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Veliparib plus FOLFIRI in untreated metastatic colorectal cancer
NCT02305758Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2014
- Primary completion
- Sep 2017
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- veliparib
- Conditions
- metastatic colorectal cancer (mCRC)
01
Overview
Phase 2, randomised, double-blind trial in metastatic colorectal cancer (mCRC) comparing Veliparib Arm with Placebo Arm (2 arms). Primary endpoint: Progression-Free Survival up to 579 days. Started Dec 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Veliparib Arm
Veliparib + Modified FOLFIRI ± Bevacizumab
Placebo Arm
Placebo + Standard FOLFIRI ± Bevacizumab
03
Who it enrols
Patients with histologically confirmed metastatic adenocarcinoma of the colon or rectum, ECOG 0-1, and no prior anti-cancer treatment for metastatic disease.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
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