Back to resultsEfficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
olaparib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Olaparib, MSI status, Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
MSI - H arm
Outcomes
Primary Outcome Measures
Tumour Response
Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)
Secondary Outcome Measures
Progression Free Survival
Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
Overall Survival
Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00912743
Brief Title
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Olaparib, MSI status, Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MSI - H arm
Intervention Type
Drug
Intervention Name(s)
olaparib
Intervention Description
400 mg po bid continuously
Primary Outcome Measure Information:
Title
Tumour Response
Description
Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)
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
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
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
Title
Overall Survival
Description
Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive
Time Frame
Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence P Leichman, MD
Organizational Affiliation
Aptium Oncology Gastrointestinal Cancer Consortium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bert H O'Neil, MD
Organizational Affiliation
Aptium Oncology Gastrointestinal Cancer Consortium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Robertson, BSc, MBCHB, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=638&filename=D9010C00008.pdf
Description
CSR_Synopsis_D9010C00008
Learn more about this trial
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
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