09CRC01 Study Summary
PROTOCOL SUMMARY:
Title:
A Phase II, Open-Label, Multicenter Trial to Assess the Efficacy and Safety of a PARP Inhibitor Alone in Previously Treated Patients with Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status.
Primary Objective:
To determine the response rate of the investigational PARP inhibitor in patients with advanced CRC who have progressed or failed to respond following standard combination therapy (or therapies) for CRC.
Secondary Objectives:
To determine the safety, tolerability, and toxicities of the PARP inhibitor in patients previously treated for advanced CRC.
To estimate the progression free survival for previously treated patients with advanced CRC.
To calculate the overall survival for previously treated patients with advanced CRC.
Exploratory Translational Objectives:
To determine whether PARP-1 levels found in archival tissue prior to biopsy have a relationship to response and/or toxicity for patients treated with a PARP-1 inhibitor.
To measure and explain drug activity levels after 7 to 10 days of therapy with a PARP-1 inhibitor.
Target Population:
Patients with advanced, previously treated metastatic colorectal cancer with and without mismatch repair genes (MSI-H and non-MSI-H).
Enrollment Period:
May 2009 to December 2010.
Study Contact Information:
General AGICC contact:
Patricia Ames: (323) 966-3564
See www.clinicaltrials.gov trial identifier: NCT00912743.
This clinical research trial is enrolling patients at all AGICC sites.
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