drugset / Trial / NCT03374852
CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
Phase 2
Withdrawn
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Cornerstone Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single arm, phase II trial, of 45 patients with locally advanced pancreatic ductal adenocarcinoma. The efficacy of the novel drug and mitochondrial inhibitor, CPI-613, in conjunction with standard-of-care FOLFRINOX, as a first-line therapy will be evaluated. Pre-treatment, diagnostic biopsy tissue will be collected when available, and clinical data will be evaluated to determine if the combination results in improved overall survival compared to historical experience.
Timeline
- Start
- 2018-08
- Primary completion
- 2019-10-05
- Completion
- 2020-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPI-613 | Small molecule | 500 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 65 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |