Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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: 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:
  • 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)


Secondary Outcome Measures:
  • 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


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 to 130 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912743     History of Changes
Other Study ID Numbers: D9010C00008  AGICC 09CRC01 
Study First Received: May 28, 2009
Results First Received: January 13, 2015
Last Updated: September 22, 2016
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
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016