Clinical trialPhase 3Completed
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 9 November 2018
- Expected end
- 2 January 2022
- Enrollment
- 528 participants
- Sites
- 74
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Industry
- Results posted
- 2023-01-03
- Last update
- 3 January 2023
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Brief summary public domain (ClinicalTrials.gov)
A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [38 months]. Median, months (95% Confidence Interval). CPI-613, mFolfirinox (n=266): 11.10 (10.22 to 12.94); Folfirinox (n=262): 11.73 (10.12 to 13.24).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [38 months]. Median, months (95% Confidence Interval). CPI-613, mFolfirinox (n=266): 7.82 (6.97 to 10.91); Folfirinox (n=262): 7.98 (7.23 to 11.14).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [38 months]. Count Of Participants, Participants. CPI-613, mFolfirinox (n=266): 104; Folfirinox (n=262): 90.
Papers 3
- Registry-listed results paperDevimistat (CPI-613) With Modified Fluorouarcil, Oxaliplatin, Irinotecan, and Leucovorin (FFX) Versus FFX for Patients … DOI 10.1200/jco.23.02659↗
- Builds on itInhibition of TCA cycle improves the anti-PD-1 immunotherapy efficacy in melanoma cells via ATF3-mediated PD-L1 express… DOI 10.1136/jitc-2023-007146↗
- Builds on itA Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRIN… DOI 10.2217/fon-2019-0209↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.