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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 14-008514
    NCT ID: NCT02305758
    Sponsor Protocol Number: M14-217

About this study

This study seeks to evaluate the efficacy and tolerability of veliparib in combination with FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan. This is a blinded study such that the Investigator and Subject will be blinded but AbbVie will be unblinded.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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 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 colorectal cancer recurrence
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ramesh Ramanathan, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions