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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port
mFOLFIRNOX (given immediately after CPI-613 administration):
Overall Survival
Overall survival defined as the interval between enrollment and death.
Time frame: Enrollment to death
Progression free survival (PFS)
Progression free survival time is defined as time from enrollment until progression or death. The distribution of PFS will be estimated using the Kaplan-Meier method.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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