Status:
COMPLETED
Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
Lead Sponsor:
AbbVie
Conditions:
Untreated Metastatic Colorectal Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 (F...
Detailed Description
Participants were randomized to one of 2 groups: veliparib plus FOLFIRI ± bevacizumab (veliparib group) or placebo plus FOLFIRI ± bevacizumab (placebo group), and stratified by planned use of bevacizu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02305758
Start Date
December 2 2014
End Date
September 22 2017
Last Update
November 20 2018
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