Status:
COMPLETED
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Lead Sponsor:
AstraZeneca
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whethe...
Eligibility Criteria
Inclusion
- Patients will have measurable disseminated colorectal cancer that is incurable by surgery
- Patients will have had tumor progression following standard combination front-line or second-line chemotherapy.
- CRC patients who have relapsed or recurrent disease within six months after completing adjuvant or neoadjuvant chemotherapy
Exclusion
- Previous treatment with PARP inhibitors, including olaparib.
- Patients with symptomatic, uncontrolled brain metastases.
- Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
- Patients who are unable to swallow orally administered medication.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00912743
Start Date
May 1 2009
End Date
March 1 2012
Last Update
November 9 2016
Active Locations (8)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Palm Springs, California, United States
3
Research Site
Aurora, Colorado, United States
4
Research Site
Newark, Delaware, United States