drugset / Trial / NCT01835041
CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer
Phase 1
Completed
21 enrolled
Wake Forest University Health Sciences
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects and best dose of CPI-613 when given together with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Timeline
- Start
- 2013-04
- Primary completion
- 2017-02-28
- Completion
- 2023-03-16
Publications
- Liu N, Yan M, Tao Q, Wu J, Chen J, Chen X, Peng C. Inhibition of TCA cycle improves the anti-PD-1 immunotherapy efficacy in melanoma cells via ATF3-mediated PD-L1 expression and glycolysis. J Immunother Cancer. 2023 Sep;11(9):e007146. doi: 10.1136/jitc-2023-007146.
- Alistar A, Morris BB, Desnoyer R, Klepin HD, Hosseinzadeh K, Clark C, Cameron A, Leyendecker J, D'Agostino R Jr, Topaloglu U, Boteju LW, Boteju AR, Shorr R, Zachar Z, Bingham PM, Ahmed T, Crane S, Shah R, Migliano JJ, Pardee TS, Miller L, Hawkins G, Jin G, Zhang W, Pasche B. Safety and tolerability of the first-in-class agent CPI-613 in combination with modified FOLFIRINOX in patients with metastatic pancreatic cancer: a single-centre, open-label, dose-escalation, phase 1 trial. Lancet Oncol. 2017 Jun;18(6):770-778. doi: 10.1016/S1470-2045(17)30314-5. Epub 2017 May 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPI-613 | Small molecule | 500 mg/m2 | Intravenous |
| Subject | CPI-613 | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 65 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |