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

Status:	Completed
Conditions:	Colorectal Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - 99
Updated:	9/28/2017
Start Date:	December 2, 2014
End Date:	September 21, 2017

Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab in Previously Untreated Metastatic Colorectal Cancer

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.

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

We found this trial at

sites

University of Michigan Medical Center /ID# 132774

Ann Arbor, Michigan 48109

from

Ann Arbor, MI