plasma concentration Dabrafenib+Trametinib+Hydroxychloroquine or Trametinib +Hydroxychloroquine, 1-4 days; Area under the curve (AUC), AUC for Dabrafenib+Trametinib+Hydroxychloroquine or Trametinib +Hydroxychloroquine, 1-4 days; Phase II: Sustained objective response rate., Number of patients who meet the better response criteria, which is a comparison of response on this current protocol therapy versus their best response to previous RAF and/or MEK inhibitor therapy, Up to approximately 2 years from the start of therapy Pediatric Brain Tumor Consortium All CHILD, ADULT 75 NETWORK Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT PBTC-055; UM1CA081457; NCI-2019-06216; PBTC-055; PBTC-055 17/01/2020 30/08/2026 30/06/2029 17/12/2019 04/05/2024 https://clinicaltrials.gov/study/NCT04201457 Recurrent/Refractory Collaborative Group N N Y United States CNS Glioma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB01275 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), Maximum tolerated dose (MTD) for FHQ which is defined as the highest dose level in which the investigators have treated 6 patients with at most 1 experiencing dose limiting toxicities (DLT). A maximum of 18 patients (3x6) will be accrued for dose finding., From first dose to 30 days after treatment has been discontinued or until death, whichever occurs first.; Phase II - Rate of grade IIb or better histopathological response, The number of patients that have a rate of grade IIb or better histopathological response., Up to 4 months West Virginia University All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2103260669 16/07/2021 06/01/2025 06/01/2028 06/03/2021 01/12/2024 https://clinicaltrials.gov/study/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 DB01275 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, up to 3 years Changhoon Yoo All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT05083780 Advanced/Metastatic Company N N N Korea, Republic of GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose; Response rate; PFS; OS Phase 1 DB01275 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., To determine the recommended phase II dose (RP2D) hydroxychloroquine in combination with trametinib., At 28 days University of Utah All ADULT, OLDER_ADULT 39 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT HCI116898 18/01/2019 18/01/2025 18/01/2026 31/01/2019 19/04/2024 https://clinicaltrials.gov/study/NCT03825289 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose Phase 1 DB01275 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), To determine the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria for the combination of encorafenib, cetuximab, and hydroxychloroquine. This will be assessed based on RECIST1.1 criteria by cross-sectional imaging done every 2 cycles., Within 30 days (+/- 7 days) of coming off treatment Northwestern University All ADULT, OLDER_ADULT 43 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/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 DB01275 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), The MTD is defined as the dose combination at which 30 of the patients experience a dose-limiting toxicity (DLT) by the end of Cycle 2, 16 weeks Columbia University All ADULT, OLDER_ADULT 175 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT AAAS4165; ML41472 02/12/2020 06/01/2024 09/01/2024 01/02/2020 28/02/2024 https://clinicaltrials.gov/study/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 DB01275 N
NCT03754179 Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma COMBI-R2 UNKNOWN Melanoma DRUG: Dabrafenib; DRUG: Trametinib; DRUG: Hydroxychloroquine Ph. 1: incidence of adverse events of DAB, TRA and HCQ, Adverse events graded by the Common Terminology Criteria of Adverse Events version 4 (CTCAE v4), 1 year; Ph. 2 Arm A: objective response rate (ORR) of DAB, TRA and HCQ, Objective response rate (ORR; defined as the percentage of subjects with a confirmed complete response \[CR\] or partial response \[PR\] at any time per Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1 \[Eisenhauer 2009\])., 2 years Universitair Ziekenhuis Brussel All ADULT, OLDER_ADULT 63 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2017-BN-004 23/01/2018 12/01/2021 07/01/2022 27/11/2018 28/04/2021 https://clinicaltrials.gov/study/NCT03754179 Advanced/Metastatic Hospital/University/Research Institute N Y N Belgium Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB01275 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), Up to 21 days; Disease control rate (Phase II), At 4 months M.D. Anderson Cancer Center All CHILD, ADULT, OLDER_ADULT 31 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2018-0224; NCI-2018-01414; 2018-0224 28/01/2019 13/09/2025 13/09/2025 26/07/2018 19/08/2024 https://clinicaltrials.gov/study/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 DB01275 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, PAR-4 levels measured via serum or plasma blood sample, 7 timepoints: Baseline, 2 weeks prior to radiation/surgery, 30-, 60- 90-days post-HCQ initiation; and follow-up timepoints at 6- and 12-months Patrick Hensley Male ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 50146 - MCC-19-GU-72 12/03/2019 03/08/2024 18/11/2026 07/08/2019 04/10/2024 https://clinicaltrials.gov/study/NCT04011410 Advanced/Metastatic Hospital/University/Research Institute N N N United States Urological Prostate Cancer Hydroxychloroquine Biomarker Phase 2 DB01275 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, The percentage of patients free of disease progression at 12 weeks from starting treatment into the study as determined by radiographic disease assessments per RECIST version 1.1., Twelve weeks from starting treatment. Cancer Trials Ireland All ADULT, OLDER_ADULT 22 NETWORK Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CTRIAL-IE 20-27; 2021-006276-16 31/05/2023 30/09/2025 30/06/2026 26/08/2022 26/09/2024 https://clinicaltrials.gov/study/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 DB01275 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 study aims to evaluate the safety dose of the combination of hydroxychloroquine and CDK4/6 inhibitors in patients with solid tumors. The safety dose was according to 3+3 dose escalation principle.In this study, Dose-limiting toxicity (DLT) was defined as drug-related adverse reactions (according to the NCI CTC 5.0 grading criteria) after treatment: Grade II liver and kidney injury, grade III other non-hematological toxicity, and grade IV hematological toxicity., 12 months; the recommended phase II dose, The study aims to evaluate the recommended phase II dose of the combination of hydroxychloroquine and CDK4/6 inhibitors in patients with solid tumors., 12 months Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|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/study/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 DB01275 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, To determine the MTD and preliminary safety of HCQ when administered in conjunction with one of the following treatments in patients with advanced melanoma:* HCQ administered in combination with nivolumab; or* HCQ administered in combination with nivolumab and ipilimumab followed by maintenance nivolumab, From first dose of protocol treatment to 16 to 32 weeks; Phase 2: Objective Response Rate (ORR), To assess the ORR as measured by RECIST v1.1. in subjects with advanced melanoma, 12 months Ravi Amaravadi, MD All ADULT, OLDER_ADULT 94 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT UPCC 01620; IRB#835033 21/10/2020 30/10/2025 30/10/2025 07/09/2020 21/11/2024 https://clinicaltrials.gov/study/NCT04464759 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB01275 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), Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in patients with solid tumors treated under this protocol. ORR is defined as the percentage of patients with documented complete response (CR) plus the percentage of patients with documented partial response (PR). ORR will be reported with the corresponding exact confidence intervals., Time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first) Northwestern University All ADULT, OLDER_ADULT 94 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NU 22MH03; NCI-2023-00070; STU00218203; NU 22MH03; P30CA060553 03/08/2023 01/04/2028 03/04/2030 17/02/2023 03/10/2023 https://clinicaltrials.gov/study/NCT05733000 Recurrent/Refractory Hospital/University/Research Institute N N N United States Multiple cancer types Any solid tumours Hydroxychloroquine Response rate Phase 2 DB01275 N
NCT00977470 Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations UNKNOWN Non-small Cell Lung Cancer DRUG: Erlotinib; DRUG: Hydroxychloroquine Median Progression Free Survival, A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20 increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan., From start of treatment until report of disease progression, assessed up to 10 years.; Nine-month Progression-free Survival Rate, This trial can detect a difference in proportions alive without progression at 9 months from 50 in the erlotinib arm to 77 in the erlotinib plus hydroxychloroquine (HCQ) arm, using an alpha of 0.15 and power of 85 , using the two-sided Likelihood Ratio test. Progression is defined as at least a 20 increase in the size of existing lesions or the appearance of one or more new lesions., Nine months Massachusetts General Hospital All ADULT, OLDER_ADULT 76 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT00977470 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Lung Non-Small Cell Lung Cancer Hydroxychloroquine PFS Phase 2 DB01275 N
NCT03037437 Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer ACTIVE_NOT_RECRUITING Hepatocellular Cancer DRUG: Sorafenib (SOR); DRUG: Hydroxychloroquine (HCQ) Time to tumor progression evaluated via tumor imaging, Computerized axial tomography (CAT) Scan or Magnetic resonance imaging (MRI) will be done at Screening, then every other cycle and evaluated using RECIST version 1.1, Through study completion, an average of 1 year The University of Texas Health Science Center at San Antonio All ADULT, OLDER_ADULT 64 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT CTMS 16-0076; HSC20160515H 16/02/2017 06/01/2025 06/01/2025 31/01/2017 13/08/2024 https://clinicaltrials.gov/study/NCT03037437 Advanced/Metastatic Hospital/University/Research Institute N Y N United States GI Liver Cancer Hydroxychloroquine PFS Phase 2 DB01275 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), Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Tumor measurements will be performed every 8 weeks. Response rate will be estimated, and a 90 exact confidence interval will be reported using the Clopper-Pearson method., From date of study entry until date of first documented progression or death from any cause whichever comes first up to 100 months. Emory University All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT04524702 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine; Paricalcitol Response rate Phase 2 DB01275; DB08439 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, Feasibility of administering PHL when given in the window between neoadjuvant chemo-radiotherapy and surgery. Feasibility is defined as the ability to tolerate a minimum of 4 weeks of PHL treatment without interfering with patient's planned surgery., 4 weeks Fox Chase Cancer Center All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 20-1085; GI-174; 1R21CA252535-01A1 20/10/2021 31/03/2025 31/12/2025 05/09/2022 25/06/2024 https://clinicaltrials.gov/study/NCT05365893 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine; Losartan; Paricalcitol Safety and/or Dose Phase 1 DB01275; DB00455; DB08439 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, Percentage of participants who have a partial response or complete response to study treatment., Start of study treatment to end of study, up to 48 months. University Health Network, Toronto All ADULT, OLDER_ADULT 155 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT Targeting DTP in mCRC; 22-5689 08/09/2023 24/04/2026 24/10/2026 05/06/2023 02/09/2024 https://clinicaltrials.gov/study/NCT05843188 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Colon Cancer; Rectal Cancer Hydroxychloroquine Response rate Phase 2 DB01275 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), Will employ the Bayesian optimal interval (BOIN) design to find the MTD., Up to 30 days M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 39 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2019-0191; NCI-2019-04991; 2019-0191 22/10/2019 31/12/2026 31/12/2026 18/10/2019 19/11/2024 https://clinicaltrials.gov/study/NCT04132505 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Hydroxychloroquine Safety and/or Dose Phase 1 DB01275 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, Evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy., 6 months HonorHealth Research Institute All ADULT, OLDER_ADULT 19 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT HCQ NABPLAGEM-NEO 2020 12/01/2020 21/02/2024 30/12/2024 16/12/2020 15/10/2024 https://clinicaltrials.gov/study/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 DB01275 N
NCT03979651 MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma CHLOROTRAMMEL UNKNOWN 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), DLTs will be determined weekly during the first cycle of treatment (28 days) in order to choose the optimal dose for the phase II, 28 days; Percentage of patients with a partial or complete response to treatment, Percentage of patients with a partial or complete response to treatment according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1 which allows the Evaluation of the Overall Response Rate (ORR) based on 3 main criteria: patients' tumor improves ( responds ), stays the same ( stabilizes ), or worsens ( progresses ) during treatment. The comparison of target lesions will be based on a Computed Tomography (CT) scan performed after two cycles of treatment (56 days) to those present on the base line CT prior to treatment initiation., 56 days Hospices Civils de Lyon All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|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/study/NCT03979651 Advanced/Metastatic Hospital/University/Research Institute N N N France Skin Melanoma Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB01275 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, Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0., 21 days; Dose-limiting toxicity rate, Will be assessed by CTCAE version 4.0., 21 days National Cancer Institute (NCI) All ADULT, OLDER_ADULT 62 NIH Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCI-2012-00084; NCI-2012-00084; 051105; CDR0000717546; CINJ-051105; 8983; 8983; P30CA072720; U01CA132194; UM1CA186716 23/11/2011 14/02/2020 03/07/2025 28/11/2011 19/09/2024 https://clinicaltrials.gov/study/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 DB01275 N
NCT03972748 Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin. UNKNOWN Basal Cell Carcinoma|Hedgehog Pathway DRUG: Itraconazole 200 mg clinical response, tumor area response registered through dermatologic evaluation, 60 days; hedgehog pathway activity, Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment., 60 days Hospital de Clinicas de Porto Alegre All ADULT, OLDER_ADULT 28 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT03972748 Localised/Locoregional Hospital/University/Research Institute N N N Brazil Skin Basal Cell Carcinoma Itraconazole Response rate Other DB01029 N
NCT05563766 A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer RECRUITING Esophageal Adenocarcinoma|Esophageal Squamous Cell Carcinoma|Gastroesophageal Junction Carcinoma DRUG: Itraconazole Rate of pathological complete response with itraconazole, Historically, the pathCR rate at time of esophagectomy is 25 . The investigators have powered our study to detect a 15 or more improvement in pathCR rate following treatment with itraconazole. By inhibiting pathways that mediate chemoradiation resistance, the investigators anticipate an improved pathCR rate., 20 weeks VA Office of Research and Development All ADULT, OLDER_ADULT 78 FED Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ONCB-016-21F; I01CX002349 10/01/2024 30/04/2029 15/06/2029 10/03/2022 21/11/2024 https://clinicaltrials.gov/study/NCT05563766 Localised/Locoregional Local/National government N N N United States GI Esophageal Cancer Itraconazole Response rate; Biomarker Phase 2 DB01029 N
NCT02749513 Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients UNKNOWN Esophageal Cancer DRUG: Itraconazole Inhibition of Hedgehog pathway signaling as measured by real-time PCR., mRNA expression levels as measured by real-time PCR of Hedgehog pathway ligands and target genes will be compared between baseline and post-itraconazole treatment., 2-3 weeks Dallas VA Medical Center All ADULT, OLDER_ADULT 18 FED Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER 15-084 01/01/2016 09/01/2019 10/01/2022 25/04/2016 11/04/2021 https://clinicaltrials.gov/study/NCT02749513 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Esophageal Cancer Itraconazole Biomarker Phase 1 DB01029 N
NCT03664115 Itraconazole in Non Small Cell Lung Cancer UNKNOWN Lung Cancer DRUG: Itraconazole 200 mg; DRUG: Chemotherapy one year progression free survival, time from treatment initiation to either progression, death from any cause or lost to follow up., 1 year Ain Shams University All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 17585 07/02/2018 12/02/2019 12/02/2020 09/10/2018 09/10/2018 https://clinicaltrials.gov/study/NCT03664115 Advanced/Metastatic Hospital/University/Research Institute Y N N Egypt Lung Non-Small Cell Lung Cancer Itraconazole PFS Phase 2 DB01029 N
NCT04481100 CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer UNKNOWN Esophageal Neoplasm|Esophageal Diseases|Esophageal Squamous Cell Carcinoma DRUG: itraconazole Objective response rate (ORR), ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1, 4-8 weeks Hangzhou Cancer Hospital All ADULT, OLDER_ADULT 38 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 20200707 10/01/2020 31/07/2021 31/07/2023 22/07/2020 14/10/2020 https://clinicaltrials.gov/study/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 DB01029 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)., PFS on matched targeted therapy (PFS2) is defined as the time from start of matched targeted therapy to disease progression, defined by RECIST 1.1 criteria, or death from any cause. PFS on prior therapy (PFS1) is defined as the time from start of the prior treatment to disease progression defined by RECIST 1.1 criteria, From baseline until the date of documented disease progression or 12 months after the start of targeted therapy. Gynaecologisch Oncologisch Centrum Zuid Female ADULT, OLDER_ADULT 148 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/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 DB01029 N
NCT03273231 The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection UNKNOWN Colorectal Cancer DRUG: Ketamine; DRUG: Saline natural killer cell cytotoxicity, Natural killer cell cytotoxicity is measured with NK Vue Kit (ATGen, Gyeonggi-do, Korea)., Baseline; natural killer cell cytotoxicity, Natural killer cell cytotoxicity is measured with NK Vue Kit (ATGen, Gyeonggi-do, Korea)., 1 hour after surgery; natural killer cell cytotoxicity, Natural killer cell cytotoxicity is measured with NK Vue Kit (ATGen, Gyeonggi-do, Korea)., postoperative day 1; natural killer cell cytotoxicity, Natural killer cell cytotoxicity is measured with NK Vue Kit (ATGen, Gyeonggi-do, Korea)., postoperative day 2 Yonsei University All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT03273231 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Colon Cancer; Rectal Cancer Ketamine Biomarker Other DB00602 N
NCT03763396 Azoles Targeting Recurrent High Grade Gliomas NOT_YET_RECRUITING Brain Tumor, Recurrent|Cancer, Advanced|Glioma of Brain DRUG: Ketoconazole (KCZ); DRUG: Posaconazole (PCZ) Intratumoral concentrations of KCZ or PCZ, Following either single dose regimen(4-24hours prior to surgery) or repeated dose regimen of KCZ( for 2-5 days) or PCZ( for 7-10 days); Plasma concentrations of KCZ or PCZ, Following either single dose regimen(4-24hours prior to surgery) or repeated dose regimen of KCZ(for 2-5 days) or PCZ(for 7-10 days) University Health Network, Toronto All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER 18-5097 06/01/2024 06/01/2025 06/01/2027 12/04/2018 03/08/2024 https://clinicaltrials.gov/study/NCT03763396 Recurrent/Refractory Hospital/University/Research Institute N Y N Canada CNS Glioma Ketoconazole; Posaconazole Other (specify) Phase 1 DB01221; DB01263 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, Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration., Baseline and 18 months after study drug administration Weill Medical College of Cornell University Male ADULT, OLDER_ADULT 55 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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 24/05/2024 https://clinicaltrials.gov/study/NCT00859781 Recurrent/Refractory Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Ketoconazole DFS/RFS/EFS Phase 2 DB01221 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, Ovarian cancer cells retrieved from the post-debulked peritoneal cavity after three intravenous dosings of ketorolac will be evaluated for GTPase activity using cell-based laboratory assays, Within 4 weeks of peritoneal cell collection New Mexico Cancer Care Alliance Female ADULT, OLDER_ADULT 21 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB01009 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, Plasma multiplex technology using cytometric bead arrays, Up to 24 hours after surgery; To detect a reduced increase in systemic neurotransmitters (from baseline to up to 24 hours after surgery) using peri-operative pregabalin, Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS), Up to 24 hours after surgery; Change in biomarkers of metastasis at surgery from baseline, Transcriptome profile and bioinformatic analysis, At surgery; Change in tumoral immune cells recruitment at surgery from baseline, Characterization of Tumour-infiltrating leukocyte subpopulations using RNA sequencing analysis from fresh frozen tissue sections, At surgery; Change in tumoral neurogenesis at surgery from baseline, Level of neurogenesis markers using RNA sequencing analysis from fresh frozen tissue section, At surgery; Change in tumoral neurotransmitters level at surgery from baseline, Using RNA sequencing analysis from fresh frozen tissue sections, At surgery; Change in Peripheral Blood Mononuclear Cells at surgery from baseline, Fluorescence activated cell sorting (FACS) analysis, At surgery; Change in systemic neuro-inflammatory mediators at surgery from baseline, Plasma multiplex technology using cytometric bead arrays, At surgery; Change in systemic neurotransmitters at surgery from baseline, Plasma multiplex technology using cytometric bead arrays, At surgery Jules Bordet Institute Female ADULT, OLDER_ADULT 112 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER IJB-KEPREST-2022 20/02/2024 20/07/2026 12/01/2026 29/11/2023 29/11/2023 https://clinicaltrials.gov/study/NCT06150898 Localised/Locoregional Hospital/University/Research Institute N N N France Breast Breast Cancer - ER/HR+ Ketorolac Biomarker Phase 2 DB01009 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, Clopper Pearson binomial 95 confidence intervals will be calculated., Up to 1 year City of Hope Medical Center All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 19418; NCI-2020-01962; 19418 27/11/2020 14/02/2027 14/02/2027 08/11/2020 08/06/2024 https://clinicaltrials.gov/study/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 DB17289 N
NCT04997993 Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies RECRUITING PTEN-null Advanced Solid Tumors DRUG: Leflunomide Number of participants with Dose-limiting toxicities, Grade 3 or higher non-hematologic toxicity, Any death not clearly due to the underlying disease, Cases defined by Hy's law, Grade 4 neutropenia or thrombocytopenia \> 7 days, Grade 3 thrombocytopenia with clinically significant bleeding, Febrile neutropenia, 1 month; Number of Dose-limiting toxicities, Grade 3 or higher non-hematologic toxicity Any death not clearly due to the underlying disease Cases defined by Hy's law Grade 4 neutropenia or thrombocytopenia \> 7 days Grade 3 thrombocytopenia with clinically significant bleeding Febrile neutropenia, 1 month Deborah Doroshow All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GCO 20-2528 13/12/2023 09/01/2026 09/01/2026 08/10/2021 25/06/2024 https://clinicaltrials.gov/study/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 DB17289 N
NCT02815410 Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients UNKNOWN Glioblastoma Multiforme DRUG: levetiracetam 6 months Progression free survival, from the first operation to following 6 months Seoul National University Hospital All ADULT, OLDER_ADULT 73 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT cykim 07/01/2016 06/01/2019 06/01/2022 28/06/2016 28/06/2016 https://clinicaltrials.gov/study/NCT02815410 Localised/Locoregional Hospital/University/Research Institute N N N Korea, Republic of CNS Glioblastoma Levetiracetam PFS; OS Phase 2 DB00848 N
NCT04710290 A Cohort Study of Beta-Glucan or Beta-Glucan Compound in Metastatic Cancers UNKNOWN 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 7days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul, 14-21 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 7 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 21-28 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 14-21 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 7 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 14-21 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 7 days; 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 units of white blood cells, neutrophils, and lymphocytes are /ul., 15 days; the change of total white blood cells, neutrophils, and lymphocytes at 2nd month after chemotherapy, from day 22 of 6th cycle of chemotherapy, the units of white blood cells, neutrophils, and lymphocytes are /ul., 63 days; 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, total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions.The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent., 6-8 weeks; 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, total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent., 8-10 weeks; 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, total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent., 9 -10 weeks; the change of lymphocyte surface markers percentage at day 7 of 2nd chemotherapy, from baseline., the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i, 4-5 weeks; the change of lymphocyte surface markers percentage at day 14 of 2nd chemotherapy, from day 7 of E-DA Hospital All ADULT, OLDER_ADULT 90 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00367 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, Study participants will be contacted by study team via phone or e-mail, 3 years Institutul Regional de Gastroenterologie Hepatologie Prof. dr. Octavian Fodor All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT04449289 Localised/Locoregional Hospital/University/Research Institute Y N N Romania GI Pancreatic Cancer Lidocaine Recurrence rate Phase 2 DB00130 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, The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3., Baseline; Trial retention, The number of participants who consent to participate who remain in the study until the end of follow up at 12 months., 12 months post randomisation; The completion of data collection instruments, on eCRF, 6 months post randomisation; The completion of data collection instruments, on eCRF, 12 months post randomisation; Participant's feedback of study experiences, 10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement., Day 3 hospital stay; Clinical staff feedback of study experiences, 10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement., Day 3 hospital stay; Patients' reasons to refuse consent., Patients who refuse consent will be asked for their reasons at the point of recruitment only, Baseline; Clinicians' reasons for not recruiting patients., Clinicians will be asked their reasons for not recruiting patients, Screening Imperial College London All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00130 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, Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation, Baseline and 48 hours after operation; Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery, Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation, Baseline and 48 hours after operation; Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery, Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation, Baseline and 48 hours after operation; Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery, Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation, Baseline and 48 hours after operation General Hospital of Ningxia Medical University Female ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05560035 Any/All Stages Hospital/University/Research Institute Y N N China Gynaecological Cervical Cancer Lidocaine Biomarker Other DB00130 N
NCT04162535 Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery UNKNOWN Colorectal Cancer DRUG: Lidocaine 1 Injectable Solution; BIOLOGICAL: Blood extraction; DRUG: Sevoflurane; DRUG: Propofol Evaluation of the antiproliferative and apoptotic effects of anesthetic agents, The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6).The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers., up to 4 years; Evaluation of patients serum on cell culture, The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay.The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation.The concentrations will be measured in mcg/ml., up to 1 week Iuliu Hatieganu University of Medicine and Pharmacy All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04162535 Localised/Locoregional Hospital/University/Research Institute Y Y N Romania GI Colon Cancer; Rectal Cancer Lidocaine Biomarker Phase 1 DB00130 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, The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms., Until 3 years from participant index surgery date; Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine, The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms., Until 3 years from participant index surgery date Peter MacCallum Cancer Centre, Australia All ADULT, OLDER_ADULT 3500 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00130 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; DRUG: ARV-471 + Abemaciclib; DRUG: Endoxifen + Abemaciclib; DRUG: Rilvegostomig + TDXd; DRUG: Dan222 + Niraparib; DRUG: Sarilumab + Cemiplimab + Paclitaxel 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., Post surgery based on upto 36-week treatment QuantumLeap Healthcare Collaborative All ADULT, OLDER_ADULT 5000 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 97517 03/01/2010 12/01/2030 12/01/2031 01/05/2010 22/10/2024 https://clinicaltrials.gov/study/NCT01042379 Localised/Locoregional Other N Y N United States Breast Any Breast Cancer Metformin Response rate Phase 1 DB00244 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], Toxicity-related discontinuation is defined as:for chemotherapy + losartan phase, discontinuation due to a treatment-related grade3 non-hematological adverse event; Toxicity assessments will be done using the NCI Common Terminology Criteria for Adverse Events v 5.0., 40 months; Number of participants discontinuing study treatment due to treatment related grade 3 adverse event [Toxicity], Toxicity-related discontinuation is defined as:for SBRT phase, discontinuation due to a grade3 Adverse Events (Enteritis, Gastritis, Malabsorption, Nausea) occurring for three consecutive days.Toxicity assessments will be done using the NCI Common Terminology Criteria for Adverse Events v 5.0., 40 months; Resectability rate, Rate of patients undergoing surgery on total patient population. Resectability will be determined by Multidisciplinary team according, 40 months Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori All ADULT, OLDER_ADULT 34 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRST157.04 14/06/2023 08/01/2026 08/01/2029 16/05/2023 01/05/2024 https://clinicaltrials.gov/study/NCT05861336 Localised/Locoregional Hospital/University/Research Institute N N N Italy GI Pancreatic Cancer Losartan Safety and/or Dose; Other (specify) Phase 2 DB00455 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, Using the surgery analysis set, the proportion of participants with R0 resection will be estimated with exact 95 confidence interval., Up to time of surgery OHSU Knight Cancer Institute All ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY00021614; NCI-2020-06277; STUDY00021614 27/05/2021 15/04/2025 10/05/2025 09/07/2020 11/06/2024 https://clinicaltrials.gov/study/NCT04539808 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Losartan Other (specify) Phase 2 DB00455 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), Defined from the date of study entry to the earliest date of progressive disease while receiving complete therapy with FOLFIRINOX-based therapy or death due to any cause. PFS will be censored at the date of last follow-up for patients alive without documented progression. PFS curves will be estimated by the Kaplan-Meier method and compared to historical controls treated with FOLFIRINOX alone using the one-sample log-rank test., Date of study entry to the earliest date of progressive disease up to 30 months Colin D. Weekes, M.D., PhD All ADULT, OLDER_ADULT 70 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 21-350 21/03/2022 31/12/2025 31/07/2026 14/10/2021 25/06/2024 https://clinicaltrials.gov/study/NCT05077800 Advanced/Metastatic Hospital/University/Research Institute Y Y N United States GI Pancreatic Cancer Losartan PFS Phase 2 DB00455 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, Will be graded according to Common Terminology Criteria for Adverse Events version (v) 5.0. The proportion of subjects that experience this endpoint will be tabulated along with an exact 90 binomial confidence interval (Clopper-Pearson)., Up to 3 months (84 days) after completion of radiation therapy University of Utah All ADULT, OLDER_ADULT 23 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT HCI121104; NCI-2019-05882; HCI121104; P30CA042014 08/08/2019 08/08/2025 08/08/2026 27/09/2019 29/05/2024 https://clinicaltrials.gov/study/NCT04106856 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Losartan Safety and/or Dose Phase 1 DB00455 N
NCT03900793 Losartan + Sunitinib in Treatment of Osteosarcoma RECRUITING Osteosarcoma DRUG: Losartan; DRUG: Sunitinib Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination, Assessment of Dose-Limiting Toxicities (DLTs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 to assess the safety of the combination, Beginning of study to end of study, up to 4 years; Maximally Tolerated Dose of Losartan and Sunitinib, The MTD will be defined as the dose level below that at which 1/3 or 2/6 patients experience DLTs., Beginning of study to end of study, up to 4 years; Recommended Phase 2 Dose of Losartan and Sunitinib, The dose that less that 33 of patients experience DLTs., Beginning of study to end of study, up to 4 years University of Colorado, Denver All CHILD, ADULT 41 OTHER Interventional Study Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 18-2740.cc; NCI-2019-06119 26/08/2019 08/01/2026 02/01/2027 04/03/2019 11/06/2024 https://clinicaltrials.gov/study/NCT03900793 Recurrent/Refractory Hospital/University/Research Institute N N N United States Bone Sarcoma Osteosarcoma Losartan Safety and/or Dose Phase 1 DB00455 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, The 28-week CR rates will be calculated in two arms, From date of recruitment until the date of CR, assessed up to 28 weeks. Xiaojun Chen Female ADULT 89 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 53211036-01 05/01/2022 28/02/2025 28/02/2026 04/07/2022 13/08/2024 https://clinicaltrials.gov/study/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 DB00358 N
NCT03024580 A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer MEGA UNKNOWN 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, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months, From date of randomization until disease progression or death due to any cause, assessed up to 18 months Instituto Nacional de Cancer, Brazil Female CHILD, ADULT, OLDER_ADULT 20 OTHER_GOV Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 64/16 03/06/2017 03/01/2020 09/01/2020 19/01/2017 15/08/2019 https://clinicaltrials.gov/study/NCT03024580 Advanced/Metastatic Hospital/University/Research Institute Y Y N Brazil Breast Breast Cancer - ER/HR+ Megestrol Acetate PFS Phase 2 DB00358 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, The cumulative 16-week CR rates will be calculated in two groups, From date of treatment initiation until the date of CR, assessed up to 16 weeks. Fudan University Female ADULT 104 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 53211032 03/11/2022 03/10/2025 03/10/2025 18/02/2022 26/09/2024 https://clinicaltrials.gov/study/NCT05247268 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate Phase 2 DB00358 N
NCT04046185 Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer ECCT UNKNOWN Endometrial Cancer Stage I DRUG: PD-1 inhibitor combined progesterone; DRUG: progesterone Pathologic complete remission rate of endometrial curettage tissues, Hysteroscopy was performed 6 months after treatment. If the pathological results are normal, it is considered to be complete remission, 6 months; Pathologic partial remission rate of endometrial curettage tissues, Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission, 6 months Shanghai First Maternity and Infant Hospital Female ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04046185 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate Phase 1 DB00358 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, From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks., 12 to 16 weeks Fudan University Female ADULT 48 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 53211029-02 09/01/2020 31/08/2025 31/08/2025 29/07/2020 29/01/2024 https://clinicaltrials.gov/study/NCT04491643 Localised/Locoregional Hospital/University/Research Institute N N N China Gynaecological Endometrial Cancer Megestrol Acetate; Rosuvastatin Response rate Phase 2 DB00358; DB01098 N
NCT05538897 Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers RECRUITING FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma|FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma|Metastatic Endometrial Endometrioid Adenocarcinoma|Recurrent Endometrial Endometrioid Adenocarcinoma PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; DRUG: Ipatasertib; PROCEDURE: Magnetic Resonance Imaging; DRUG: Megestrol Acetate Incidence of adverse events (AEs) (Phase Ib), To determine frequency and severity of adverse events for all dose combinations of megestrol acetate plus ipatasertib. Descriptive statistics will be used to summarize AEs. These analyses will focus on individuals who initiated their assigned treatment and will summarize maximum grade of AEs occurring during treatment classified by Common Toxicity Criteria (CTC) category. The primary summary of AEs will present counts and percentages, regardless of whether the AE was attributed to any of the study agents., Up to 5 years; Maximum tolerated dose for phase II (Phase Ib), Descriptive statistics will be used to summarize AEs. These analyses will focus on individuals who initiated their assigned treatment and will summarize maximum grade of AEs occurring during treatment classified by CTC category. The primary summary of AEs will present counts and percentages, regardless of whether the AE was attributed to any of the study agents., Up to 5 years; Progression free survival (PFS) (Phase II), Compare PFS of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with recurrent/metastatic endometrioid adenocarcinoma of the endometrium. A product-limit method will be used to estimate the cumulative distribution of PFS duration for each of the study treatments used in this population., From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years; Incidence of AEs (Phase II), Summarize the toxicity/adverse events of the combination of ipatasertib with megestrol acetate and megestrol acetate alone. Adverse events will be categorized using Common Terminology Criteria for Adverse Events version 5.0., Up to 5 years National Cancer Institute (NCI) Female ADULT, OLDER_ADULT 96 NIH Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NCI-2022-07505; NCI-2022-07505; NRG-GY028; NRG-GY028; U10CA180868 31/03/2023 31/01/2027 31/01/2027 14/09/2022 27/11/2024 https://clinicaltrials.gov/study/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 DB00358 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, Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100 , with higher values indicating higher proliferation. We will compare treatment-associated change in Ki-67 proliferation index between the 2 study arms, using a 1-sided test with significance at p \< 0.05. Ki-67 values will be assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following completion of treatment (post-treatment). Using a generalized estimating equation to take into account the repeated assessment of subjects (pre and post treatment), analysis will use a generalized linear regression model of Ki-67 index. Adjustment for potential confounding factors will be made as appropriate., Pre- and post-treatment up to 6 weeks City of Hope Medical Center Female ADULT, OLDER_ADULT 44 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 17327; NCI-2018-01555; 17327; P30CA033572 21/01/2019 11/07/2024 11/07/2024 14/09/2018 01/05/2024 https://clinicaltrials.gov/study/NCT03671811 Localised/Locoregional Hospital/University/Research Institute Y N N United States Gynaecological Endometrial Cancer Megestrol Acetate Biomarker Phase 2 DB00358 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, Recurrence-free survival, 3 years; MMRd-GREEN trial, Recurrence-free survival, 3 years; NSMP-ORANGE trial, Recurrence-free survival, 3 years; POLEmut-BLUE trial, Pelvic recurrence-free survival, 3 years Leiden University Medical Center Female ADULT, OLDER_ADULT 1615 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT05255653 Localised/Locoregional Hospital/University/Research Institute Y N N Netherlands Gynaecological Endometrial Cancer Megestrol Acetate DFS/RFS/EFS Phase 2/3 DB00358 N
NCT02506790 Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer UNKNOWN Breast Cancer DRUG: metformin; DRUG: Melatonin; DRUG: Toremifene Response rate, Response will evaluate by RECIST criteria, 4 months after FPFV; Pathomorphological response, Pathomorphological response will assess after surgery by Miller and Payne Scale, 4 months after FPFV N.N. Petrov National Medical Research Center of Oncology Female ADULT, OLDER_ADULT 96 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT MBC 2 07/01/2015 08/01/2020 08/01/2022 23/07/2015 09/04/2019 https://clinicaltrials.gov/study/NCT02506790 Localised/Locoregional Hospital/University/Research Institute N N N Russian Federation Breast Any Breast Cancer Melatonin; Metformin Response rate Phase 2 DB00351; DB00244 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)., Measured as relative risk (i.e., the incidence rate of metastasis in the Melatonin arm divided by the incidence rate in the control group), with 95 confidence interval., 5 years Gustav Stalhammar All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/NCT05502900 Adjuvant/Maintenance Localised/Locoregional Collaborative Group N N N Sweden Ocular Melanoma - Intraocular Melatonin OS; Recurrence rate Phase 3 DB00351 N
NCT04530097 Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC UNKNOWN NSCLC and Theropy PROCEDURE: RFA overall survival rate OS, From the beginning of randomization to the time of death due to any reason (patients who are lost to follow-up are the time of the last follow-up; patients who are still alive at the end of the study are the end of follow-up), when the survival curve reaches 2 years, the survival rate of patients., 2 years Shanghai 10th People's Hospital All ADULT, OLDER_ADULT 260 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04530097 Localised/Locoregional Hospital/University/Research Institute Y N N China Lung Non-Small Cell Lung Cancer Melatonin OS Other DB00351 N
NCT02506777 Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer. MBC1 UNKNOWN Breast Cancer DRUG: metformin; DRUG: Fluoruracil; DRUG: Doxorubicin; DRUG: Cyclophosphamide; DRUG: melatonin Response rate, Response will evaluate by RECIST criteria, 6 months after FPFV; Pathomorphological response, Pathomorphological response will assess after surgery by Miller and Payne Scale, 6 months after FPFV N.N. Petrov National Medical Research Center of Oncology Female ADULT, OLDER_ADULT 96 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT MBC1 07/01/2015 08/01/2020 08/01/2020 23/07/2015 09/04/2019 https://clinicaltrials.gov/study/NCT02506777 Localised/Locoregional Hospital/University/Research Institute Y Y N Russian Federation Breast Any Breast Cancer Melatonin; Metformin Response rate Phase 2 DB00351; DB00244 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, Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95 confidence intervals.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, Time Frame: 3 Years Ministry of Health, Saudi Arabia Female ADULT, OLDER_ADULT 200 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05680662 Localised/Locoregional; Advanced/Metastatic Local/National government Y N N Saudi Arabia Breast Any Breast Cancer Metformin DFS/RFS/EFS Phase 1 DB00244 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, While patients are on metformin therapy, time to treatment failure will be defined as one or all of the following criteria:1. ALC \> 5000 on 3 occasions after start of metformin treatment and increasing by 25 or more on each occasion, which will be measured every 3 months.2. An increase of Rai Stage (0-3) by one stage.3. An increase in any lymph node by \>50 as assessed by either physical exam (all patients) or CT scanning (only if ordered as part of routine clinical management).4. Worsening cytopenias (Hemoglobin \<11 g/dl) associated with a bone marrow biopsy result indicating advanced stage CLL (packed CLL marrow)., Until the patient meets failure criteria and stops Metformin; up to 6 months after start of metformin therapy and yearly thereafter. University of Michigan Rogel Cancer Center All ADULT, OLDER_ADULT 37 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT UMCC 2012.025 11/01/2012 12/01/2024 12/01/2024 17/12/2012 08/09/2024 https://clinicaltrials.gov/study/NCT01750567 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N United States Leukemia Chronic Lymphocytic Leukemia Metformin Biomarker; Other (specify) Phase 2 DB00244 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, Defined as a hypoglycemic event requiring permanent discontinuation of study treatment or any grade 3 or greater adverse event possibly, probably, or definitely related to the study drug., Up to 4-6 weeks; Change in pre-post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC), Generalized linear models will be used to assess differences between treatment arms for Ki67. Log transformation will be considered to obtain normal distribution of residuals. Will also evaluate the need to adjust for baseline characteristics and significant confounders (such as body mass index \[BMI\] and HER2 status)., Baseline up to 4-6 weeks; Difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms, Generalized linear models will be used to assess differences between treatment arms for Ki67. Log transformation will be considered to obtain normal distribution of residuals. Will also evaluate the need to adjust for baseline characteristics and significant confounders (such as BMI and HER2 status)., Post-treatment (4-6 weeks) M.D. Anderson Cancer Center Female ADULT, OLDER_ADULT 120 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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 21/06/2024 https://clinicaltrials.gov/study/NCT05023967 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Any Breast Cancer Metformin Safety and/or Dose; Biomarker Phase 2 DB00244 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, Proportion of patients who can obtain and maintain a ketogenic state (of 1.5 mmol/L or 27.0 mg/dL), Through study completion (an average of 8 months); Tolerability of metformin, Proportion of patients who can tolerate Metformin in the setting of the ketogenic diet (as assessed by standard CTC criteria), Through study completion (an average of 8 months) Weill Medical College of Cornell University All ADULT, OLDER_ADULT 36 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 1604017166 08/01/2016 12/01/2024 12/01/2024 31/12/2020 19/08/2024 https://clinicaltrials.gov/study/NCT04691960 Localised/Locoregional Hospital/University/Research Institute N N N Belgium CNS Medulloblastoma; Glioblastoma; Astrocytoma; Glioma Metformin Safety and/or Dose; Biomarker Phase 2 DB00244 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, In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted., Duration of phase I portion, approximately six months University of Louisville All ADULT, OLDER_ADULT 55 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT01638676 Advanced/Metastatic Hospital/University/Research Institute N N N United States Skin Melanoma Metformin Safety and/or Dose Phase 1/2 DB00244 N
NCT02823691 The MetNET-2 Trial MetNET-2 UNKNOWN Neuroendocrine Tumors DRUG: Lanreotide and Metformin incidence of SAEs and AEs, 1 year Fondazione IRCCS Istituto Nazionale dei Tumori, Milano All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NationalCIMilan 04/01/2016 12/01/2021 12/01/2021 07/06/2016 06/07/2021 https://clinicaltrials.gov/study/NCT02823691 Advanced/Metastatic Collaborative Group N N N Italy Endocrine Neuroendocrine Tumours Metformin Safety and/or Dose; Response rate; Biomarker; Other (specify) Phase 1 DB00244 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, Time from treatment start until documented disease progression (according to RECIST criteria) or death by any cause., 48 months Instituto Nacional de Cancerologia de Mexico All ADULT, OLDER_ADULT 312 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05445791 Advanced/Metastatic Hospital/University/Research Institute Y N N Mexico Lung Non-Small Cell Lung Cancer Metformin PFS Phase 3 DB00244 N
NCT03833466 Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo) ECMTPneo UNKNOWN Esophageal Squamous Cell Carcinoma DRUG: metformin and chemotherapy Tumor metabolic pathway, To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples, Through study completion, an average of 1 year; Tumor microenvironment, To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples, Through study completion, an average of 1 year Peking University All ADULT, OLDER_ADULT 15 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ESCC-MTPneo 02/05/2019 20/03/2020 20/06/2020 02/07/2019 15/02/2019 https://clinicaltrials.gov/study/NCT03833466 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Esophageal Cancer Metformin Response rate; Biomarker Phase 2 DB00244 N
NCT03600363 A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients UNKNOWN Lymphoma, Large B-Cell, Diffuse|Stage III Follicular Lymphoma DRUG: Metformin; DRUG: Placebos Overall Survival, From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months Ruijin Hospital All CHILD, ADULT, OLDER_ADULT 250 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00244 N
NCT05316935 GnRHa + Letrozole in Non-obese 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, The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment., From date of randomization until the date of CR, assessed up to 28 weeks Xiaojun Chen Female ADULT 80 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 53211030 13/07/2022 30/03/2025 30/03/2025 04/07/2022 08/01/2024 https://clinicaltrials.gov/study/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 DB00244 N
NCT01864096 The Metformin Active Surveillance Trial (MAST) Study MAST ACTIVE_NOT_RECRUITING Prostate Cancer DRUG: Metformin; DRUG: Placebo Time to progression, Time to progression - progression is defined as the earliest of the following events:1. Primary therapy for prostate cancer (e.g. prostatectomy, radiation, hormonal therapy)2. Pathological progression as defined as one of the following:i. \>1/3 of total amount of cores involved ii. At least 50 of any one core involved iii. Gleason pattern 4 or higher, 3 years University Health Network, Toronto Male ADULT, OLDER_ADULT 408 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT MAST 01 10/01/2013 16/02/2024 08/01/2024 29/05/2013 24/01/2024 https://clinicaltrials.gov/study/NCT01864096 Adjuvant/Maintenance Localised/Locoregional Collaborative Group Y N N Canada Urological Prostate Cancer Metformin Other (specify) Phase 3 DB00244 N
NCT03994744 Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC UNKNOWN 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), Assessing the response of treatment of each patient using RECIST 1.1 criteria, the investigators calculate the percentage of patients meet partial response (30 decrease in diameter) and complete response in the arm., 1 year; Safety of the combination therapy of Sintilimab and Metformin: CTCAE4.03 grading, Incidence and severity of (serious) adverse events in each individual according to the CTCAE4.03 grading., 2 year Hunan Cancer Hospital All ADULT, OLDER_ADULT 68 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT HNCH-SCLC-2019260 20/08/2019 08/01/2021 07/01/2022 21/06/2019 28/08/2019 https://clinicaltrials.gov/study/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 DB00244 N
NCT04414540 Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients ACTIVE_NOT_RECRUITING Head and Neck Squamous Cell Carcinoma DRUG: Metformin Extended Release Oral Tablet; DRUG: Pembrolizumab Overall Response by RECIST 1.1 and iRECIST, To determine anti-tumor activity by measuring overall response rate by RECIST 1.1 and iRECIST in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab., 2 years Trisha Wise-Draper All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT UCCC-HN-19-01 31/08/2020 07/01/2025 07/01/2025 06/04/2020 08/01/2024 https://clinicaltrials.gov/study/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 DB00244 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, Duration from randomization to time till development of CRPC (Castration-resistant prostate cancer). CRPC is defined by disease progression despite castration level of testosterone and may present as either a biochemical progression and/or radiological progression., 5 years Sun Yat-sen University Male ADULT, OLDER_ADULT 266 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2021-FXY-078 16/06/2021 30/04/2027 31/08/2027 14/06/2021 14/06/2021 https://clinicaltrials.gov/study/NCT04925063 Advanced/Metastatic Hospital/University/Research Institute Y N N China Urological Prostate Cancer Metformin PFS; OS Phase 2 DB00244 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, Measured by the occurrence of a progression event as per RANO criteria or death due to any cause prior to 6 months, At 6 months after the start of study treatment Weill Medical College of Cornell University All ADULT, OLDER_ADULT 33 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 21-05023537 14/02/2022 12/01/2024 12/01/2025 01/10/2022 19/08/2024 https://clinicaltrials.gov/study/NCT05183204 Localised/Locoregional Hospital/University/Research Institute N N N United States CNS Glioblastoma Metformin PFS; OS; Biomarker Phase 2 DB00244 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, The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria, Up to 2 years Fudan University Female ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT zsfud-OC-001 03/01/2023 02/01/2025 02/01/2025 03/08/2023 03/08/2023 https://clinicaltrials.gov/study/NCT05759312 Recurrent/Refractory Hospital/University/Research Institute N N N China Gynaecological Ovarian - Other Metformin Response rate Phase 1/2 DB00244 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, 28 days University of California, Davis Male ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 680462; UCDCC#243; UCDCC#243; P30CA093373; NCI-2014-02668 22/06/2016 04/01/2025 12/01/2025 15/01/2015 05/08/2024 https://clinicaltrials.gov/study/NCT02339168 Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Prostate Cancer Metformin Safety and/or Dose Phase 1 DB00244 N
NCT02437812 Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma UNKNOWN Epithelial Ovarian Carcinoma DRUG: Metformin; DRUG: Paclitaxel; DRUG: Carboplatin Progression free survival, The primary outcome of progression free survival will compare the percentage of those who have either progressed or died at 1 year with those who were at risk for at least 1 year., 5 years Gynecologic Oncology Associates Female ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GOA-TCOM1 01/01/2014 10/01/2017 04/01/2021 05/08/2015 28/02/2017 https://clinicaltrials.gov/study/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 DB00244 N
NCT05326984 Effect of Metformin on ABCB1 and AMPK Expression in Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia UNKNOWN Acute Lymphoblastic Leukemia DRUG: Metformin Decrease of ABCB1 gene expression, During the trial ABCB1 gene expression is measure by rt-PCR in mononuclear cells in peripheral blood, at at the beginning of treatment and end of the remission induction, The assessment of ABCB1 gene expression will be made at diagnosis (day -7) and at the end of remission induction phase on day +33; Increase of AMPK gene expression, During the trial AMPK gene expression is measure by rt-PCR in mononuclear cells in peripheral blood, at athe beginning and end of the remission induction., The assessment of AMPK gene expression will be made at diagnosis (day -7) and at the end of remission induction phase on day +33 Hospital General de Mexico All CHILD, ADULT 20 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/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 DB00244 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., * A hypoxia related 6-gene expression signature analyzed by RNA-sequencing will be obtained before and after one week of metformin* The signature consist of the following six genes: ERO1A, DDIT3, KCTD11, P4HA2, STC2, UPK1A, baseline and one week Oslo University Hospital Female ADULT, OLDER_ADULT 90 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT METOXY-LACC 22/05/2020 05/01/2025 09/01/2025 19/02/2020 05/03/2022 https://clinicaltrials.gov/study/NCT04275713 Localised/Locoregional Hospital/University/Research Institute Y N N Norway Gynaecological Cervical Cancer Metformin Biomarker Phase 2 DB00244 N
NCT02294006 Activity and Safety of Everolimus+Octreotide LAR+Metformin in Advanced Pancreatic Well-differentiated NETs MetNET1 UNKNOWN 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, progression free survival rate at 12th month of treatment, according to RECIST criteria version 1.0, 1 year Fondazione IRCCS Istituto Nazionale dei Tumori, Milano All ADULT, OLDER_ADULT 26 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT02294006 Advanced/Metastatic Hospital/University/Research Institute N N N Italy Endocrine Neuroendocrine Tumours Metformin Safety and/or Dose; PFS Phase 2 DB00244 N
NCT03238495 Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer HERMET UNKNOWN HER2-positive Breast Cancer DRUG: Taxotere, Carboplatin, Herceptin + Pertuzumab; DRUG: Metformin Pathologic complete response (pCR), pCR at surgery, Up to 6 weeks after last chemotherapy treatment Qamar Khan Female ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00140673 15/08/2017 06/01/2022 06/01/2023 08/03/2017 12/07/2021 https://clinicaltrials.gov/study/NCT03238495 Localised/Locoregional Hospital/University/Research Institute Y N N United States Breast Breast Cancer - HER2+ Metformin Response rate Phase 2 DB00244 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), Clinical benefit rate (CBR) determined by combining the complete response rate, partial response rate, and stable disease rate. Response evaluated by repeat imaging (CT or MRI) using RECIST 1.1 at the completion of the second cycle (8 weeks + 7 days of treatment)., 8 weeks M.D. Anderson Cancer Center All ADULT, OLDER_ADULT 62 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2012-0543; NCI-2013-00960 10/07/2013 31/10/2025 31/10/2025 22/02/2013 24/10/2024 https://clinicaltrials.gov/study/NCT01797523 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Endometrial Cancer Metformin PFS; Other (specify) Phase 2 DB00244 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, determine the cell cycle status, up to 4 years Yana Najjar All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 16-196 02/07/2018 01/01/2027 12/01/2028 17/10/2017 05/07/2024 https://clinicaltrials.gov/study/NCT03311308 Localised/Locoregional; Advanced/Metastatic Company Y N N China Skin Melanoma Metformin Safety and/or Dose; Biomarker Phase 1 DB00244 N
NCT04559308 The Effect of Metformin on Breast Cancer Patients UNKNOWN Breast Cancer DRUG: Metformin; DRUG: Chemotherapy Clinical benefit rate (Tumor size), Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy., 8 months Beni-Suef University Female ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT BSU 06/01/2019 15/09/2020 10/01/2020 22/09/2020 22/09/2020 https://clinicaltrials.gov/study/NCT04559308 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Metformin Response rate Phase 2 DB00244 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, It allow us to determine the efficacy at the recommended dose (RD) of metformin in patients with GBM, Frome baseline to 6 months University of Milano Bicocca All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT GBM MET 12/01/2023 01/01/2026 01/01/2026 07/03/2023 11/09/2023 https://clinicaltrials.gov/study/NCT05929495 Localised/Locoregional Hospital/University/Research Institute N N N Italy CNS Glioblastoma Metformin Safety and/or Dose; PFS; QoL; Biomarker Phase 2 DB00244 N
NCT04926155 The Effect of Metformin in Patients With Metastatic Castration-resistant Prostate Cancer UNKNOWN Metastatic Prostate Cancer DRUG: Metformin Progression-free survival defined from randomization to time till biochemical progression or radiographic progression, start of treatment to disease progression, up to 36 months Sun Yat-sen University Male ADULT, OLDER_ADULT 234 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 2021-FXY-072 23/06/2021 30/04/2024 31/08/2024 14/06/2021 14/06/2021 https://clinicaltrials.gov/study/NCT04926155 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute Y N N China Urological Prostate Cancer Metformin PFS; OS Phase 2 DB00244 N
NCT02122185 Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ACTIVE_NOT_RECRUITING 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, Kaplan-Meier curves will be generated and the metformin and placebo groups compared using a logrank test stratified by initial treatment (primary debulking surgery or neoadjuvant therapy). A one-sided alpha level of 0.15 will be used to determine statistical significance. Median PFS and associated 90 confidence interval will be estimated using the method described in Brookmeyer and Crowley. A Cox regression model will also be fit to assess and adjust for the effects of the stratification factor and other baseline covariates (for example, age, ECOG performance status)., Time from randomization until disease progression or death from any cause, assessed up to 2 years University of Chicago Female ADULT, OLDER_ADULT 110 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT IRB13-1235; NCI-2014-00860; IRB13-1235 25/02/2015 25/02/2025 25/02/2025 24/04/2014 31/07/2024 https://clinicaltrials.gov/study/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 DB00244 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 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, Anti-tumor activity will be assessed by ORR (defined as the sum of Complete Responses (CR) and/or Partial Responses (PR)) as measured by CT or MRI scan approximately every 8 weeks and assessed by Response Evaluation Criteria in Solid Tumors, RECIST criteria v1.1 using the patients best response to treatment where:CR=Disappearance of all lesions PR=At least a 30 decrease in the sum of the diameters of the target lesions, taking as reference the baseline sum diameters, up to a maximum of 24 weeks from start of treatment (Range of cycles that best response was seen was 2-5 cycles of treatment where 1 cycle =28 days) Northwestern University All ADULT, OLDER_ADULT 17 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NU 16L04; STU00204354; NU 16L04; 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/study/NCT03048500 Advanced/Metastatic Hospital/University/Research Institute N N N United States Lung Non-Small Cell Lung Cancer Metformin Response rate; PFS Phase 2 DB00244 N
NCT03874000 Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients SMART UNKNOWN Non Small Cell Lung Cancer BIOLOGICAL: Sintilimab; DRUG: Metformin Hydrochloride Objective Response Rate (ORR), ORR is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients., each 42 days up to intolerance the toxicity or PD (up to 24 months) Tianjin Medical University Cancer Institute and Hospital All ADULT, OLDER_ADULT 43 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT SMART 03/08/2019 28/02/2022 06/05/2022 14/03/2019 19/03/2019 https://clinicaltrials.gov/study/NCT03874000 Recurrent/Refractory Hospital/University/Research Institute N N N China Lung Non-Small Cell Lung Cancer Metformin Response rate; PFS; OS Phase 2 DB00244 N
NCT03047837 A Randomized, 2x2 Factorial Design Biomarker Prevention Trial of Low-dose ASA and Metformin in Stage I-III Crc Patients ASAMET ACTIVE_NOT_RECRUITING Tertiary Prevention in Colon Cancer DRUG: ASA; DRUG: MET; OTHER: Placebo NF B, It will be measured the change, defined as the difference between post- and pre-treatment levels, in NF B expression in normal colonic tissue. The NF B transcription factor family is composed of the p65, RelB, c-Rel, p105, andt p100 subunits, and activation of the NF B pathway is defined by the nuclear translocation of the p65 subunit. Therefore, cytoplasmic and nuclear localization of p65 will be immunohistochemically assessed as an indicator of NF B activity. The analysis of expression will be performed by semi quantitative assessment: NF B expression will be measured primarily as the percentage of positive nuclear areas for NFkB over the total nuclear areas in 10 section fields., 1 year Ente Ospedaliero Ospedali Galliera All ADULT, OLDER_ADULT 160 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION 27UCS2015; 2015-004824-77 15/03/2017 31/03/2024 31/03/2024 02/09/2017 21/02/2024 https://clinicaltrials.gov/study/NCT03047837 Localised/Locoregional Hospital/University/Research Institute Y N N Italy GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid; Metformin Biomarker Phase 2 DB00945; DB00244 N
NCT01930864 Metformin Plus Irinotecan for Refractory Colorectal Cancer UNKNOWN Colorectal Neoplasms|Adenocarcinoma DRUG: metformin; DRUG: irinotecan Non-Progression at week 12th of treatment, Non-Progression at week 12th of treatment, 12th week Barretos Cancer Hospital All ADULT, OLDER_ADULT 41 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MetIri 09/01/2015 12/01/2020 12/01/2020 29/08/2013 22/06/2017 https://clinicaltrials.gov/study/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 DB00244 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, Evaluate the event free survival (EFS) in osteosarcoma and Ewing sarcoma patients with high risk of relapse compared to the historical control, 3 years Istituto Ortopedico Rizzoli All CHILD, ADULT, OLDER_ADULT 67 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|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/study/NCT04758000 Localised/Locoregional Hospital/University/Research Institute N N N Italy Bone Sarcoma Ewing Sarcoma; Osteosarcoma Metformin DFS/RFS/EFS Phase 2 DB00244 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, 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., 3 months Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) All ADULT, OLDER_ADULT 49 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT Medonc-17-11 09/01/2019 31/07/2024 10/01/2029 20/12/2017 21/09/2023 https://clinicaltrials.gov/study/NCT03379909 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands Urological Bladder Cancer Metformin Response rate Phase 2 DB00244 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 determine overall survival, At one year McGill University Health Centre/Research Institute of the McGill University Health Centre All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MUHC ID: 4315 03/01/2015 20/10/2021 28/02/2026 23/05/2016 24/10/2023 https://clinicaltrials.gov/study/NCT02780024 Localised/Locoregional Hospital/University/Research Institute N N N Canada CNS Glioblastoma Metformin Safety and/or Dose; Other (specify) Phase 2 DB00244 N
NCT02065687 Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer UNKNOWN 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), Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years; Overall Survival (OS) (Phase II and III), The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of death or the date of last contact, assessed up to 5 years Gynecologic Oncology Group Female ADULT, OLDER_ADULT 469 NETWORK Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT GOG-0286B; NCI-2013-02284; s14-01068; GOG-0286B; GOG-0286B; GOG-0286B; U10CA180830; U10CA180868; U10CA027469 17/03/2014 17/04/2019 13/09/2023 19/02/2014 01/12/2021 30/09/2021 https://clinicaltrials.gov/study/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 DB00244 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, MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33 . DLTs defined as adverse events (AEs) related to study agents which occur during first cycle of treatment. Toxicity must have possible, probable or definite attribution to study drugs., 10 weeks M.D. Anderson Cancer Center All CHILD, ADULT, OLDER_ADULT 87 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2011-0923; NCI-2012-00216 26/03/2012 06/01/2026 06/01/2026 02/09/2012 11/07/2024 https://clinicaltrials.gov/study/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 DB00244 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, Defined as time from first dose of treatment to death from any cause, or even radiological detection/or clinical of disease progression., up to 12 weeks Zhongnan Hospital All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ZNCM 07/01/2020 12/01/2024 12/01/2024 25/07/2019 28/09/2023 https://clinicaltrials.gov/study/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 DB00126; DB00244 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, Feasibility is defined at 1 or fewer patients experiencing a dose limiting toxicity within the first 6 patients., Up to 24 months; 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), The percent of patients who are fully compliant in the first week will be estimated with a 95 confidence interval. The compliance will be measured similarly for each course prior to study treatment discontinuation. The impact of less than full compliance (both during the lead-in period and during chemotherapy) on the biomarkers and outcome, and qualitatively study patient reasons and specific supplement patterns related to non-compliance will be explored., Up to 24 months; 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), Summarized using the National Cancer Institute Common Terminology for Adverse Events criteria version 4. Tables will summarize the highest grade per patient that is possibly related to treatment, and the number of patients requiring dose modifications will also be presented., Up to 24 months City of Hope Medical Center All ADULT, OLDER_ADULT 21 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 14122; NCI-2014-02612; 14122 14/01/2016 10/04/2020 31/12/2024 01/12/2015 19/03/2024 https://clinicaltrials.gov/study/NCT02336087 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Metformin Other (specify) Phase 1 DB00244 N
NCT04536805 Relapse in Previously Irradiated Prostate Bed : Stereotactic Ablative Reirradiation Potentiated by Metformin REPAIR 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, SBRT toxicity will be reported during the 12 weeks following the initiation of SBRT., 12 weeks; For phase 2: estimate the efficacy of re-irradiation SBRT in combination with Metformin in terms of biochemical relapse-free survival rate., PSA levels will be assessed every 3 months within 3 years after SBRT., 3 years Institut Cancerologie de l'Ouest Male ADULT, OLDER_ADULT 44 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT ICO-2020-01 17/11/2020 11/01/2028 11/01/2030 09/03/2020 13/03/2024 https://clinicaltrials.gov/study/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 DB00244 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, Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent ( ) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR., From Cycle 1 Day 1 up to 6 years 2 months; Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib, Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose; Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib, Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib, Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib, Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days); Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib, Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); 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, Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib, Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib, Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days); 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, AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); 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, AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); 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, AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of metformin alone or in combination with erdafitinib., Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days); 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, AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of midazolam alone or in combination with erdafitinib., Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days); Drug-Drug Interaction (DDI Janssen Research Development, LLC All ADULT, OLDER_ADULT 239 INDUSTRY Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CR105065; 42756493BLC2001; 2014-002408-26; 2023-510273-34-00 22/04/2015 15/09/2022 31/12/2024 19/02/2015 10/10/2023 10/10/2024 https://clinicaltrials.gov/study/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 DB00244; DB01110 N
NCT03675893 RESOLVE: Abemaciclib + Letrozole +/- Metformin or Zotatifin in Endometrial or Low-Grade Serous Ovarian Cancer ACTIVE_NOT_RECRUITING Endometrial Cancer|Ovarian Cancer DRUG: Letrozole; DRUG: Abemaciclib; DRUG: LY3023414; DRUG: Metformin; DRUG: Zotatifin Progression Free Survival Rate, Number of patients alive and disease progression-free per RECIST 1.1 criteria., 6 months; Objective Tumor Response Rate, Number of patients who experience objective tumor responses per RECIST 1.1 criteria., 6 months Dana-Farber Cancer Institute Female ADULT, OLDER_ADULT 130 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 18-301 24/12/2018 08/01/2027 08/01/2030 18/09/2018 11/07/2024 https://clinicaltrials.gov/study/NCT03675893 Recurrent/Refractory Hospital/University/Research Institute N N N United States Gynaecological Endometrial Cancer Metformin Response rate; PFS Phase 2 DB00244 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), Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \[1\] At least a 20 increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of 1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported., From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. NRG Oncology All ADULT, OLDER_ADULT 170 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT NRG-LU001; NCI-2014-01071; PNRG-LU001_A01PAMDREVW01; NRG-LU001; NRG-LU001; U10CA180868 08/01/2014 16/04/2019 16/04/2025 07/10/2014 23/06/2020 30/05/2024 https://clinicaltrials.gov/study/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 DB00244 N
NCT02978547 The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma Metformin 001 UNKNOWN Resectable Pancreatic Ductal Adenocarcinoma DRUG: Metformin Hydrochloride 500Mg Tablet The effect of neoadjuvant metformin treatment on tumour cell proliferation in PDAC tumours, Assessment of Ki-67 fraction as assessed by IHC of pre- and post-metformin tumour samples., 6 months British Columbia Cancer Agency All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT H16-02566 01/01/2019 06/01/2020 01/01/2021 12/01/2016 18/01/2018 https://clinicaltrials.gov/study/NCT02978547 Localised/Locoregional Collaborative Group N N N Canada GI Pancreatic Cancer Metformin Biomarker; Other (specify) Phase 2 DB00244 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, Rate of pathologic complete responses (pCRs), 36 months Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Female ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|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/study/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 DB00244 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, The time from the initial surgical treatment of colorectal cancer to the earliest evidence of recurrence., 5 years Shanghai Jiao Tong University School of Medicine All ADULT, OLDER_ADULT 294 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB01233 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, The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention., Up to approximately 3 years; Overall Survival (OS), OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time., Up to approximately 3 years Liaoning Tumor Hospital Institute All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 20230201zzg 03/01/2023 03/01/2026 09/01/2026 02/09/2023 02/09/2023 https://clinicaltrials.gov/study/NCT05720559 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Colon Cancer; Rectal Cancer Metronidazole OS; Other (specify) Phase 2 DB01233 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 response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1, Up to approximately 2 years; Overall Survival (OS), OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time, Up to approximately 2 years; Progression Free Survival (PFS), PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause., Up to approximately 2 years Liaoning Tumor Hospital Institute All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 20230303zzg 15/03/2023 15/03/2025 15/03/2025 20/03/2023 20/03/2023 https://clinicaltrials.gov/study/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 DB01233 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), Measured using the RECIST guideline v1.1, 12 months University of Chicago All ADULT, OLDER_ADULT 29 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT IRB16-0403 28/03/2017 21/12/2022 08/01/2024 06/02/2016 16/02/2024 16/02/2024 https://clinicaltrials.gov/study/NCT02788981 Advanced/Metastatic Hospital/University/Research Institute Y N N United States Breast Breast Cancer - TNBC Miltefosine Response rate; PFS; OS; Biomarker Phase 2 DB00834 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), Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Committee (version 1.1)., 2 years Memorial Sloan Kettering Cancer Center All ADULT, OLDER_ADULT 201 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT 22-334 18/10/2023 10/01/2027 10/01/2027 25/10/2023 11/04/2024 https://clinicaltrials.gov/study/NCT06099769 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Breast Breast Cancer - TNBC Mifepristone PFS Phase 2 DB00683 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, Determine the overall response rate (ORR) based on RECIST 1.1 of the combination of pembrolizumab and mifepristone in the different subtypes of breast cancer (hormone receptor positive and triple-negative), From the time of first documented complete response or appearance of one or more new lesions, until the first documented date of recurrent or progressive disease, whichever came first, assessed up to 100 months. University of Chicago All ADULT, OLDER_ADULT 74 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT IRB17-0721 02/12/2018 09/01/2025 09/01/2025 21/07/2017 31/07/2024 https://clinicaltrials.gov/study/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 DB00683 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, Improvement in 3 year disease free survival by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy)., 3 years Tata Memorial Hospital Female ADULT, OLDER_ADULT 348 OTHER_GOV Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT TMH Project 1543 16/01/2018 30/09/2025 30/09/2025 22/08/2017 04/11/2024 https://clinicaltrials.gov/study/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 DB00788 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, Response will be defined by RECIST 1.1 as defined by Prostate Cancer Clinical Trials Working Group 3 definition for complete response (CR) - disappearance of all target lesions); partial response (PR) (at least a 30 decrease in the sum of diameters of target lesions); progressive disease (PD) (at least a 20 increase in the sum of diameters or target lesions); stable disease (SD) (neither sufficient shrinkage to qualify for partial response nor sufficient to qualify for progressive disease); or not evaluable (NE)., At 3, 6 and 9 months; Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3), Response will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) or not evaluable (NE)., At 3, 6 and 9 months Wake Forest University Health Sciences Male ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRB00068039; P30CA012197; WFBCC 85220 03/05/2021 01/01/2025 04/01/2026 04/07/2020 19/09/2024 https://clinicaltrials.gov/study/NCT04337580 Recurrent/Refractory Hospital/University/Research Institute N N N United States Urological Prostate Cancer Omeprazole QoL; Biomarker Phase 2 DB13961 N
NCT02950259 Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) ACTIVE_NOT_RECRUITING Breast Neoplasm|Breast Neoplasm, Male|Triple Negative Breast Cancer DRUG: Cyclophosphamide; DRUG: Indomethacin; DRUG: Omeprazole; DIETARY_SUPPLEMENT: Multivitamin Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients, The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen., Day 1 to Day 26 Providence Health Services All CHILD, ADULT, OLDER_ADULT 16 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT 16-126B; IRX-2 2016-B 02/09/2017 13/05/2019 12/01/2024 11/01/2016 30/01/2024 21/08/2024 https://clinicaltrials.gov/study/NCT02950259 Localised/Locoregional Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Indomethacin; Omeprazole Safety and/or Dose Phase 1 DB00224; DB13961 N
NCT06176339 Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients ACTIVE_NOT_RECRUITING Breast Cancer Female DRUG: Pentoxifylline Oral Tablet; DRUG: Placebo Relative reduction in tumor size after neoadjuvant chemotherapy treatment, Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles., 6 months Mansoura University All ADULT, OLDER_ADULT 70 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT 2023-147-1 15/12/2023 30/08/2024 30/09/2024 19/12/2023 15/03/2024 https://clinicaltrials.gov/study/NCT06176339 Localised/Locoregional Hospital/University/Research Institute Y N N Egypt Breast Any Breast Cancer Pentoxifylline Safety and/or Dose; Other (specify) Phase 2 DB00738 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, 36 months-end of trial University of Louisville All ADULT, OLDER_ADULT 59 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT BCC-RAD-13-Pentoxifylline 10/01/2013 12/01/2025 12/01/2025 06/06/2013 02/07/2024 https://clinicaltrials.gov/study/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 DB00738 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), 3 samples of peripheral venous blood will be obtained from the patients from both study groups before the beginning of treatment (day 0), at the end of the first cycle of chemotherapy (day 30), and the end of the second cycle (day 60). Fortilin plasma levels will be determined using the translationally controlled human tumor protein ELISA kit (TPT1), according to the manufacturer's specifications. The optical density will be determined using a Biotek Synergy HT plate reader at a wavelength of 450nm. The results will be presented as the mean standard deviation in pg/mL.In the 3 blood samples that will be taken from the participants, the same marker will be evaluated. As it is the same variable, it will be measured with the same unit of measure (pg/mL) for the 3 blood samples.At the end of the study, it will be evaluated if there was any change in the plasma levels of fortilin (in pg/mL), either an increase or a decrease., At the end of the second cycle of chemotherapy (day 60 after starting chemotherapy, since each cycle of treatment is 30 days); Peripheral apoptosis (Cytochrome c), 3 samples of peripheral venous blood will be obtained from the patients from both study groups before the beginning of treatment (day 0), at the end of the first cycle of chemotherapy (day 30), and the end of the second cycle (day 60). Cytochrome c plasma levels will be determined using the human cytochrome c ELISA kit, according to the manufacturer's specifications. The optical density will be determined using a Biotek Synergy HT plate reader at a wavelength of 450nm. The results will be presented as the mean standard deviation in pg/mL.In the 3 blood samples that will be taken from the participants, the same marker will be evaluated. As it is the same variable, it will be measured with the same unit of measure (pg/mL) for the 3 blood samples.At the end of the study, it will be evaluated if there was any change in the plasma levels of fortilin (in pg/mL), either an increase or a decrease., At the end of the second cycle of chemotherapy (day 60 after starting chemotherapy, since each cycle of treatment is 30 days) University of Guadalajara All CHILD, ADULT 30 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/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 DB00738 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, The primary activity endpoint is the number of responders. Patients will be considered as responders if they reach a CR or PR as best response during treatment according to RECIST criteria or according to Choi criteria., From the date of the enrollment up to 24 months Mario Negri Institute for Pharmacological Research All ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRFMN-SARCO-7953 02/02/2022 12/02/2024 02/02/2025 03/11/2021 13/03/2024 https://clinicaltrials.gov/study/NCT04794127 Localised/Locoregional; Recurrent/Refractory Hospital/University/Research Institute N N N Italy Soft Tissue Sarcoma Liposarcoma Pioglitazone Response rate Phase 2 DB01100 N
NCT02889003 Second STOP After Pioglitazone Priming in CML Patients PIO2STOP UNKNOWN Chronic Myeloid Leukemia (CML) DRUG: Pioglitazone + TKI Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Up to 24 months after inclusion; Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation., Up to 24 months after inclusion Versailles Hospital All ADULT, OLDER_ADULT 26 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT P16/05_PIO2STOP 12/01/2016 12/01/2021 12/01/2021 09/05/2016 22/03/2018 https://clinicaltrials.gov/study/NCT02889003 Localised/Locoregional Hospital/University/Research Institute N N N France Leukemia Chronic Myelogenous Leukemia Pioglitazone Safety and/or Dose; Other (specify) Phase 2 DB01100 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; DRUG: BGB-11417; DRUG: BGB-11417 Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs), Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs); Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Approximately 24 months; Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate, CR plus CRh will be defined as the percentage of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment., Approximately 24 months; Part 3 MDS Cohort: Modified Overall Response (mOR) Rate, The mOR will be defined as the percentage of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic/myeloproliferative neoplasm (MDS/MPN)., Approximately 24 months; Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole, Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose); Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole, Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose); 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 Administered Alone and When Co-administered With Posaconazole, Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose); Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs, Cycle 2; Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs, Approximately 24 months BeiGene All ADULT, OLDER_ADULT 260 INDUSTRY Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT BGB-11417-103; 2021-003285-12; 2023-508881-14-00 24/05/2021 02/08/2028 02/08/2028 25/02/2021 29/10/2024 https://clinicaltrials.gov/study/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 DB01263 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 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), The QoR-40 consists of a total of 40 questionnaires divided into five categories, it is considered to be the most appropriate index to measure the patient's integrated post operation recovery. Our primary outcome is the score of QoR-40 on the third day after surgery, post operative day #3 Yonsei University All ADULT, OLDER_ADULT 132 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT03447691 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Pancreatic Cancer; Cholangiocaricnoma Propofol Other (specify) Other DB00818 N
NCT04503148 Anesthesia and Cancer Study: Renal Cell Carcinoma ACTIVE_NOT_RECRUITING Renal Cell Carcinoma DRUG: Propofol; DRUG: Inhaled General Anesthetics five year metastasis-free survival, five year metastasis-free survival, five year after surgery Seoul National University Hospital All ADULT, OLDER_ADULT 562 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION Ane-Can Nx 22/09/2020 22/12/2022 22/12/2025 08/07/2020 23/07/2024 https://clinicaltrials.gov/study/NCT04503148 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of Urological Renal Cell Carcinoma Propofol OS; Other (specify) Other DB00818 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, progression-free survival, 5 years Kaohsiung Medical University Chung-Ho Memorial Hospital Female ADULT, OLDER_ADULT 416 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05606692 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan Gynaecological Ovarian Epithelial Cancer Propofol PFS Phase 4 DB00818 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, Time to event, 2 year minimum Stony Brook University All ADULT, OLDER_ADULT 1804 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT 967670-3 31/01/2017 09/01/2024 12/01/2024 27/01/2017 13/03/2024 https://clinicaltrials.gov/study/NCT03034096 Localised/Locoregional Hospital/University/Research Institute Y N N United States Multiple cancer types Multiple cancer types Propofol DFS/RFS/EFS Phase 4 DB00818 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, Feasibility outcomes: successful recruitment of trial participants, 6 months; retention rate, Feasibility outcomes: successful retention of trial participants, 6 months; rate of protocol adherence, Feasibility outcomes: successful intervention fidelity, identification of barriers to implementation of the intervention, and the feasibility of collecting outcome assessment data., 6 months University Health Network, Toronto All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE 21-5527.0 01/01/2022 12/01/2024 30/06/2025 15/07/2021 05/08/2024 https://clinicaltrials.gov/study/NCT04962672 Localised/Locoregional Hospital/University/Research Institute Y N N Canada CNS Glioblastoma Propofol PFS; OS; Other (specify) Other DB00818 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, The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia., Post-operative day (POD) 1 to POD 6 months University of Kansas Medical Center All ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT STUDY00149314; NCI-2023-05587; IIT-2022-VIVA; STUDY00149314; P30CA168524 22/05/2023 22/05/2025 22/05/2026 30/08/2023 30/08/2023 https://clinicaltrials.gov/study/NCT06017141 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Colon Cancer Propofol OS; Recurrence rate; Biomarker Phase 2 DB00818 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, Patients who did not experience cancer recurrence and/or death., 4 years The Cleveland Clinic All ADULT, OLDER_ADULT 1614 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04513808 Localised/Locoregional Hospital/University/Research Institute Y N N United States Multiple cancer types Any solid tumours Propofol DFS/RFS/EFS Phase 3 DB00818 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, 6-month overall survival, 1-year overall survival, and 3-year overall survival, From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months; The presence of disease progression, From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months, From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months Kaohsiung Medical University Chung-Ho Memorial Hospital All ADULT, OLDER_ADULT 300 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05663242 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan Lung Any lung cancers Propofol PFS; OS Phase 4 DB00818 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, 6-month overall survival, 1-year overall survival, and 3-year overall survival, From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months; The presence of disease progression, From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months, From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months Kaohsiung Medical University Chung-Ho Memorial Hospital All ADULT, OLDER_ADULT 1316 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05926336 Localised/Locoregional Hospital/University/Research Institute N N N Taiwan Multiple cancer types Multiple cancer types Propofol OS; Other (specify) Phase 4 DB00818 N
NCT04259398 Anesthesia and Cancer Study: Colon Cancer ACTIVE_NOT_RECRUITING Cancer of Colon|Anesthesia DRUG: Propofol; DRUG: Sevoflurane five year survival, survival rate regardless of recurrence, five years survival Seoul National University Hospital All ADULT, OLDER_ADULT 797 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04259398 Localised/Locoregional Hospital/University/Research Institute Y N N Korea, Republic of GI Colon Cancer Propofol DFS/RFS/EFS Other DB00818 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, the detection of a two-fold difference between the pre-operative blood sample and 24-hour post-operative blood sample in HIF-1 gene expression in the SEVO group, and a less than two-fold difference in the same samples of the TIVA group, 24 hour The University of Hong Kong All ADULT, OLDER_ADULT 220 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04601961 Localised/Locoregional Hospital/University/Research Institute Y N N China GI Liver Cancer Propofol Recurrence rate; Biomarker Other DB00818 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, 6-month overall survival, 1-year overall survival, and 3-year overall survival, From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ; The presence of disease progression, From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months , From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months Kaohsiung Medical University Chung-Ho Memorial Hospital All ADULT, OLDER_ADULT 500 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05331911 Localised/Locoregional Hospital/University/Research Institute Y N N Taiwan GI Liver Cancer Propofol PFS; OS; Other (specify) Phase 4 DB00818 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, Absolute number of neutrophils divided by the absolute number of lymphocytes, 1 hour after surgery; Neutrophil-lymphocyte ratio, Absolute number of neutrophils divided by the absolute number of lymphocytes, 24 hours after surgery Moscow Clinical Scientific Center Female ADULT, OLDER_ADULT 130 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04800393 Localised/Locoregional Hospital/University/Research Institute Y N N Russian Federation Breast Any Breast Cancer Propofol Biomarker Other DB00818 N
NCT05141877 Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor anesthetics RECRUITING Brain Tumor DRUG: Propofol; DRUG: Sevoflurane Overall survival, 6-month overall survival, 6-month; Overall survival, 1-year overall survival, 1-year; Overall survival, 3-year overall survival, 3-year Kaohsiung Medical University Chung-Ho Memorial Hospital All ADULT, OLDER_ADULT 706 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT05141877 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Other multiple cancer group (specify) Propofol PFS; OS Phase 4 DB00818 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, pg/mL, intraoperative to postoperative 24 hours Hong Kong Children's Hospital All CHILD, ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04475705 Localised/Locoregional Hospital/University/Research Institute Y N Y Hong Kong Multiple cancer types Any solid tumours Propofol Biomarker Phase 4 DB00818 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), Efficacy of pembrolizumab in combination with propranolol with standard chemotherapy measured by ORR by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, which is treated as a dichotomous variable and will be summarized using frequencies and relative frequencies., Within 6 months of initiating combination therapy Roswell Park Cancer Institute All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT I 2734222; NCI-2022-09209; I 2734222; W81XWH2210916 03/07/2023 30/03/2026 30/03/2026 15/12/2022 14/06/2024 https://clinicaltrials.gov/study/NCT05651594 Localised/Locoregional; Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Esophageal Cancer Propranolol Response rate Phase 2 DB00571 N
NCT04493489 Propranolol Adjuvant Treatment of Bladder Cancer UNKNOWN Bladder Cancer DRUG: Propranolol Hydrochloride; DRUG: BCG two-year recurrence-free survival, 24 months Central South University All ADULT, OLDER_ADULT 242 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT04493489 Localised/Locoregional Hospital/University/Research Institute Y N N China Urological Bladder Cancer Propranolol DFS/RFS/EFS Phase 2 DB00571 N
NCT05797662 A Study of Propranolol to Treat Kaposi Sarcoma NOT_YET_RECRUITING Kaposi Sarcoma DRUG: Propranolol Objective Response Rate, ORR is defined as the proportion of participants with complete response (CR), or partial response (PR) based on AIDS Malignancy Consortium Kaposi Sarcoma (AMC KS) Response Criteria., At one year AIDS Malignancy Consortium All CHILD, ADULT, OLDER_ADULT 25 NETWORK Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT AMC-116; UM1CA121947 07/01/2025 08/01/2028 08/01/2029 04/04/2023 28/02/2024 https://clinicaltrials.gov/study/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 DB00571 N
NCT02897986 Study of a Propranolol (HEMANGIOL ) and Oral Metronomic Vinorelbine (NAVELBINE ) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors PROVIN UNKNOWN Pediatric Cancer DRUG: administration of a propranolol (HEMANGIOL ) and oral metronomic vinorelbine (NAVELBINE ) combination number of patients with grade 3 toxicity, 28 days Assistance Publique Hopitaux De Marseille All CHILD, ADULT 54 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2016-06 01/01/2017 01/01/2020 01/01/2021 13/09/2016 13/09/2016 https://clinicaltrials.gov/study/NCT02897986 Recurrent/Refractory Hospital/University/Research Institute N N Y France Multiple cancer types Any solid tumours Propranolol Safety and/or Dose Phase 1 DB00571 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, To determine the safety and efficacy of the combination of propranolol plus chemoradiation, Up to 5 years; Progression Free Survival, Imaging findings from first radiation treatment to progression of disease, UP to 5 years Roswell Park Cancer Institute All ADULT, OLDER_ADULT 106 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT I 630420 04/01/2021 04/01/2027 04/01/2027 23/12/2020 04/05/2024 https://clinicaltrials.gov/study/NCT04682158 Localised/Locoregional Hospital/University/Research Institute Y Y N United States GI Esophageal Cancer Propranolol Safety and/or Dose; PFS; OS Phase 2 DB00571 N
NCT05979818 Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer BRIO RECRUITING Non Small Cell Lung Cancer|Propranolol DRUG: Propranolol hydrochloride; DRUG: Sintilimab; DRUG: Chemotherapy Objective Response Rate (ORR), The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), 2 years; Disease Control Rate (DCR), Disease Control Rate (DCR) The proportion of patients with a complete response or partial response or stable disease to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), 2 years; Adverse events (AEs), Based on the physical examination, vital signs, laboratory findings, and medical examinations, and record the type, incidence, severity of AEs, which were graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, 2 years Second Xiangya Hospital of Central South University All ADULT, OLDER_ADULT 6 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT XYEYY20230705 13/11/2024 31/08/2025 31/12/2026 08/07/2023 19/11/2024 https://clinicaltrials.gov/study/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 DB00571 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, Assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number., 2 years Emory University All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00002186; NCI-2021-00437; WINSHIP5200-20; P30CA138292 20/05/2021 01/01/2026 01/01/2027 19/04/2021 06/10/2024 https://clinicaltrials.gov/study/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 DB00571 N
NCT03384836 Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery SUSPENDED 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), Adverse events and toxicities will be summarized by dose level using frequencies and relative frequencies., Up to 12 weeks; Overall response rate (ORR) per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) version 1.1 (Phase II), ORR is defined as partial or complete response within 6 months of initiating combination therapy., Up to 6 months Roswell Park Cancer Institute All ADULT, OLDER_ADULT 47 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT I 53217; NCI-2017-02210; I 53217 31/01/2018 31/01/2025 31/01/2025 27/12/2017 11/12/2024 https://clinicaltrials.gov/study/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 DB00571 N
NCT03108300 Use of Propranolol Hydrochloride in the Treatment of Metastatic STS UNKNOWN Malignant Soft Tissue Sarcoma DRUG: Propranolol Hydrochloride; DRUG: Doxorubicin Progression Free Survival, Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD., an average of 1 year Ain Shams University All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CURE002 30/08/2019 30/08/2020 30/08/2021 04/11/2017 23/02/2018 https://clinicaltrials.gov/study/NCT03108300 Advanced/Metastatic Hospital/University/Research Institute N N N Egypt Soft Tissue Sarcoma Any soft tissue sarcoma Propranolol PFS; OS Phase 2 DB00571 N
NCT05741164 Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer 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, Efficacy as determined by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Will be summarized using frequencies and relative frequencies. The best response within the first 6 months will be determined as the best objective response., Up to 6 months Roswell Park Cancer Institute Female ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT I 2612022; NCI-2023-00641; I 2612022 22/10/2024 15/12/2026 15/12/2027 23/02/2023 18/11/2024 https://clinicaltrials.gov/study/NCT05741164 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N N N United States Breast Breast Cancer - TNBC Propranolol Response rate Phase 2 DB00571 N
NCT05451043 Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) 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, combination of gemcitabine+nab-paclitaxel+propranolol+durvalumab+tremelimumab's objective response rate is greater than or equal to 50 , Assessed one year after enrollment of last participant; Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in hepatocellular carcinoma, propranolol + durvalumab + tremelimumab objective response rate is greater than 45 , Assessed one year after enrollment of last participant; Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in biliary tract tumors, To demonstrate in unresectable BTC (gallbladder, cholangiocarcinoma of the biliary tracts including ampullary carcinomas) that the combination of gemcitabine + cisplatin + propranolol + durvalumab + tremelimumab's objective response rate is greater than 50 , Assessed one year after enrollment of last participant AHS Cancer Control Alberta All ADULT, OLDER_ADULT 62 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IIT-0027 07/05/2023 10/01/2025 10/01/2028 07/11/2022 06/12/2024 https://clinicaltrials.gov/study/NCT05451043 Advanced/Metastatic Hospital/University/Research Institute N N N Canada GI Cholangiocaricnoma; Pancreatic Cancer; Liver Cancer Propranolol Other (specify) Phase 2 DB00571 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, Determine the progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), 3 months Niels Junker All ADULT, OLDER_ADULT 80 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT SA2115 17/08/2021 01/01/2028 12/01/2028 27/07/2023 27/07/2023 https://clinicaltrials.gov/study/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 DB00571 N
NCT02962947 MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients UNKNOWN Melanoma DRUG: Propranolol; DRUG: Placebo Effect of Propranolol on overall survival for melanoma patients in stage II/IIIA (T2, N0 or N1, M0), To assess the effect of treatment with propranolol 80 mg retard (R) on overall survival for cutaneous malignant melanoma (CMM) patients in stage II/IIIA (T2, N0 or N1, M0) at five years of follow---up,after at least one year of treatment. Chi-square and Fisher's exact tests will be used to analyze the associations between the categorical variables. Logistic regression adjusting for confounding factors will be also performed. Wilcoxon tests will be used to compare continuous variables. Overall survival and Disease Free Survival curves will be estimated by the Kaplan-Meier method. Log-rank test will be used to compare survival time between groups and Cox proportional hazards models to evaluate the effect of -blockers treatment and duration of treatment on melanoma recurrence and mortality, considering stratification factors., 5 years Azienda Sanitaria di Firenze All ADULT, OLDER_ADULT 546 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|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/study/NCT02962947 Localised/Locoregional Hospital/University/Research Institute N N N Italy Skin Melanoma Propranolol OS; DFS/RFS/EFS Phase 2/3 DB00571 N
NCT06442709 Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients ACTIVE_NOT_RECRUITING Nasopharyngeal Carcinoma DRUG: Tocilizumab Asprin; OTHER: Placebo Tumor progression and metastasis, After the patients are diagnosed and treated, CT scans is used semi-annually to determine the progression and metastasis of tumor., Five to Ten years Affiliated Hospital of Nantong University All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT 2023-K015 08/01/2021 07/01/2024 07/01/2024 06/04/2024 06/04/2024 https://clinicaltrials.gov/study/NCT06442709 Advanced/Metastatic Hospital/University/Research Institute Y N N China Head and Neck Nasopharyngeal Cancer Tocilizumab Recurrence rate Phase 1 DB08895 N
NCT04512105 Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia ACTIVE_NOT_RECRUITING Acute Myeloid Leukemia|Chronic Lymphocytic Leukemia|AML, Adult|CLL|CLL, Relapsed|CLL, Refractory DRUG: Pitavastatin; DRUG: Venetoclax Maximum Tolerated Dose for PIT administered with VEN-containing Standard of Care (SOC) regimens, Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding to PIT to treatment with stable doses of VEN anti-CD20 antibodies (patients with CLL) or VEN with hypomethylating agents (patients with AML)., From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years.; Recommended Phase 2 Dose for PIT administered with VEN-containing SOC regimens, Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding to PIT to treatment with stable doses of VEN anti-CD20 antibodies (patients with CLL) or VEN with hypomethylating agents (patients with AML)., From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years.; Identifying Dose Limiting Toxicities (DLTs) for PIT administered with VEN-containing SOC regimens, To evaluate the safety and tolerability of administering PIT in combination with VEN-containing SOC in patients with AML or CLL ., From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years.; Identifying overall Adverse Event Profile of PIT when given with VEN-containing SOC regimens, To evaluate the adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0., From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years.; Complete Response Rate, Primary efficacy endpoint is the complete response rate of subjects who receive PIT when given with VEN-containing SOC regimens. The 2018 International Working Group for Chronic Lymphocytic Leukemia (iwCLL) and 2017 European LeukemiaNet (ELN) definitions of Complete Response (CR) will be utilized to determine the CR rate., From the start date of treatment until 30 days after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 2 years. University of California, Irvine All ADULT, OLDER_ADULT 6 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 20205930; CDMRP-CA190644; UCI 18-128 12/02/2020 20/07/2024 06/01/2026 13/08/2020 21/10/2024 https://clinicaltrials.gov/study/NCT04512105 Localised/Locoregional Hospital/University/Research Institute N N N United States Leukemia Acute Myeloid Leukemia, Adult; Chronic Lymphocytic Leukemia Pitavastatin Safety and/or Dose Phase 1 DB00554 N
CTIS2024-511452-40-00 Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) Not Recruiting Oncology - Glioblastoma (GBM)
MedDRA version: 20.0Level: PTClassification code: 10018336Term: Glioblastoma Class: 100000004864;Therapeutic area: Diseases [C] - Neoplasms [C04] Product Name: Troriluzole, Product Code:PRD8836295, Pharmaceutical Form: CAPSULE, Other descriptive name: , Strength: , Product Name: ADI-PEG-20, Product Code:PRD254241, Pharmaceutical Form: POWDER AND SOLVENT FOR INTRAMUSCULAR INJECTION., Other descriptive name: , Strength: Main Objective: 1. To identify experimental therapies that improve overall survival (OS) for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment
2. To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application;Secondary Objective: To evaluate Progression Free Survival (PFS), duration of response, and tumour response by each biomarker/therapeutic combination, To evaluate OS by each biomarker/therapeutic combination, To determine short- and long-term safety signals and quality of life (QOL) measures of an experimental Arm in GBM patients versus standard of care;Primary end point(s): Overall Survival defined from the time of randomization to death from any cause Global Coalition For Adaptive Research Inc. Female 18 - 65+ 1645 Global Coalition for Adaptive Research 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: 3 NCT03970447;2020-002250-24;128245 03/06/2022 10/06/2024 21/10/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2024-511452-40-00 Advanced/Metastatic; Recurrent/Refractory Collaborative Group Y N N United States CNS Glioblastoma Riluzole OS; QoL Phase 2/3 DB00740 N
CTIS2024-511626-30-00 MEtformin as a MEtabolic iNTervention in Oesophageal adenocarcinomas to improve response to neoadjuvant chemoradiotherapy Not Recruiting Oesophageal adenocarcinoma;Therapeutic area: Diseases [C] - Neoplasms [C04] Product Name: Metformin Aurobindo 500 mg film-coated tablets, Product Code:PRD6217371, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: , Strength: Main Objective: The primary objective of this clinical trial is to determine whether 2 weeks metformin treatment activates the tumour immune microenvironment measured by M2 to M1 macrophage polarization, CD8 intratumoral T cell infiltration and increase of the CD8:CD163 ratio when comparing pre- and post-treatment tumour biopsies.;Secondary Objective: Tolerability and toxicity of metformin, Metabolic change of cancer cells, Determine whether SCENITH can be used to assay the metabolic impact on cancer and im-mune cells, Pathological response according to the Mandard criteria., Progression-free survival (PFS)., Overall survival (OS)., Determine whether metformin induces a metabolic switch in macrophages, T cells and cancer cells., Determine whether changes in the tumour immune microenvironment can also be detected in subgroups of peripheral blood mononuclear cells (PBMCs) taken at the same time points., To establish autologous immune cell co-cultures with primary tumour cells to investigate im-mune cell-tumour cell interactions and anti-tumour responses in the presence of metformin., Determine changes in cytokine expression in serum before and after metformin treatment.;Primary end point(s): Metabolic switch in macrophages measured by M2 to M1 macrophage polarization within the tumour immune microenvironment and the number of CD8 intratumoral T-cell infiltration determined with single cell mRNA sequencing. Amsterdam UMC Stichting Female 18 - 65+ 14 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: 19/04/2024 21/10/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2024-511626-30-00 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands GI Esophageal Cancer Metformin Biomarker Phase 1 DB00244 N
CTIS2024-518267-35-00 Atorvastatinbehandling til patienter med de Philadelphia-negative kronisk myeloproliferative neoplasier - essentiel trombocytose, polycythemia vera og pr fibrotisk myelofibrose. Not Recruiting Blod cancer;Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15] Product Name: Atorvastatin 20mg Film-Coated Tablets, Product Code:PRD8683175, Pharmaceutical Form: COATED TABLET, Other descriptive name: , Strength: , Product Name: Atorvastatin 40mg Film-Coated Tablets, Product Code:PRD8683177, Pharmaceutical Form: COATED TABLET, Other descriptive name: , Strength: , Product Name: Atorvastatin 80mg Film-Coated Tablets, Product Code:PRD8683179, Pharmaceutical Form: COATED TABLET, Other descriptive name: , Strength: Main Objective: 1. In patients with MPNs undergoing Best Available Therapy (BAT), to investigate the effect of adjuvant treatment with atorvastatin assessed by inflammatory markers and cell counts.;Secondary Objective: 2. To asses biochemical markers for inflammation and disease burden in a population of MPN patients who are followed prospectively during statin treatment, as well as to assess the relationship to the development of symptoms, thrombosis and transformation to myelofibrosis and AML. 3. To asses the thrombophilia profile in MPN patients before and during atorvastatin treatment. 4. To asses the number and functionality of circulating immune cells before and during atorvastatin treatment. 5. To investigate the effect of statins on the gut microbiome and possible correlations in treatment response.;Primary end point(s): 1. Inflammatory parameters: hs-CRP, inflammatory cytokines, leukocyte count, platelet count and neutrophil/lymphocyte ratio (NLR). Region Sjaelland Female 18 - 65+ 40 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: 2022-003009-31 16/10/2024 11/11/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2024-518267-35-00 Any/All Stages Local/National government N N N Denmark Other Haem-onc Other non-lymphoma/non-leukemia haem-onc cancer Atorvastatin Biomarker Phase 1 DB01076 N
CTIS2024-515251-37-00 Effect of obesity due to the action of aspirin and its effectiveness in therapy for the treatment of colon cancer. Not Recruiting Colorectal cancer;Therapeutic area: Diseases [C] - Neoplasms [C04];Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02];Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Product Name: , Product Code:SCP101851519, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: ACETYLSALICYLIC ACID, Product Code:SUB12730MIG, Pharmaceutical Form: GASTRO-RESISTANT COATED TABLET, Other descriptive name: , Strength: Main Objective: To evaluate the effect of a short course (one week) of enteric-coated acetylsalicylic acid at low doses (100 mg/24h) on platelet COX-1 and COX-2 in patients diagnosed with colorectal cancer (CRC), comparing these effects in obese and non-obese patients. And evaluate the effects of another short course (one week) of different doses of acetylsalicylic acid (300 mg/day, 100 mg/12h or maintain 100 mg/24 hours) on COX-1 and COX-2 in platelets, healthy colonic tissue and tumor in patients diagnosed with CRC comparing these effects in obese and non-obese patients.;Secondary Objective: To evaluate the effect of ASA on indirect biomarkers of its action at a systemic level: the platelet activity of COX-1 will be investigated through TXB2 levels in serum; and platelet activity in vivo through urinary levels of TX-M., To investigate the role of inflammatory and anti-inflammatory cytokines in platelet activation in this environment., To investigate the degree of COX-1 and COX-2 acetylation in normal and tumor tissue after exposure of patients to ASA in the phase 2 study., To evaluate the effect of ASA on PGE2 and P-S6 levels in the CRC mucosa., To evaluate the effect of ASA on the levels of specialized lipid markers including those derived from ASA (AT-SPMs).;Primary end point(s): Effect of two courses (1 week/course) of different doses of ASA on COX-1 and COX-2 in patients diagnosed with colorectal cancer Fundacion Instituto De Investigacion Sanitaria Aragon Female 18 - 65+ 60 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: 2021-005999-18 16/10/2024 11/11/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2024-515251-37-00 Localised/Locoregional Hospital/University/Research Institute N Y N Spain GI Colon Cancer; Rectal Cancer Acetylsalicylic Acid Safety and/or Dose; Response rate Phase 1 DB00945 N
ACTRN12624000917538 Efficacy and safety of cetuximab and prochlorperazine combined for solid organ transplant patients with advanced Cutaneous Squamous Cell Carcinoma: CetPro study Not yet recruiting skin cancer;solid organ transplant recipients;
skin cancer
solid organ transplant recipients;Cancer - Non melanoma skin cancer;Surgery - Other surgery Efficacy and safety of cetuximab and prochlorperazine combined
Day 1: Cetuximab will be administered at 500mg/mg2 via intravenous infusion.
Day 8: Cetuximab will be administered at 250mg/mg2 via intravenous infusion. Prochlorperazine will then be administered at a dose of 0.8mg/kg via intravenous infusion 1 hour after the completion of cetuximab. Cetuximab and prochlorperazine (0.8mg/kg) will be administered in combination on a weekly basis for a total of 6 weeks (Day 8, Day 15, Day 22, Day 29, D36, D43) (total treatment period of 7 weeks).
Depending on the response this treatment can be reconducted for a new period of 6 weeks.
All patient assessment/monitoring is recorded in the patient clinical record including observations, medication charts and clinical notes.
If necessary, depending on clinician decision, antihistamines and corticosteroids will be administered 30 min before cetuximab administration: Oral Loratadine 10mg and
Intravenous hydrocortisone 100mg. To determine the disease control rate (DCR) as a measure of efficacy. [as assessed by the investigator using RECIST 1.1 criteria DCR is defined as the percentage of patients whose disease either shrinks or remains stable over a specific time period.
at 6- and 12-weeks post-commencement of combination treatment (Cetuximab + PCZ).] The University of Queensland All 18 Years - No limit 10 Metro South Health Research Support Scheme (MSH RSS) Interventional Study Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy; 01/08/2024 29/07/2024 19/08/2024 https://anzctr.org.au/ACTRN12624000917538.aspx Advanced/Metastatic Hospital/University/Research Institute N N N Australia Skin Other skin cancer Prochlorperazine Safety and/or Dose; Response rate; PFS; Biomarker Phase 2 DB00433 N
CTRI/2024/08/072823 A randomized controlled trial to evaluate if the use of a combination of chemotherapy and immunotherapy results in an increased surgical resection rate for patients with unresectable oral cavity cancers when compared to standard chemotherapy. Not Yet Recruiting Health Condition 1: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 2: C029- Malignant neoplasm of tongue, unspecified Intervention1: CHEMO-IMMUNOTHERAPY ARM [Carboplatin + Paclitaxel + OMT (Tab. Methotrexate 9 mg/m2 once weekly + Tab. Celecoxib 200mg BD+ Erlotinib 100mg OD) + Nivolumab]
: Inj. Carboplatin AUC5 IV q 21 days x 4 doses +
Inj. Paclitaxel 175mg/m2 IV every 21 days x 4 doses +
Tab. Methotrexate 9 mg/m2 per oral once weekly x 12 weeks +
Tab. Celecoxib 200mg per oral twice a day x 12 weeks+
Tab. Erlotinib 100mg per oral once a day x 12 weeks +
Inj. Nivolumab 0.3mg/Kg IV every 21 days x 4 doses
TOTAL DURATION OF TREATMENT- 12 weeks
Control Intervention1: Treatment of Physicins choice (TPC): [Options: TPF, TP, Carboplatin + Paclitaxel): Physician's choice of standard chemotherapy
Options:
1. TPF x4 doses (Inj. Cisplatin 60mg/m2 IV q 21 days + Inj. Docetaxel 60mg/m2 IV q 21 days +Inj. 5Fluro uracil 750mg/m2 IV D1-5 q 21 days x 4 doses)
OR
2. TP x 4 doses (Inj. Cisplatin 75mg/m2 IV q 21 days+
Inj. Docetaxel 75mg/m2 IV q 21 days x 4 doses)
OR
3. Inj. Carboplatin AUC5 IV q 21 days +Inj. Paclitaxel 175mg/m2 IV q 21 days x 4 doses
TOTAL DURATION OF TREATMENT- 12 WEEKS
To compare the efficacy as measured by R0 resection rate of the study regimen as compared to standard treatment in patients with advanced OCSCCTimepoint: At surgery done at week 8 or week 12 CMC Vellore - - 106 1. CMC Fluid Research Grant2. Conquer Cancer Grant 2024 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 16/09/2024 21/08/2024 16/09/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=112953 Localised/Locoregional Hospital/University/Research Institute N Y N India Head and Neck Other Head and Neck Celecoxib Other (specify) Phase 2 DB00482 N
CTRI/2024/10/075166 A clinical trial to compare the effect of two neoadjuvant chemotherapy drug regimens in technically unresectable head and neck cancer. Not Yet Recruiting Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Intervention1: ARM A - NEOADJUVANT CHEMOTHERAPY REGIMEN
1. Inj. PACLITAXEL
2. Inj. CISPLATIN
3. inj. 5 FLURO-URACIL (5FU): ON WEEKLY BASIS FOR 9 CYCLES:-
1. Inj. PACLITAXEL
DOSE- 100 mg IV infusion on DAY 01, WEEKLY FOR 9 CYCLES
2. Inj. CISPLATIN
DOSE- 50 mg IV infusion on
DAY 01 , WEEKLY FOR 9 CYCLES
3. Inj. 5 FLURO URACIL( FU )
DOSE- 500 mg/m2 IV infusion over 6 HOUR on DAY-01, WEEKLY FOR 9 CYCLES
Control Intervention1: ARM B -
NEOADJUVANT CHEMOTHERAPY ORAL METRONOMIC CHEMOTHERAPY,OMCT
1. TAB GEFITINIB 250MG
2. TAB CELECOXIB 200MG
3. TAB METHOTREXATE 15MG/M2: ON MONTHLY BASIS FOR 3 CYCLES:-
1. TAB GEFITINIB 250MG
DOSE- 1TAB PO DAILY FOR 3 MONTHS
2. TAB CELECOXIB 200MG
DOSE- PO 1TAB TWICE DAILY FOR 3 MONTHS
3. TAB METHOTREXATE 15MG/M2
DOSE-15MG/M2(TOTAL DOSE CALCULATED AS PER SURFACE BODY AREA) 1TAB PO ONCE WEEKLY FOR 3 MONTHS
1. Compare proportion of patients eligible for radical treatment.
2. Assess loco-regional disease control at 3 and 6 months.Timepoint: 18 months Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital Sawangi Wardha - - 50 Jawaharlal Nehru Medical College Sawangi Wardha and Acharya Vinoba Bhave rural Hospital,Sawangi, Wardha, Pin code- 442001, Maharashtra, India Interventional Study Randomized, Parallel Group Trial Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable 25/10/2024 11/10/2024 14/10/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=116079 Advanced/Metastatic Hospital/University/Research Institute Y N N India Head and Neck Pharyngeal Cancer; Oropharyngeal Cancer; Nasopharyngeal Cancer Celecoxib Response rate Phase 2 DB00482 N
CTRI/2024/10/075019 Effectiveness of the drug Sirolimus in treatment of vascular anomalies. Not Yet Recruiting Health Condition 1: C00-D49- Neoplasms Intervention1: Sirolimus administration: Sirolimus will be given at a dose of 0.8 mg/m twice daily to each patient. Maximum dose is set as 5 mg/dose. The first dose of the drug will be supervised by the PI. If dose is not concurrent with 1 tab/ half tab, then tablet will be crushed and disintegrated in 10 ml water immediately prior to administration and the required dose will be administered. If patients vomits within 20 mins of administration, the dose of drug will be repeated. Patient/ guardian will be explained on how to take the subsequent doses. Total duration would be 6 months of administration.
Control Intervention1: Not applicable: Not applicable
Reduction in size of vascular anomalyTimepoint: 6 month Dr Saurav Sharma(self) - - 30 Department of Pediatrics, AIIMS NEW DELHI, Ansari Nagar, New Delhi, India. Pin-110029. Interventional Study Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable 31/10/2024 09/10/2024 14/10/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=110398 Localised/Locoregional Other N N Y India Multiple cancer types Other multiple cancer group (specify) Sirolimus Response rate Phase 2 DB00877 N
ACTRN12624001353583 Perioperative propranolol and celecoxib (ProCel) in stage III melanoma Not yet recruiting Melanoma, stage III;
Melanoma, stage III;Cancer - Malignant melanoma Participants randomised to the intervention arm will receive surgery (wide local excision of melanoma or dissection if the metastasis is in a lymph node) plus the ProCel regimen perioperatively, as detailed below.
Oral propranolol
Days 1-2: 20mg twice-daily
Days 3-5: 40mg twice-daily
Day 6 (day of surgery): 60mg twice-daily
Days 7-13: 40mg twice-daily
Days 14-20: 20mg twice-daily
Oral celecoxib
Days 1-20: 200mg twice-daily
Adherence will be assessed by the research team, based on unused tablet count and patient self-report. Change in tumour immune and proliferative markers (e.g. B2M-c, CD11c, CD14, CD141, CD163, CD16a-c, CD1c-c, CD20, CD27-c, CD31, CD34, CD38, CD39, CD3e, CD4, CD45, CD45RO, CD68, CD8, CollagenIV, FOXP3, GZMB, HLA-A, HLA-DR, HLA-E, ICOS, IDO1, Ki-67, LAG3, MITF-c, MLANA-c, PD-1, PD-L1, PMEL-c, S100B-c, SMA, SOX10-c, TBET-c, TCF7-c, TIM3-c, Vimentin and VISTA) in nodal and/or cutaneous metastatic melanoma (this will be assessed as a composite outcome)[Imaging mass cytometry Baseline and day 6 after commencing the ProCel regimen] Sydney Local Health District All 18 Years - 85 Years 40 Sydney Cancer Partners Interventional Study Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy; 12/11/2024 11/11/2024 18/11/2024 https://anzctr.org.au/ACTRN12624001353583.aspx Advanced/Metastatic Hospital/University/Research Institute Y N N Australia Skin Melanoma Celecoxib; Propranolol QoL; Biomarker Phase 2 DB00482; DB00571 N
CTRI/2024/11/076460 Sirolimus treatment to reduce size of rhabdomyoma (a tumor in the heart) in children. Not Yet Recruiting Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere Intervention1: Sirolimus administration to children with cardiac rhabdomyoma: Eligible participants will be randomized into two groups: an intervention arm, which will receive sirolimus at an initial dose of 1 mg/m , titrated to a maximum of 3 mg/m based on therapeutic monitoring, administered orally once daily for 3 months, and a control arm receiving standard care. Dosing adjustments in the intervention group will be guided by sirolimus trough levels to maintain a therapeutic range (e.g., 5-15 ng/mL). Throughout the study, participants will undergo regular safety monitoring, including assessments for infections, blood counts, liver function (ALT, AST), and kidney function.
Control Intervention1: Spontaneous regression: Participants in control arm will receive standard care. The aim of this study is to compare efficacy of sirolimus in cardiac rhabdomyoma regression compared to spontaneous regression.
The proportion of children having more than 50 reduction in the size of the largest cardiac rhabdomyoma at 3 months follow upTimepoint: At 1 month, 2 month and 3 month follow up after administrating sirolimus. Department of Cardiology, All India Institute Of Medical Sciences, New Delhi - - 40 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:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded 15/11/2024 08/11/2024 11/11/2024 http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=111622 Localised/Locoregional Hospital/University/Research Institute Y N Y India Soft Tissue Sarcoma Rhabdomyosarcoma Sirolimus Response rate Phase 3/4 DB00877 N
NCT06428045 STARLITE for Unresectable High-Grade Gliomas STARLITE NOT_YET_RECRUITING High Grade Glioma PROCEDURE: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT); DRUG: Abacavir; DRUG: Lamivudine; DRUG: Ritonavir; DRUG: Temozolomide; RADIATION: Focal Radiotherapy Number of Participants Experiencing Dose-Limiting Toxicity, The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0)., Up to 28 days; Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events, The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0)., Up to 12 months University of Miami All ADULT, OLDER_ADULT 24 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 20231163 03/01/2025 31/03/2029 31/03/2030 24/05/2024 27/11/2024 https://clinicaltrials.gov/study/NCT06428045 Localised/Locoregional Hospital/University/Research Institute N Y N United States CNS Glioma Ritonavir Safety and/or Dose; Response rate; PFS; OS Phase 1 DB00503 N
NCT06698822 A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2 Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA NOT_YET_RECRUITING Cutaneous T-Cell Lymphoma DRUG: tofacitinib 2 cream Safety and adverse events (AE's), 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 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2023-0747; NCI-2024-09674 05/06/2025 19/10/2026 19/10/2026 21/11/2024 21/11/2024 https://clinicaltrials.gov/study/NCT06698822 Localised/Locoregional Hospital/University/Research Institute N N N United States Lymphoma Cutaneous T-Cell Lymphoma Tofacitinib Safety and/or Dose; Response rate Phase 2 DB09216 N
NCT06599762 Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia MYELO-CAN:TXA NOT_YET_RECRUITING Myelodysplastic Syndromes|Acute Myeloid Leukemia DRUG: Tranexamic acid; DRUG: Placebo Patient enrollment feasibility, The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active), 2 months University of Manitoba All ADULT, OLDER_ADULT 75 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT CHI-001-1 11/01/2024 11/01/2026 11/01/2027 19/09/2024 19/09/2024 https://clinicaltrials.gov/study/NCT06599762 Any/All Stages Hospital/University/Research Institute Y N N Canada Leukemia; Other Haem-onc Acute Myeloid Leukemia, Adult; Myelodysplastic Syndromes Tranexamic Acid Other (specify) Not available/Missing DB07615 N
NCT06644079 Window of Opportunity Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma NOT_YET_RECRUITING Cutaneous Squamous Cell Carcinoma DRUG: Tranexamic acid Percentage of subjects who have a reduction in tumor size, Determine the percentage of subjects who have a reduction in tumor size at the time of definitive surgery, as compared to tumor size at baseline. This is measured by comparing the total tumor area before treatment with the total tumor area at the time of definitive surgery. Tumor area will be measured via images and will be calculated using length x width x height in mm., 35 days University of Florida All ADULT, OLDER_ADULT 32 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT UF-CUT-003 02/01/2025 04/01/2026 04/01/2026 16/10/2024 16/10/2024 https://clinicaltrials.gov/study/NCT06644079 Localised/Locoregional Hospital/University/Research Institute N N N United States Skin Other skin cancer Tranexamic Acid Response rate Phase 2 DB07615 N
NCT06695026 A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects with Hepatocellular Carcinoma NOT_YET_RECRUITING Hepatocellular Carcinoma (HCC) DRUG: RZ-001 Dose 1; DRUG: RZ-001 Dose 2; DRUG: RZ-001 Dose 3 Number of participants with adverse events (AEs) as graded by NCI CTCAE, Screening visit, up to 2 years; Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST, Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years; Overall response rate based on RECIST v1.1 and HCC mRECIST, Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years Rznomics, Inc. All ADULT, OLDER_ADULT 45 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT RZ-001-102 12/01/2024 08/01/2027 10/01/2027 19/11/2024 19/11/2024 https://clinicaltrials.gov/study/NCT06695026 Localised/Locoregional Company N N N Korea, Republic of GI Liver Cancer Valganciclovir Response rate Phase 1/2 DB00313 N
NCT06701812 Digoxin Medulloblastoma Study NOT_YET_RECRUITING Medulloblastoma|Medulloblastoma, Non-WNT/Non-SHH DRUG: Digoxin Progression Free Survival at 4 months (PFS4), Proportion of patients with progression free survival at 4 months after initiation of treatment., 4 months H. Lee Moffitt Cancer Center and Research Institute All CHILD, ADULT 23 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT MCC-23221 11/01/2024 02/01/2026 02/01/2027 22/11/2024 22/11/2024 https://clinicaltrials.gov/study/NCT06701812 Recurrent/Refractory Hospital/University/Research Institute N N Y United States CNS Medulloblastoma Digoxin PFS Phase 2 DB00390 N
NCT06630221 Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations NOT_YET_RECRUITING Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia DRUG: Eltrombopag (EPAG) Response Rate as assessed by hematologic response, Response rate will be assessed to determine whether treatment with EPAG can induce a hematologic response. The different types of hematologic improvement are Erythroid response (non-transfusion dependent, Erythroid response (transfusion dependent), Platelet response (pretreatment, \> 20 109/L), Platelet response (pretreatment, \< 20 109/L), Neutrophil response, and Progression or relapse after HI (after reaching maximum dose, and on maximum dose for 12 weeks)., At end of treatment (approximately up to 12 weeks) Case Comprehensive Cancer Center All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CASE2924 01/01/2025 01/01/2028 01/01/2030 10/08/2024 10/09/2024 https://clinicaltrials.gov/study/NCT06630221 Localised/Locoregional Hospital/University/Research Institute N N N United States Leukemia; Other Haem-onc Leukemia - Other; Myelodysplastic Syndromes Eltrombopag Response rate Phase 2 DB06243 N
NCT06639724 Perioperative Fostamatinib with Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer NOT_YET_RECRUITING Pancreatic Ductal Adenocarcinoma (PDAC) COMBINATION_PRODUCT: Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) Surgical delay, Number and percentage of participants who experience surgical delay, as measured by the proportion of enrolled participants for whom pancreatic resection cannot be performed within 6 weeks of the last pre-operative treatment cycle., 6 weeks from the last pre-operative treatment cycle University of California, San Diego All ADULT, OLDER_ADULT 36 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 810834 12/01/2024 06/01/2027 12/01/2028 15/10/2024 16/10/2024 https://clinicaltrials.gov/study/NCT06639724 Localised/Locoregional Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Fostamatinib Other (specify) Phase 1 DB00176 N
NCT06389201 Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients NOT_YET_RECRUITING Nasopharyngeal Carcinoma DRUG: HCQ; OTHER: Placebo Recurrence and metastasis, After the patients are diagnosed and treated, CT scans is used semi-annually to determine the progression, recurrence and metastasis of tumor., Five to Ten years. Affiliated Hospital of Nantong University All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT 2024HCQ 05/01/2024 31/12/2024 31/12/2026 29/04/2024 29/04/2024 https://clinicaltrials.gov/study/NCT06389201 Localised/Locoregional Hospital/University/Research Institute Y N N China Head and Neck Nasopharyngeal Cancer Hydroxychloroquine Recurrence rate Not available/Missing DB01275 N
NCT06408298 HCQ in Resectable Localized Prostate Cancer NOT_YET_RECRUITING Resectable Localized Prostate Cancer DRUG: Hydroxychloroquine Sulfate 400Mg Tab; DRUG: Placebo Change in expression of markers of autophagy, To determine the effects of hydroxychloroquine (HCQ) on markers of autophagy, such as p62, LC3-II and NBR-1 in prostate cancer tissue of patients with resectable localized prostate cancer who undergo radical prostatectomy., Day 1, Day 26/27, Day of surgery(approximately day 30) Lionel.D.Lewis, MD Male ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE 23LEW054; STUDY02002054 11/01/2024 06/01/2028 06/01/2028 05/10/2024 15/11/2024 https://clinicaltrials.gov/study/NCT06408298 Localised/Locoregional Hospital/University/Research Institute Y N N United States Urological Prostate Cancer Hydroxychloroquine Biomarker Phase 1 DB01275 N
NCT06330038 Anesthesia and Non-small Cell Lung Cancer Recurrence GASTIVA NOT_YET_RECRUITING Non-small Cell Lung Cancer|Surgery|Anesthesia DRUG: Propofol; DRUG: Inhaled anesthetics Recurrence free survival, Time from surgery to the earliest date of local recurrence/metastasis or death from any cause, whichever comes first, Within 3 year after curative resection for NSCLC Samsung Medical Center All ADULT, OLDER_ADULT 5384 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION SMC 2024-01-065 05/01/2024 31/12/2028 31/12/2028 26/03/2024 28/03/2024 https://clinicaltrials.gov/study/NCT06330038 Localised/Locoregional Hospital/University/Research Institute N N N Korea, Republic of Lung Non-Small Cell Lung Cancer Propofol OS; DFS/RFS/EFS Phase 4 DB00818 N
NCT06636734 Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial NOT_YET_RECRUITING Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8|Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary|Metastatic Head and Neck Squamous Cell Carcinoma|Metastatic Hypopharyngeal Squamous Cell Carcinoma|Metastatic Laryngeal Squamous Cell Carcinoma|Metastatic Nasopharyngeal Squamous Cell Carcinoma|Metastatic Oral Cavity Squamous Cell Carcinoma|Metastatic Oropharyngeal Squamous Cell Carcinoma|Metastatic Paranasal Sinus Squamous Cell Carcinoma|Recurrent Head and Neck Squamous Cell Carcinoma|Recurrent Hypopharyngeal Squamous Cell Carcinoma|Recurrent Laryngeal Squamous Cell Carcinoma|Recurrent Nasopharyngeal Squamous Cell Carcinoma|Recurrent Oral Cavity Squamous Cell Carcinoma|Recurrent Oropharyngeal Squamous Cell Carcinoma|Recurrent Paranasal Sinus Squamous Cell Carcinoma|Stage IV Hypopharyngeal Carcinoma AJCC V8|Stage IV Laryngeal Cancer AJCC V8|Stage IV Lip and Oral Cavity Cancer AJCC V8|Stage IV Nasopharyngeal Carcinoma AJCC V8|Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8|Stage IV Sinonasal Cancer AJCC V8 PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; DRUG: Lovastatin; PROCEDURE: Magnetic Resonance Imaging; BIOLOGICAL: Pembrolizumab; PROCEDURE: Positron Emission Tomography Objective response rate (ORR), ORR will be defined as the proportion of subjects with partial response or complete response. ORR will be evaluated using Response Evaluation Criteria in Solid Tumors version (RECIST) (v)1.1 response criteria. ORR will be calculated with 95 confidence interval by binomial distribution., Up to 1 year Emory University All ADULT, OLDER_ADULT 28 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT STUDY00007740; NCI-2024-06118; STUDY00007740; WINSHIP6229-24; P30CA138292 31/12/2024 31/12/2027 31/12/2028 15/10/2024 27/11/2024 https://clinicaltrials.gov/study/NCT06636734 Advanced/Metastatic Hospital/University/Research Institute N N N United States Head and Neck Oropharyngeal Cancer Lovastatin Response rate; PFS; OS Phase 2 DB00678 N
NCT06549855 PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer NOT_YET_RECRUITING Endometrial Cancer|Endometrioid Carcinoma|Mismatch Repair Deficiency DRUG: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) Complete remission (CR) rate, No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor, From start of treatment to trial completion, an average of 3 months; Time to CR, Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR, From start of treatment to trial completion, an average of 3 months Peking University People's Hospital Female ADULT 10 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2024MMRdECFerSp 10/01/2024 07/01/2029 10/01/2029 08/12/2024 08/12/2024 https://clinicaltrials.gov/study/NCT06549855 Localised/Locoregional Hospital/University/Research Institute N N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate; Biomarker; Other (specify) Not available/Missing DB00358 N
NCT06687876 Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy MEMENTO NOT_YET_RECRUITING Oesophageal Adenocarcinoma|Tumor Microenvironment DRUG: Metformin activation of the tumour immune microenvironment after two week metformin treatment., Activation of the tumor immune microenvironment measured by M2 to M1 polarization, CD8 intratumoral T cell infiltration and an increase of CD3 to CD163 ratio when comparing tumor biopsies from before and after treatment., at enrollment and at end of metformin treatment at 2 weeks. Amsterdam UMC, location VUmc All ADULT, OLDER_ADULT 14 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2024.0935; 2024-511626-30-00 12/01/2024 12/01/2026 12/01/2030 14/11/2024 18/11/2024 https://clinicaltrials.gov/study/NCT06687876 Localised/Locoregional Hospital/University/Research Institute N N N Netherlands GI Esophageal Cancer Metformin Biomarker Phase 2 DB00244 N
NCT06353061 Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer NOT_YET_RECRUITING Cervical Cancer|Radiotherapy|Metformin|Hypoxia|PET/CT DRUG: Metformin; RADIATION: Radiotherapy; DRUG: Chemotherapy; DIAGNOSTIC_TEST: PET/CT The degree to which metformin improves the hypoxic index measured by CAIX PET, Using the uptake value parameter of CA-IX in PET/CT, comparing the changes in uptake values between the two scans as an indicator of improvement in hypoxia level, 1week after randomization Peking Union Medical College Hospital Female ADULT, OLDER_ADULT 51 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT LACC-MET 15/04/2024 08/01/2025 02/01/2026 04/08/2024 04/08/2024 https://clinicaltrials.gov/study/NCT06353061 Localised/Locoregional Hospital/University/Research Institute Y N N China Gynaecological Cervical Cancer Metformin PFS; Biomarker Phase 2 DB00244 N
NCT06627270 Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer NOT_YET_RECRUITING Oral Squamous Cell Carcinoma|Oral Cancer|Head and Neck Cancer|Head and Neck Carcinoma DRUG: Metronidazole; OTHER: Chlorhexidine Change in absolute amount of intraumoral bacteria as quantified by 16SrDNA qPCR, The difference between pre-treatment and post-treatment tumor bacteria burden will be assessed., Baseline, surgery (10 days post intervention) Case Comprehensive Cancer Center All ADULT, OLDER_ADULT 30 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT CASE6324 12/01/2024 10/01/2026 10/01/2027 10/04/2024 10/04/2024 https://clinicaltrials.gov/study/NCT06627270 Localised/Locoregional Hospital/University/Research Institute N N N United States Head and Neck Oropharyngeal Cancer Metronidazole Biomarker Phase 2 DB01233 N
NCT06616597 Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer NOT_YET_RECRUITING Prostate Cancer (Adenocarcinoma)|Metastatic Prostate Cancer DRUG: Abiraterone acetate; DRUG: Dexamethasone; DRUG: Metronidazole Number of participants with PSA30 response, Number of participants with castration resistant prostate cancer who have a 30 decline in PSA from baseline until 24 weeks., 24 weeks Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Male ADULT, OLDER_ADULT 58 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT J2485; IRB00453879 30/12/2024 30/12/2030 30/12/2030 27/09/2024 27/09/2024 https://clinicaltrials.gov/study/NCT06616597 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Urological Prostate Cancer Metronidazole Biomarker Phase 2 DB01233 N
NCT06554613 Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC NOT_YET_RECRUITING Non-Small Cell Lung Cancer DRUG: Olanzapine; DRUG: Nivolumab The Overall Survival OS , The Overall Survival OS From the time of a patient's diagnosis or the commencement of treatment, to the time of the patient's death., 24 months Second Affiliated Hospital of Nanchang University All ADULT, OLDER_ADULT 156 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT IIT-2024-6804 12/01/2024 12/01/2027 31/05/2028 15/08/2024 15/08/2024 https://clinicaltrials.gov/study/NCT06554613 Advanced/Metastatic Hospital/University/Research Institute N Y N China Lung Non-Small Cell Lung Cancer Olanzapine OS Phase 2 DB05990 N
NCT06484153 Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma NOT_YET_RECRUITING To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma|To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer|Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer DRUG: Pirfenidone; DRUG: Fruquintinib; DRUG: Pembrolizumab Progression Free Survival (PFS), The time from enrollment until tumor progression or death from any cause, whichever occurred first, 2 year; Occurrence of Grade 4 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days); Occurrence of Grade 3 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days Wuhan Union Hospital, China All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT union-P 22/07/2024 22/07/2026 30/12/2026 07/03/2024 07/03/2024 https://clinicaltrials.gov/study/NCT06484153 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Pirfenidone PFS Phase 1/2 DB01132 N
NCT06670976 Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma NOT_YET_RECRUITING Soft Tissue Sarcoma PROCEDURE: Biopsy; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Positron Emission Tomography; DRUG: Propranolol; RADIATION: Radiation Therapy; PROCEDURE: Surgical Procedure Incidence of adverse events, Will evaluate safety and tolerability of adding propranolol to standard radiation therapy for soft tissue sarcoma. Will determine the occurrence of a grade 3 or higher treatment related adverse events. Will summarize using frequencies and relative frequencies, with the grade 3 or higher toxicity rate estimated using a 90 credible region obtained by Jeffrey's prior method. Will summarize toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) by attribution and grade using frequencies and relative frequencies., Up to 5 weeks post-surgery Roswell Park Cancer Institute All ADULT, OLDER_ADULT 12 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT I-3905123; NCI-2024-08858; I-3905123 15/11/2024 15/11/2029 15/11/2029 11/01/2024 11/01/2024 https://clinicaltrials.gov/study/NCT06670976 Any/All Stages Hospital/University/Research Institute N N N United States Soft Tissue Sarcoma Any soft tissue sarcoma Propranolol Safety and/or Dose; Biomarker; Other (specify) Phase 1 DB00571 N
2022-001284-27 H1-antihistaminE treatment in combiNation with immunotHerapy in pAtieNts with advanced non small cell lung canCEr: A single- center phase II trial ENHANCE Ongoing NSCLC Drug: FEXOFENADINE HYDROCHLORIDE Objective response rate according to RECIST 1.1., ORR; defined as complete or partial response at any timepoint during study period. Med. Univ. Wien, Klinik f. Innere Med I, Onkologie All Adult 18-64 9 - Open https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001284-27/AT Advanced/Metastatic Hospital/University/Research Institute N N N Austria Lung Non-Small Cell Lung Cancer Fexofenadine Response rate; PFS; OS Phase 2 DB00800 N
ChiCTR2400087406 To compare the efficacy and safety of low-dose venetoclax combined with azole and full-dose venetoclax without azole in the treatment of newly diagnosed AML patients who are intolerant to intensive chemotherapy Pending Acute myeloid leukemia trial group:Low-dose venetoclax group (venetoclax 100-200mg/d, d1-28), combined with azole antifungal drugs (voriconazole, posaconazole, itraconazole, esaconazole and fluconazole, etc.);;Control group:The other group was full dose venetoclax (full dose group, not combined with azole antifungal drugs 100mg/d on the first day, 200mg/d on the second day, 400mg/d on the third day and thereafter until the 28th day, if not tolerated, the course of treatment could be reduced to 21 days without azole antifungal drugs.; Complete response Rate; The First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital) All 14 - trial group:30;Control group:30; Health Research Project of Anhui Province Interventional Study Cross-sectional 08/01/2024 26/07/2024 29/07/2024 https://www.chictr.org.cn/showproj.html?proj=230881 Any/All Stages Hospital/University/Research Institute Y N Y China Leukemia Acute Myeloid Leukemia, Adult Itraconazole; Posaconazole Response rate Other DB01029; DB01263 N
ChiCTR2400088782 Rosuvastatin combined with FOLFIRI chemotherapy regimen to improve the efficacy of advanced colorectal cancer Pending colorectal cancer Experimental Group:Oral adminstration of rosuvastatin, 20 mg, once daily.; Objective Response Rate; South China Hospital of Shenzhen University All 20 - 75 Experimental Group:28; Self funded Interventional Study Single arm 09/01/2024 27/08/2024 09/02/2024 https://www.chictr.org.cn/showproj.html?proj=240729 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Colon Cancer; Rectal Cancer Rosuvastatin Response rate Other DB01098 N
ChiCTR2400089169 Phase II clinical trial of lopinavir/ritonavir in patients with castration-resistant prostate cancer Pending prostate cancer Experimental group:lopinavir-ritonavir tablets; PSA assessment; Xiangya Hospital of Central South University Male 18 - 90 Experimental group:20; Self-Initiated Study (Self-Funded) Interventional Study Single arm 09/03/2024 09/03/2024 09/09/2024 https://www.chictr.org.cn/showproj.html?proj=241985 Advanced/Metastatic Hospital/University/Research Institute N N N China Urological Prostate Cancer Lopinavir; Ritonavir Biomarker Phase 2 DB00836; DB00503 N
NCT06437574 Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer RECRUITING Prostate Cancer DRUG: Vytorin; DRUG: Ezetimibe Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes., Our primary hypothesis is that maximum cholesterol lowering will increase CD8+ memory T cells and increase CD8+ T cell infiltration into prostate tissue. Change in CD8+ T cells in the prostate from baseline to 3 to 6 months is the primary endpoint., 3 to 6 months of cholesterol-lowering intervention Cedars-Sinai Medical Center Male ADULT, OLDER_ADULT 140 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION STUDY00003290; R01CA280060 16/07/2024 29/02/2028 31/05/2028 31/05/2024 10/08/2024 https://clinicaltrials.gov/study/NCT06437574 Localised/Locoregional Hospital/University/Research Institute N N N United States Urological Prostate Cancer Simvastatin Biomarker Phase 2 DB00641 N
NCT04616248 In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors RECRUITING Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Breast Carcinoma|Prognostic Stage IV Breast Cancer AJCC v8|Unresectable Breast Carcinoma|Metastatic Melanoma|Unresectable Melanoma|Cutaneous Squamous Cell Carcinoma|Merkel Cell Carcinoma|Soft Tissue Sarcoma|Bone Sarcoma|Sarcoma,Soft Tissue|Sarcoma of Bone|Basal Cell Carcinoma BIOLOGICAL: Anti-CD40 Agonist Monoclonal Antibody CDX-1140; DRUG: Poly ICLC; RADIATION: Radiation Therapy; BIOLOGICAL: Recombinant Flt3 Ligand; DRUG: Pembrolizumab; DRUG: Tocilizumab Incidence of adverse events, Up to 30 days; Maximum tolerated dose or maximum administered dose, The dose limiting toxicity rate will be estimated by cohort and dose-level (if appropriate) using 90 confidence intervals obtained by Jeffrey's prior method., Up to 30 days University of Southern California All ADULT, OLDER_ADULT 18 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT 1B-22-2; NCI-2022-07303; 1B-22-2 01/09/2023 01/09/2025 01/09/2026 11/04/2020 20/09/2024 https://clinicaltrials.gov/study/NCT04616248 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Multiple cancer types Multiple cancer types Tocilizumab Response rate; OS; Biomarker Phase 1 DB08895 N
NCT06391918 Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors RECRUITING Solid Tumor, Adult BIOLOGICAL: GEN2 + Valganciclovir Determine the recommended phase 2 dose (RP2D) of GEN2 by intravenous infusion, The RP2D will be determined by evaluating the number of subjects with treatment related adverse events and Dose Limiting Toxicities, First 28 days. GenVivo, Inc. All ADULT, OLDER_ADULT 91 INDUSTRY Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT Protocol GVO-1102 03/04/2024 03/01/2027 03/01/2028 30/04/2024 14/06/2024 https://clinicaltrials.gov/study/NCT06391918 Advanced/Metastatic Company N N N United States Multiple cancer types Any solid tumours Valganciclovir Safety and/or Dose Phase 1 DB00313 N
NCT05013450 Dupilumab_Metastatic NSCLC RECRUITING Metastatic Non-small Cell Lung Cancer DRUG: Dupilumab; DRUG: PD-1/PD-L1 blockade; DRUG: Anakinra Dose Limiting Toxicity (DLTs), Phase 1: Dose Limiting Toxicity (DLTs) as defined based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0., 9 weeks; Overall Response Rate (ORR), Phase 2: Overall response rate by imaging at time of first repeat imaging (\ 9w from the start of therapy) using standard response criteria (RECIST v1.126). ORR is defined as the combined percent of the patients experiencing a partial response (PR) or a complete response (CR) at time of first reimaging., 9 weeks Thomas Marron All ADULT, OLDER_ADULT 21 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT STUDY-21-00907 09/10/2021 12/01/2025 12/01/2026 19/08/2021 10/09/2024 https://clinicaltrials.gov/study/NCT05013450 Advanced/Metastatic; Recurrent/Refractory Hospital/University/Research Institute N Y N United States Lung Non-Small Cell Lung Cancer Anakinra Safety and/or Dose; Response rate; PFS; OS Phase 1/2 DB00026 N
NCT06241352 Statin Addition to Chemotherapy for Advanced Pancreatic Cancer RECRUITING Advanced Pancreatic Cancer DRUG: statin addition to chemotherapy Decrease rate of CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125), The proportion of patients with a decrease of over 20 in CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125) one month after the start of treatment., 1-2 month Changhai Hospital All ADULT, OLDER_ADULT 40 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT ChanghaiH-PP13 20/01/2024 12/01/2024 02/01/2027 02/05/2024 16/10/2024 https://clinicaltrials.gov/study/NCT06241352 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Pancreatic Cancer Atorvastatin Biomarker Phase 2 DB01076 N
NCT06327451 Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma RECRUITING Glioblastoma, IDH-wildtype DRUG: Atorvastatin 20mg progression-free survival, progression-free survival, the time from the start of GBM surgery to tumor progression (recurrence) or death, whichever came first, assessed up to 52 weeks; Overall survival, Overall survival, the time from the start of GBM surgery to the day of death from any cause, whichever came first, assessed up to 52 weeks; Tumor control rate, Tumor control rate, Changes in tumor size before and after treatment, assessed up to 52 weeks Tianjin Medical University General Hospital All ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT IRB2024-YX-037-01 04/01/2024 28/02/2026 28/02/2027 25/03/2024 25/03/2024 https://clinicaltrials.gov/study/NCT06327451 Localised/Locoregional Hospital/University/Research Institute N N N China CNS Glioblastoma Atorvastatin Response rate; PFS; OS Phase 2 DB01076 N
NCT06624371 Atovaquone Combined with Radiation in Children with Malignant Brain Tumors AflacBT2303 RECRUITING High-grade Glioma|Medulloblastoma|Diffuse Intrinsic Pontine Glioma|Diffuse Midline Glioma, H3 K27M-Mutant DRUG: Atovaquone; RADIATION: Radiation Therapy Drug Limiting toxicities (DLT) in Stratum 1, Adverse events that meet definition of DLT and tolerability. The outcome will be evaluated by descriptive statistics. Rates of symptomatic and asymptomatic radiation necrosis will also be estimated for Stratum 1 patients., Baseline, end of study (10 weeks); Drug Limiting toxicities (DLT) in Stratum 2, Adverse events that meet definition of DLT and tolerability. The outcome will be evaluated by descriptive statistics. Rates of symptomatic and asymptomatic radiation necrosis will also be estimated for Stratum 2 patients., Baseline, End of study (Month 7) Emory University All CHILD, ADULT 18 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00007693 01/01/2025 10/01/2027 10/01/2027 10/03/2024 11/07/2024 https://clinicaltrials.gov/study/NCT06624371 Localised/Locoregional Hospital/University/Research Institute N Y Y United States CNS Glioma Atovaquone Safety and/or Dose; PFS; Biomarker Phase 1 DB01117 N
NCT06518434 A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients CanHep RECRUITING Hepatocellular Carcinoma|Cannabis DRUG: Medical Cannabis Tumor size, Tumor size based on RECIST and mRECIST criteria, 9 months University Medical Center Groningen All ADULT, OLDER_ADULT 20 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 201800881 15/04/2021 15/04/2027 15/04/2027 24/07/2024 24/07/2024 https://clinicaltrials.gov/study/NCT06518434 Advanced/Metastatic Hospital/University/Research Institute N N N Netherlands GI Liver Cancer Cannabidiol Response rate Phase 2 DB09061 N
NCT06328387 HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer RECRUITING Advanced Breast Cancer|Metastatic Breast Cancer DRUG: Hydroxychloroquine; DRUG: Sacituzumab Govitecan; DRUG: Trastuzumab Deruxtecan Dose Limiting Toxicity, DLT, A dose limiting toxicity DLT is defined as any of the following-related adverse event(AE) that occurs during the DLT period, graded according to the NCI Common Terminology Criteria for Adverse Events(CTCAE), Version 5.0, 3 weeks; Adverse event, AE, Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment., 2 years; Objective Response Rate, ORR, the proportion of patients with a tumor volume reduction of 30 and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR)., 2 years Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Female ADULT, OLDER_ADULT 120 OTHER Interventional Study Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT SYSKY-2024-064-03 29/01/2024 02/01/2026 03/01/2026 25/03/2024 25/03/2024 https://clinicaltrials.gov/study/NCT06328387 Advanced/Metastatic Hospital/University/Research Institute Y Y N China Breast Any Breast Cancer Hydroxychloroquine Safety and/or Dose; Response rate Phase 1/2 DB01275 N
NCT06328686 Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases RECRUITING Metastatic Malignant Neoplasm in the Brain|Metastatic Malignant Solid Neoplasm DIETARY_SUPPLEMENT: Arginine; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging; PROCEDURE: Spectroscopy; RADIATION: Whole-Brain Radiotherapy Peak plasma L-arginine (arginine) and arginine metabolite concentration, By compartmental pharmacokinetic analysis, the plasma arginine levels at before administration, 10 min, 30 min, 1 hour, 2 hours, and 4 hours post administration will be used to estimate the median time to reach the peak plasma arginine and the mean value of peak. This will be done separately by two arms., Within 4 hours of oral and intravenous (IV) dosing of L-arginine Emory University All ADULT, OLDER_ADULT 10 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT STUDY00005787; NCI-2023-10895; STUDY00005787; WINSHIP5883-23; P30CA138292 09/05/2024 31/12/2025 31/12/2026 25/03/2024 19/09/2024 https://clinicaltrials.gov/study/NCT06328686 Advanced/Metastatic Hospital/University/Research Institute N Y N United States Multiple cancer types Multiple cancer types L-Arginine Safety and/or Dose; Biomarker Phase 1 DB00448 N
NCT06540937 Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor RECRUITING Neuroendocrine Tumors DRUG: Leflunomide Pill Overall response rate (ORR) assessed by RECIST 1.1, ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1., up to 36 weeks; Progression-free survival (PFS), PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause., up to 36 weeks Cancer Institute and Hospital, Chinese Academy of Medical Sciences All ADULT, OLDER_ADULT 50 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT NCC2409 07/01/2020 30/12/2024 30/12/2024 08/07/2024 08/07/2024 https://clinicaltrials.gov/study/NCT06540937 Localised/Locoregional Hospital/University/Research Institute N N N China Endocrine Neuroendocrine Tumours Leflunomide Response rate; PFS Phase 2 DB17289 N
NCT06454383 Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer RECRUITING Advanced Pancreatic Adenocarcinoma|Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8|Unresectable Pancreatic Ductal Adenocarcinoma PROCEDURE: Biospecimen Collection; DRUG: Cholestyramine; PROCEDURE: Computed Tomography; PROCEDURE: Diagnostic Imaging; DRUG: Gemcitabine; DRUG: Leflunomide; PROCEDURE: Magnetic Resonance Imaging Dose limiting toxicities (DLTs), Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0., Up to 28 days (cycle 1); Incidence of adverse events, Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0., Up to 30 days after completion of study treatment City of Hope Medical Center All ADULT, OLDER_ADULT 19 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 23540; NCI-2024-04359; 23540; P30CA033572 13/05/2024 13/11/2026 13/11/2026 06/12/2024 06/12/2024 https://clinicaltrials.gov/study/NCT06454383 Advanced/Metastatic Hospital/University/Research Institute N N N United States GI Pancreatic Cancer Leflunomide Safety and/or Dose; Response rate; OS Phase 1 DB17289 N
NCT06539806 Clinical Study Evaluating the Effect of Losartan RECRUITING Pancreatic Cancer DRUG: Losartan 50mg Tab the patient response rate, the patient response rate which will be measured using response evaluation criteria in solid tumors (RECIT 1.1)., one year Tanta University All ADULT, OLDER_ADULT 90 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT Mona Abd El-Rafea Mohamed 20/07/2024 08/10/2026 20/08/2026 08/06/2024 08/06/2024 https://clinicaltrials.gov/study/NCT06539806 Advanced/Metastatic Hospital/University/Research Institute Y Y N Egypt GI Pancreatic Cancer Losartan Response rate Not available/Missing DB00455 N
NCT06500234 Nutrition Impact on Immunotherapy of Cancer RECRUITING Nutrition Disorders|Immunotherapy|Cancer|Survival, Prosthesis DRUG: Megestrol Acetate and olanzapine; DRUG: Starch powder 50 mg ORR, overall response rate, 12 months Qingdao Central Hospital All ADULT, OLDER_ADULT 300 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT KY202400918 06/01/2024 31/05/2025 31/05/2027 15/07/2024 15/07/2024 https://clinicaltrials.gov/study/NCT06500234 Localised/Locoregional Hospital/University/Research Institute Y N N China Multiple cancer types Any solid tumours Megestrol Acetate; Olanzapine Response rate; PFS Phase 3 DB00358; DB05990 N
NCT06417736 Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women RECRUITING Endometrial Cancer Stage I|Endometrial Hyperplasia DRUG: Megestrol Acetate 40 MG 24-week complete response(CR) rate, The treatment response:complete response,no endometrial lesion, baseline,12 weeks after treatment,and 24 weeks of treatment Women's Hospital School Of Medicine Zhejiang University Female ADULT 75 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT PRO2023-3614 12/01/2023 31/07/2025 31/12/2026 16/05/2024 16/05/2024 https://clinicaltrials.gov/study/NCT06417736 Localised/Locoregional Hospital/University/Research Institute N N N China Gynaecological Endometrial Cancer Megestrol Acetate Response rate Not available/Missing DB00358 N
NCT06686043 HPV Vaccine, Imiquimod, and Metformin Combination Trial HPV-VIM RECRUITING Cervical Carcinoma|Vaginal Carcinoma|Vulvar Carcinoma|HPV (Human Papillomavirus)-Associated Carcinoma DRUG: HPV vaccine, Imiquimod, and metformin combination therapy Progression free survival, Progression-free survival at 24 months will be collected for all patients., 24 months Baylor College of Medicine Female ADULT 85 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT H-54674 23/08/2024 23/08/2026 23/08/2028 13/11/2024 13/11/2024 https://clinicaltrials.gov/study/NCT06686043 Advanced/Metastatic Hospital/University/Research Institute N N N United States Gynaecological Cervical Cancer; Vaginal Cancer; Vulvar Cancer Metformin PFS Phase 2 DB00244 N
NCT06537843 Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia VenCM RECRUITING Acute Myeloid Leukemia DRUG: Venetoclax; DRUG: Cytarabine Injection; DRUG: Metformin Overall Survival (OS), Overall survival is defined as the time from patient inclusion to the date of death, using Kaplan-Meier methodology., 12 months and 24 months Hospital Municipal S o Jos All ADULT, OLDER_ADULT 100 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT VenCM-001 12/01/2023 07/01/2026 07/01/2028 08/05/2024 08/05/2024 https://clinicaltrials.gov/study/NCT06537843 Recurrent/Refractory Hospital/University/Research Institute N N N Brazil Leukemia Acute Myeloid Leukemia, Adult Metformin OS Phase 2 DB00244 N
NCT06569368 A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy RECRUITING Rectal Adenocarcinoma DRUG: Metronidazole 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 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT 2023-0880 07/10/2024 31/10/2024 31/10/2026 26/08/2024 19/09/2024 https://clinicaltrials.gov/study/NCT06569368 Localised/Locoregional Hospital/University/Research Institute Y N N United States GI Rectal Cancer Metronidazole Safety and/or Dose Phase 2 DB01233 N
NCT06356597 Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial RECRUITING Colorectal Cancer DRUG: Tislelizumab with Fruquintinib, Metronidazole objective response rate, 3 months and 6 months Jing-yuan Fang, MD, Ph. D All ADULT, OLDER_ADULT 25 OTHER Interventional Study Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT KY2024-004-A 04/01/2024 12/12/2025 12/12/2027 04/10/2024 04/10/2024 https://clinicaltrials.gov/study/NCT06356597 Advanced/Metastatic Other N N N China GI Rectal Cancer; Colon Cancer Metronidazole Response rate Phase 2 DB01233 N
NCT06338683 Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer RECRUITING Advanced Cancer|Olanzapine|Progression Free Survival DRUG: Olanzapine 2.5 MG; DRUG: Standard anti-tumor treatment; DIETARY_SUPPLEMENT: Nutritional advice Comparing the difference in Median PFS between the two groups, PFS was defined as the time between the start of treatment in this study and the onset of (any aspect of) tumor progression or death (from any cause). Assessment through the RECICT 1.1 version of solid tumors, 2 years Qinghai Red Cross Hospital All ADULT, OLDER_ADULT 230 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT QRCH-2024001 20/03/2024 20/03/2027 20/03/2028 29/03/2024 29/03/2024 https://clinicaltrials.gov/study/NCT06338683 Advanced/Metastatic Hospital/University/Research Institute Y N N China Multiple cancer types Multiple cancer types Olanzapine PFS; OS Phase 3 DB05990 N
ChiCTR2400085250 A single-center, dose-escalation, and cohort-expanding single-arm, open-label Phase I/IIa clinical study evaluating the safety, tolerability, and initial efficacy of doxycycline in patients with intrahepatic cholangiocarcinoma that progresses after standard treatment Recruiting Advanced intrahepatic cholangiocarcinoma Experimental group (Phase I):This phase is a single-arm, open design and is intended to determine the MTD and/or RP2D of doxycycline by dose climbing (200mg/ day, 400mg/ day, 600mg/ day, 800mg/ day). Doxycycline: Continuous oral administration, twice a day, half a dose each time, 12 hours between the two times, after meals, or according to the previous low dose of PK/PD adjustment mode of administration. The 3+3 dose climbing principle was adopted, with the initial dose of 200mg/ day and the incremental dose of 400mg/ day, 600mg/ day and 800mg/ day. Whether to proceed to the next dose group test after completion of each dose group is determined according to the following rules: (1) If no dose limiting toxicity (DLT) occurs in all three patients, the next dose group is increased. (2) If DLT occurs in =2 patients, decrease to the previous dose group. (3) If 1 out of 3 patients developed DLT, 3 more patients were added to the dose group for testing. If 1/6 patients develop DLT, increase to the next dose group. If =2/6 patients develop DLT, decrease to the previous dose group. (4) When the dose is reduced to the previous dose group, if there are only 3 patients in this dose group, 3 more patients are added for the test. If this dose has been tested in 6 patients, the trial is over and this dose is the maximum tolerated dose (MTD).;Experimental group (Phase II):This stage is to preliminarly observe the efficacy of doxycycline in the treatment of patients with intrahepatic cholangiocarcinoma who are unresponsive or resistant to chemotherapy combined with PD-1 monoclonal antibody. RP2D was determined based on the safety, tolerability, and initial antitumor effects observed in the Phase I clinical trial, combined with the concentrations used in our team's previous in vitro c Safety;Tolerability;Maximum Tolerated Dose;Recommended Phase II Dose;Progression-Free Survival; The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital) All 18 - 75 Experimental group (Phase I):12;Experimental group (Phase II):38; National Natural Science Foundation of China Interventional Study Single arm 06/04/2024 06/04/2024 07/08/2024 https://www.chictr.org.cn/showproj.html?proj=232451 Advanced/Metastatic Hospital/University/Research Institute N N N China GI Cholangiocaricnoma Doxycycline Safety and/or Dose; PFS; OS; Biomarker Phase 1/2 DB00254 N
CTIS2022-502633-26-00 Does peri-operative treatment with Tranexamic Acid reduce the early relapse rate for patients with melanoma; a randomised controlled trial Recruiting MelanomaSurgery;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02];Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17];Therapeutic area: Diseases [C] - Neoplasms [C04] Product Name: Tablets Placebo, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Pilexam, injektionsv ske, opl sning, Product Code:PRD4067315, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: PLACEBO, Product Code:SUB21402, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Pharmaceutical form of the placebo: SOLUTION FOR INJECTION , Product Name: Cyklonova, filmovertrukne tabletter, Product Code:PRD454573, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: Tranexamic Acid , Strength: Main Objective: To test if perioperative treatment with TXA is superior to placebo and reduces the early relapse rates by >10 , for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery.;Secondary Objective: Evaluate safety and tolerability: defined as mild (abdominal pain, diarrhoea, or nausea) or severe (thromboembolic events) adverse effects., Evaluate postoperative complications: defined as bleeding, seroma formation, and infections within the first three postoperative months., Estimate melanoma specific survival probabilities and compare between the two treatment groups., From blood samples, at predefined timepoints, we monitor baseline and perioperative changes of factors associated with systemic inflammation, fibrinolysis, and metabolism, immune cell composition and activation status, and associate these factors with prognostic and treatment related outcomes., From tissue samples of the primary melanoma biopsy, local wide excisions and corresponding metastases, we will conduct fluorescence multiplex stainings and spatial transcriptomic, and analyse markers of the plasminogen-plasmin pathway, inflammation, and metabolism, and evaluate their roles as prognostic and predictive biomarkers.;Primary end point(s): Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome. Aarhus University Hospital Female 18 - 65+ 1204 Danish Cancer Society, ACROBATIC (Dansk Forskningscenter for Kr ftkirurgi), NEYE fonden 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: 25/08/2023 30/11/2022 22/07/2024 https://euclinicaltrials.eu//search-for-clinical-trials/?lang=en EUCT=2022-502633-26-00 Localised/Locoregional Hospital/University/Research Institute Y N N Denmark Skin Melanoma Tranexamic Acid Safety and/or Dose; Response rate; PFS; DFS/RFS/EFS; Biomarker Phase 3 DB07615 N
CTIS2022-500307-49-00 AMUM trial -Adjuvant Melatonin for Uveal Melanoma: A randomized open Phase III Study Recruiting uveal melanoma
MedDRA version: 21.1Level: PTClassification code: 10081431Term: Uveal melanoma Class: 100000004864;Therapeutic area: Diseases [C] - Eye Diseases [C11];MedDRA version: 21.1Level: PTClassification code: 10081431Term: Uveal melanoma Class: 100000004864 Product Name: Melatonin AGB 5 mg tabletter, Product Code:PRD8253623, Pharmaceutical Form: TABLET, Other descriptive name: , Strength: Main Objective: Kan adjuvant behandling med 20 mg melatonin varje kv ll i 5 r minska f rekomsten av metastaser av uvealt melanom p 5 rs sikt?;Secondary Objective: Kan adjuvant behandling med 20 mg melatonin varje kv ll i fem r f rb ttra totalo verlevnad p 5 rs sikt?, Kan adjuvant behandling med 20 mg melatonin varje kv ll i fem r minska risken att utveckla annan cancer p 5 rs sikt?, Kan adjuvant behandling med 20 mg melatonin varje kv ll i fem r f rb ttra total verlevnad efter uppt ckt av metastaser?, Kan adjuvant behandling med 20 mg melatonin varje kv ll i fem r visa om f rekomsten av AE och SAE skiljer sig t i melatonin- och kontrollgrupp?;Primary end point(s): Andel forskningspersoner som r fria fr n metastaser 5 r efter randomisering i melatonin- respektive kontrollarm (relativ risk) St Erik Eye Hospital Female 18 - 65+ 100 The Crown Princess Margareta Foundation for the Visually Impaired;Region Stockholm;The Royal Swedish Academy of Sciences;The Swedish Society of Medicine (Cronqvists stiftelse);The Swedish Eye Foundation;The Swedish Cancer Society 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: 03/10/2022 29/03/2022 22/07/2024 https://euclinicaltrials.eu//search-for-clinical-trials/?lang=en EUCT=2022-500307-49-00 Localised/Locoregional Hospital/University/Research Institute Y N N Sweden Ocular Melanoma - Intraocular Melatonin OS; Recurrence rate Phase 3 DB00351 N
CTIS2023-504191-26-00 DICIT: Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial Recruiting Metastatic Melanoma
MedDRA version: 21.1Level: PTClassification code: 10027480Term: Metastatic malignant melanoma Class: 100000004864;Therapeutic area: Diseases [C] - Neoplasms [C04];Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] Product Name: , Product Code:SCP8265340, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: Diclo 50 - 1 A Pharma 50 mg magensaftresistente Tabletten, Product Code:PRD783773, Pharmaceutical Form: GASTRO-RESISTANT TABLET, Other descriptive name: , Strength: , Product Name: Pantoprazol TAD 20 mg magensaftresistente Tabletten, Product Code:PRD454068, Pharmaceutical Form: GASTRO-RESISTANT TABLET, Other descriptive name: , Strength: , Product Name: Diclofenac AL 25 Diclofenac-Natrium 25 mg pro magensaftresistente Tablette, Product Code:PRD1968919, Pharmaceutical Form: GASTRO-RESISTANT TABLET, Other descriptive name: , Strength: , Product Name: , Product Code:SCP6094344, Pharmaceutical Form: , Other descriptive name: , Strength: Main Objective: To evaluate the efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved SD as best response in metastatic melanoma patients.;Secondary Objective: Not applicable;Primary end point(s): Objective response (OR) at week 9 (visit3/day64+5days), defined as a confirmed best response of either a complete response (CR) or a partial response (PR), as determined by investigator assessment using positron emission tomography in combination with computed tomography with contrast agent (diagnostic-quality PET-CT) according to the Response Evaluation Criteria in Solid Tumor, version 1.1 (RECIST 1.1.). Universitaetsklinikum Regensburg Female 18 - 65+ 48 Deutsche Krebshilfe 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: 20/09/2024 28/11/2023 21/10/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2023-504191-26-00 Advanced/Metastatic Hospital/University/Research Institute N N N Germany Skin Melanoma Diclofenac Response rate; Biomarker Phase 2/3 DB00586 N
CTIS2022-502524-41-00 A window-of-opportunity trial with high-dose vitamin C to enhance neoadjuvant immune checkpoint therapy in mismatch repair proficient colorectal cancer: the ALFEO pilot study Recruiting pMMR/MSS, Colon Cancer
MedDRA version: 21.0Level: PTClassification code: 10009955Term: Colon cancer stage III Class: 100000004864
MedDRA version: 21.0Level: PTClassification code: 10009956Term: Colon cancer stage IV Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10009944Term: Colon cancer Class: 100000004864
MedDRA version: 21.0Level: PTClassification code: 10009954Term: Colon cancer stage II Class: 100000004864;Therapeutic area: Diseases [C] - Neoplasms [C04] Product Name: OPDIVO 10 mg/mL concentrate for solution for infusion., Product Code:PRD2941372, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: YERVOY 5 mg/ml concentrate for solution for infusion, Product Code:PRD2341715, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: ASCORBIC ACID, Product Code:SUB05579MIG, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: Main Objective: To assess the activity of Ipilimumab + Nivolumab + high dose Vitamin C in a pre-operative setting in colorectal cancer;Secondary Objective: Safety and feasibility;Primary end point(s): Pathological response rate ASST Grande Ospedale Metropolitano Niguarda Female 18 - 65+ 24 Fondazione Oncologia Niguarda;Ministero della Salute - PNRR-MAD-2022-12376593 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: 21/05/2023 22/11/2022 21/08/2024 https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en EUCT=2022-502524-41-00 Localised/Locoregional Hospital/University/Research Institute N N N Italy GI Colon Cancer Ascorbic acid Response rate Phase 2 DB00126 N
IRCT20240923063132N1 Efficacy and safety of sodium valproate in treatment of Acute myeloid leukemia Recruiting Acute myeloid leukemia.
Acute myeloblastic leukemia;C92.0 Intervention 1: Intervention group: sodium valproate drug with a dose of 200 mg three times a day from the first day to the 21st day of treatment to the 3+7 regimen (7 days of cytarabine with a dose of 100-200 mg per square meter of body surface based on functional status and the patients age is determined along with 3 days of anthracyclines, including idarubicin 12 mg per square meter of body surface or daunorubicin 45-90 mg per square meter of body surface, according to the difference in drug availability) is added. Intervention 2: Control group: 3+7 chemotherapy regimen alone (7 days of cytarabine with a dose of 100-200 mg per square meter of body surface, which is determined based on the functional status and age of the patient, along with 3 days of anthracyclines including idarubicin 12 mg gram per square meter of body surface or daunorubicin 45-90 mg per square meter of body surface according to the difference in drug availability. Percentage and time to reach complete remission (CR). Timepoint: Daily CBC and bone marrow biopsy on day 14 to 21 of treatment cycle. Method of measurement: The presence of less than 5 blasts in the bone marrow sample in the bone marrow biopsy between days 14 and 21 and the absence of blasts in the peripheral blood along with the number of neutrophils more than 1500 per microliter and platelets more than 100,000 per microliter.;The rate of febrile neutropenia. Timepoint: Vital signs chart every 6 hours including body temperature and daily blood cell count test. Method of measurement: Measurement of body temperature by thermometer and daily evaluation of the absolute neutrophil count (ANC) in the laboratory. Shahid Beheshti University of Medical Sciences All 18 years - no limit 22 Shahid Beheshti University of Medical Sciences Interventional Study Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done in a non-random, easy way (available samples) and the classification of samples to be assigned to treatment groups will be done in a random block manner. The randomization unit is considered individual. RAS statistical software will be a tool for block randomization and also for determining the sequence of blocks. The sealed cover letter will be used for allocation concealment. 22/08/2024 10/06/2024 14/10/2024 http://irct.behdasht.gov.ir/trial/79319 Localised/Locoregional Hospital/University/Research Institute Y N N Iran Leukemia Acute Myeloid Leukemia, Adult Valproic Acid Response rate Phase 2/3 DB00177 N
NCT04705909 Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer UNKNOWN Breast Cancer DRUG: Pitavastatin; DRUG: placebo clinical response rate, Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50 decrease in the size of the primary tumor without appearance of new lesions., 6 months; Relative reduction of Ki67 in tumor samples, It will be described as average pre-post differences in percent positive cells with 95 Wilson confidence intervals., 6 months Mansoura University Female ADULT, OLDER_ADULT 60 OTHER Interventional Study Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT 2020 - 176 15/01/2021 15/09/2021 15/12/2021 01/12/2021 01/12/2021 https://clinicaltrials.gov/study/NCT04705909 Advanced/Metastatic Hospital/University/Research Institute Y N Y Egypt Breast Any Breast Cancer Pitavastatin Response rate Phase 2/3 DB00554 N