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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: September 22, 2016
Last verified: September 2016

May 28, 2009
September 22, 2016
May 2009
March 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
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)
Tumor response as assessed by RECIST [ Time Frame: 6 weekly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00912743 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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
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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.
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Interventional
Phase 2
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
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*   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 to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00912743
D9010C00008, AGICC 09CRC01
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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
September 2016

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