Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
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
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
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