Clinical trialPhase 1Terminated
CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
A Phase I Dose-Escalation Study of CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
- Outcome
- Stopped earlyThe pharmaceutical funder pulled funding and no longer plans to develop the drug further. (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 31 October 2022
- Expected end
- 8 July 2025
- Enrollment
- 8 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose of CPI-613®
- Sponsor
- Other
- Results posted
- No
- Last update
- 12 November 2025
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Source text
Brief summary public domain (ClinicalTrials.gov)
This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).
Detailed description public domain (ClinicalTrials.gov)
This study is designed to test the hypothesis that a combination of gemcitabine and radiation therapy (Gem-RT) with CPI-613®, a selective mitochondrial metabolism inhibitor in PDAC tumor cells, will be well tolerated without additional significant toxicity. Additionally, CPI-613® is expected to improve the Gem-RT effectiveness, resulting in durable local control of disease. As a necessary and initial step to translate preclinical observations into a patient setting and test our proposed hypotheses, the investigators will perform a dose-finding phase I clinical trial that has been designed to evaluate the maximum tolerated dose (MTD), recommended phase II dose (RP2D), and safety profile of CPI-613® along with standard of care Gem-RT in patients with unresectable PDAC in need of definitive local control of disease. The overarching goals for this trial are to determine the safety and toxicity of CPI-613® when given concurrently with Gem-RT.