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

Study Identifier
M14-217
CT.gov Identifier
NCT02305758
EudraCT Identifier
2014-002866-65
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Study Details

Medical Condition
  • Colorectal Cancer
    • Study Drug
  • Veliparib
  • Placebo
  • Modified FOLFIRI
  • FOLFIRI
  • Bevacizumab
  • Fluorouracil infusion
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    No locations found.