Clinical trialPhase 2Withdrawn
CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status
- Outcome
- Stopped earlyPI Left institution on 8/6/2018 and study has been final reported with IRB. Never opened to accrual (Other)
- Phase
- Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- August 2018
- Expected end
- October 2020
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Overall Survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 29 April 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Primary Objective: 1\) To determine if CPI-613 increases overall survival (OS) when used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer. Secondary (Exploratory) Objectives: 1. To assess the safety of CPI-613 + mFOLFIRINOX combination in patients with locally advanced pancreatic cancer. 2. To collect tissue specimens for future correlative studies 3. To estimate median progression free survival (PFS) when CPI- 613 is used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer. 4. To estimate the percent resected when CPI-613 is used in combination with mFOLFIRINOX in patients with locally advanced pancreatic cancer