Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00912743
First received: May 28, 2009
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: olaparib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Tumor response as assessed by RECIST [ Time Frame: 6 weekly ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | May 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MSI - H arm
|
Drug: olaparib
400 mg po bid continuously
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912743
Locations
| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| Research Site | |
| Palm Springs, California, United States | |
| United States, Colorado | |
| Research Site | |
| Aurora, Colorado, United States | |
| United States, Delaware | |
| Research Site | |
| Newark, Delaware, United States | |
| United States, Florida | |
| Research Site | |
| Miami Beach, Florida, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| Research Site | |
| Chapel Hill, North Carolina, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| Research Site | |
| Nashville, Tennessee, United States | |
| United States, Washington | |
| Research Site | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Lawrence P Leichman, MD | Aptium Oncology Gastrointestinal Cancer Consortium |
| Principal Investigator: | Bert H O'Neil, MD | Aptium Oncology Gastrointestinal Cancer Consortium |
| Study Director: | Jane Robertson, BSc, MBCHB, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00912743 History of Changes |
| Other Study ID Numbers: | D9010C00008, AGICC 09CRC01 |
| Study First Received: | May 28, 2009 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Colorectal cancer Olaparib MSI status |
Stage IV Measurable Colorectal Cancer Stratified by MSI Status |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Microsatellite Instability Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Genomic Instability Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013