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

PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

December 2, 2014

Primary Completion Date

September 22, 2017

Study Completion Date

September 22, 2017

Conditions
Untreated Metastatic Colorectal Cancer
Interventions
DRUG

Veliparib

200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days

DRUG

Placebo

200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days

DRUG

Modified FOLFIRI

Irinotecan 180 mg/m\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) on Day 1 of each 14-day cycle

DRUG

FOLFIRI

Irinotecan 180 mg/m\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\^2 (up to 15-minute infusion) on Day 1 of each 14-day cycle

DRUG

Bevacizumab

At the discretion of the Investigator, 5 mg/kg may be administered intravenously immediately preceding FOLFIRI dosing

DRUG

Fluorouracil infusion

2400 mg/m\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY