drugset
drugset / Trial / NCT02305758

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

NCT02305758 ↗

Phase 2 Completed 130 enrolled AbbVie
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-12-02
Primary completion
2017-09-22
Completion
2017-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Veliparib Small molecule 200 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 —
Background Leucovorin Small molecule 400 mg/m2 —
Background fluorouracil Small molecule 400 mg/m2 —
Background fluorouracil Small molecule 2400 mg/m2 —

Indications

colorectal cancer