Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Untreated Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Untreated Metastatic Colorectal Cancer focused on measuring PARP inhibitor, veliparib, metastatic colorectal cancer, ABT-888, first line, previously untreated, colorectal cancer, colon cancer, rectal cancer, FOLFIRI, fluorouracil, 5-FU, leucovorin, irinotecan
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Veliparib + modified FOLFIRI ± bevacizumab
Placebo + FOLFIRI ± bevacizumab
Dosing of oral veliparib (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Modified FOLFIRI was administered as 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) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle.
Dosing of oral placebo (200 mg) began 2 days prior to the start of FOLFIRI and continued twice a day (BID) for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab (5 mg/kg) could be administered intravenously (IV) immediately preceding FOLFIRI. Standard FOLFIRI was administered as 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) immediately followed by fluorouracil 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) on Day 1 of each 14-day cycle.