7 withdrawn, 4 terminated, 3 completed, 1 unknown. 8 Phase 2, 6 Phase 1, 2 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Withdrawn 5, Terminated 2, Completed 1 |
| Phase 1 | 6 | Completed 2, Terminated 2, Unknown 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Not applicable | 1 | Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) CPI 613, Metformin, Blood draws - Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory | Phase 2 | Withdrawn | Wake Forest University Health Sciences | 2024-12-01 | 2024-09-19 | |
| Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer CPI-613, modified Folfirinox - Pancreatic Cancer Stage IV | Phase 2 | Withdrawn | Cornerstone Pharmaceuticals | 2024-08-15 | 2024-08-15 | |
| CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer CPI-613, modified FFX, Bevacizumab - C04.588.274.476.411.307 | Phase 1 | Withdrawn | Cornerstone Pharmaceuticals | 2023-03-30 | 2023-09-13 | |
| CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma CPI-613® (Dose level -1.0 250 mg/m^2), CPI-613® (Dose level 1.0 500 mg/m^2), CPI-613® (Dose level 2.0 1,000 mg/m^2) - Pancreas Adenocarcinoma | Phase 1 | Terminated | Medical College of Wisconsin | 8 | 2022-10-31 | 2025-11-12 |
| To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613® (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue CPI-613 + Hydroxychloroquine - Sarcoma, Clear Cell | Phase 1 / Phase 2 | Completed | Cornerstone Pharmaceuticals | 16 | 2021-09-01 | 2023-05-24 |
| Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML CPI-613 + High Dose Cytarabine and Mitoxantrone, High Dose Cytarabine and Mitoxantrone, Mitoxantrone, Etoposide and Cytarabine - Relapsed/Refractory Acute Myeloid Leukemia | Phase 3 | Terminated | Cornerstone Pharmaceuticals | 200 | 2018-11-12 | 2023-02-08 |
| Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas CPI 613, mFolfirinox, Folfirinox - Pancreatic Cancer Metastatic | Phase 3 | Completed | Cornerstone Pharmaceuticals | 528 | 2018-11-09 | 2023-01-03 |
| CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer CPI-613, mFOLFIRNOX - Pancreatic Ductal Adenocarcinoma | Phase 2 | Withdrawn | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 2018-08-01 | 2025-04-29 | |
| A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With Advanced or Metastatic Pancreatic Cancer CPI 613 in Combination With Gemcitabine and Nab-paclitaxel - Pancreatic Cancer, Metastatic Pancreatic Cancer | Phase 1 | Unknown | Atlantic Health System | 24 | 2017-10-19 | 2018-02-19 |
| Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome CPI-613 - Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) | Phase 2 | Withdrawn | Cornerstone Pharmaceuticals | 2016-01-01 | 2016-12-29 | |
| Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer CPI-613, Gemcitabine, Any non-gemcitabine chemotherapies or best supportive care - Metastatic Pancreatic Adenocarcinoma | Phase 2 | Withdrawn | Cornerstone Pharmaceuticals | 2014-01-01 | 2013-08-14 | |
| Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients CPI-613 - Cancer | Phase 2 | Terminated | Cornerstone Pharmaceuticals | 7 | 2013-06-01 | 2016-12-29 |
| Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome Curosurf®, Survanta® - Respiratory Distress Syndrome | Not applicable | Withdrawn | University of Michigan | 2012-06-01 | 2014-01-08 | |
| A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients CPI-613, Gemcitabine - Cancer, Pancreatic Cancer | Phase 1 / Phase 2 | Terminated | Cornerstone Pharmaceuticals | 6 | 2009-05-01 | 2017-03-21 |
| A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies CPI-613 - Advanced Cancer, Metastatic Cancer | Phase 1 | Completed | Cornerstone Pharmaceuticals | 39 | 2008-08-01 | 2016-12-29 |
Neoplasms (4) · Leukemia, Myeloid, Acute (3) · Neoplasm Metastasis (3) · Pancreatic Neoplasms (3) · Recurrence (2) · Adenocarcinoma (1) · Breast Neoplasms (1) · Carcinoma, Hepatocellular (1) · Colonic Neoplasms (1) · Esophageal Neoplasms (1) · Lung Neoplasms (1) · Lymphoma (1) · Myelodysplastic Syndromes (1) · Respiratory Distress Syndrome (1) · Sarcoma, Clear Cell (1)
devimistat (14) · Gemcitabine (4) · 130-nm albumin-bound paclitaxel (1) · Albumin-Bound Paclitaxel (1) · Bevacizumab (1) · Blood Specimen Collection (1) · Cytarabine (1) · Etoposide (1) · Filgrastim (1) · Hydroxychloroquine (1) · Irinotecan (1) · Leucovorin (1) · Metformin (1) · Mitoxantrone (1) · Oxaliplatin (1)
United States (12) · Belgium (2) · France (2) · Germany (2) · South Korea (2) · Australia (1) · Austria (1) · Canada (1) · Israel (1) · Poland (1) · Spain (1)
King C Lee, Ph.D. (3) · Avi Retter, M.D. (2) · Angela T Alistar, MD (1) · Bayard Powell, MD (1) · Divis K Khaira, M.D. (1) · Jordan Winter, MD (1) · Jorge E Cortes, MD (1) · Karen Gelmon, M.D. (1) · Mandana Kamgar, MD, MPH (1) · Neil Senzer, M.D. (1) · Philip A Philip, MD, PhD, FRCP (1) · Senzer Neil, M.D. (1) · Steven Donn, M.D. (1)
PMID 37678921, PMID 31512497, PMID 36479231, PMID 39088774, PMID 40454396
P30CA012197 (1)