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Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00912743
First received: May 28, 2009
Last updated: May 20, 2013
Last verified: May 2013

May 28, 2009
May 20, 2013
May 2009
March 2012   (final data collection date for primary outcome measure)
Tumor response as assessed by RECIST [ Time Frame: 6 weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00912743 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: olaparib
400 mg po bid continuously
Experimental: 1
MSI - H arm
Intervention: Drug: olaparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00912743
D9010C00008, AGICC 09CRC01
Not Provided
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP