Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2017-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This was a blinded, randomized, placebo-controlled Phase 2 multicenter study evaluating the efficacy and tolerability of veliparib plus irinotecan, fluorouracil, and leucovorin chemotherapy regimen (FOLFIRI) compared to placebo plus FOLFIRI in participants with previously untreated metastatic colorectal cancer. Participants could also have been treated with bevacizumab at the discretion of the Investigator.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Bevacizumab; Fluorouracil; Veliparib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum

• At least 1 unresectable lesion on a CT (Computerized Tomography) scan that is measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1

• ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1

• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Prior anti-cancer treatment for metastatic colorectal cancer

• Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors

• The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to Cycle 1 Day -2

• Any clinically significant and uncontrolled major medical condition

• Participant is pregnant or lactating

• Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities

• For those receiving bevacizumab, standard medical exclusionary conditions apply