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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ramesh Ramanathan, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

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

International patient clinical studies questions