Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT00912743
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- olaparib — DRUG400 mg po bid continuously
Study Details
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 whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.
Key Dates
- Start date
- May 31, 2009
- Status verified
- Sep 2016
- Primary completion
- Mar 31, 2012
- Completion
- Mar 31, 2012
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1MSI - H arm
Primary Outcome Measure
Tumour Response [ Time Frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Los Angeles | California | - | - |
| Research Site | Palm Springs | California | - | - |
| Research Site | Aurora | Colorado | - | - |
| Research Site | Newark | Delaware | - | - |
| Research Site | New York | New York | - | - |
| Research Site | Philadelphia | Pennsylvania | - | - |
| Research Site | Nashville | Tennessee | - | - |
| Research Site | Seattle | Washington | - | - |
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