Efficacy and Safety of olaparib in Pretreated Patients with Measurable Colorectal Cancer, stratified by microsatellite instability (MSI) status
Study identifier:D9010C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase II, Open-Label, Multicenter Trial to Assess the Efficacy and Safety of the PARP inhibitor, olaparib, Alone in Previously-Treated Patients with Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status
Medical condition
Colorectal Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
olaparib
Sex
All
Actual Enrollment
33
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 May 2009
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 Mar 2012
Study design
Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 MSI - H arm | Drug: olaparib 400 mg po bid continuously |
Contacts
Investigators
Principal Investigator
Lawrence P Leichman
Aptium Oncology Gastrointestinal Cancer Consortium (AGICC).
