NCT03374852

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	CPI-613	500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port
DRUG	mFOLFIRNOX	mFOLFIRNOX (given immediately after CPI-613 administration):

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-10-05
• Completion: 2020-10-01
• First posted: 2017-12-15
• Last updated: 2025-04-29

Regulatory

• FDA-regulated drug study