Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Condition: Untreated Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Veliparib; Placebo; Modified FOLFIRI; FOLFIRI; Bevacizumab; Fluorouracil infusion
Intervention description: 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; 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; 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; 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; At the discretion of the Investigator, 5 mg/kg may be administered intravenously immediately preceding FOLFIRI dosing; 2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle
Intervention MeSH terms: Bevacizumab; Fluorouracil; Veliparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: PARP inhibitor; veliparib; metastatic colorectal cancer; ABT-888; first line; previously untreated; colorectal cancer; colon cancer; rectal cancer; FOLFIRI; fluorouracil; 5-FU; leucovorin; irinotecan

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.
    

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