NCT03374852

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

Withdrawn Phase 2 Last updated 28 April 2025

What this trial tests

Phase 2 trial testing CPI-613 in Pancreatic Ductal Adenocarcinoma. Withdrawn.

Timeline

1 August 2018

Primary endpoint
5 October 2019

1 October 2020

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 August 2018
Primary completion	5 October 2019
Estimated completion	1 October 2020

Drugs / interventions tested

• CPI-613
• mFOLFIRNOX — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

Adults 18 to 80, any sex, with Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Survival
  Time frame: Enrollment to death
  Overall survival defined as the interval between enrollment and death.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial metabolism and cancer therapeutic innovation.
   Du H, Xu T, Yu S, Wu S, et al · · 2025 · cited 43× · PMID 40754534 · DOI 10.1038/s41392-025-02311-x
2. Combining PEGylated mito-atovaquone with MCT and Krebs cycle redox inhibitors as a potential strategy to abrogate tumor cell proliferation.
   Cheng G, Hardy M, You M, Kalyanaraman B. · · 2022 · cited 14× · PMID 35332210 · DOI 10.1038/s41598-022-08984-6
3. α-Ketoglutarate-Mediated DNA Demethylation Sustains T-Acute Lymphoblastic Leukemia upon TCA Cycle Targeting.
   Wang Y, Shen N, Spurlin G, Korm S, et al · · 2022 · cited 9× · PMID 35740646 · DOI 10.3390/cancers14122983
4. Metabolic Pathways as a Novel Landscape in Pancreatic Ductal Adenocarcinoma.
   Ali A, Chianese U, Papulino C, Toraldo A, et al · · 2022 · cited 8× · PMID 35954462 · DOI 10.3390/cancers14153799
5. Decoding Drug Resistance in Pancreatic Cancer: A Subcellular Structure Perspective.
   Li X, Lyu H, Wu Y, Chen A, et al · · 2026 · PMID 41972577 · DOI 10.3390/biology15070574