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

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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
9
sites
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Aurora, CO
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Ann Arbor, MI
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3 Doherty Street
Birtinya, 4575
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Birtinya,
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609 North Charles Richard Beall Boulevard
DeBary, Florida 32713
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mi
from
DeBary, FL
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3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
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mi
from
Fayetteville, AR
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600 Highland Avenue
Madison, Wisconsin 53792
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mi
from
Madison, WI
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1301 Medical Center Drive
Nashville, Tennessee 37232
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mi
from
Nashville, TN
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Philadelphia, Pennsylvania 19107
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mi
from
Philadelphia, PA
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
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mi
from
Phoenix, AZ
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