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Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

NCT03504423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2023-01-03

Study results available
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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

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

Sponsors & Collaborators

  • Cornerstone Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Philip A Philip, MD, PhD, FRCP · Karmanos Cancer Institute at Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2021-08-16
Completion
2022-01-02
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Israel
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504423 on ClinicalTrials.gov