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

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ClinicalTrials.gov Identifier: NCT00912743
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: olaparib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: 1
MSI - H arm
Drug: olaparib
400 mg po bid continuously




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
    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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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, New York
Research Site
New York, New York, 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912743     History of Changes
Other Study ID Numbers: D9010C00008
AGICC 09CRC01
First Posted: June 3, 2009    Key Record Dates
Results First Posted: November 9, 2016
Last Update Posted: November 9, 2016
Last Verified: September 2016

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
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents