NCT03504423

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Cornerstone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer Metastatic

Interventions

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

Timeline

• Start date: 2018-11-09
• Primary completion: 2021-08-16
• Completion: 2022-01-02
• First posted: 2018-04-20
• Last updated: 2023-01-03
• Results posted: 2023-01-03

Locations

74 sites across 6 countries: United States, Belgium, France, Germany, Israel, South Korea

Regulatory

• FDA-regulated drug study