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A Phase I Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer and Good Performance Status
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.
Details
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2013-04 |
| Completion | 2023-03-16 |
Conditions
- Acinar Cell Adenocarcinoma of the Pancreas
- Duct Cell Adenocarcinoma of the Pancreas
- Recurrent Pancreatic Cancer
- Stage IV Pancreatic Cancer
Interventions
- 6,8-bis(benzylthio)octanoic acid
- oxaliplatin
- leucovorin calcium
- irinotecan hydrochloride
- fluorouracil
- laboratory biomarker analysis
Primary outcomes
- Maximum Tolerated Dose — 2 weeks
of 6,8-bis(benzylthio)octanoic acid when used in combination with mFOLFIRINOX determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Countries
United States