At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 528 enrolled
Drug / intervention
CPI 613, mFolfirinox +1 moredrug
Likely dose
CPI 613, mFolfirinox 500mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CPI 613, mFolfirinox and Folfirinox for Pancreatic Cancer Metastatic. Completed, enrolled 528 participants across 74 sites in 6 countries.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer Metastatic
CountriesBelgium, France, Germany, Israel, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartNov 2018
Primary CompletionAug 2021
Study CompletionJan 2022
TodayJul 2026
First PostedApr 20, 2018
Enrollment StartNov 9, 2018
Primary CompletionAug 16, 2021
Study CompletionJan 2, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.2 years ago
Interventions
CPI 613, mFolfirinoxdrug
CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration
Folfirinoxdrug
Folfirinox