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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912743
• Other study ID #: D9010C00008
• Secondary ID: AGICC 09CRC01
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2009
• Last updated: May 20, 2013
• Start date: May 2009
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Microsatellite Instability

Intervention

Drug:
• olaparib
400 mg po bid continuously

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Los Angeles	California
United States	Research Site	Miami Beach	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Palm Springs	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by RECIST		6 weekly	No

External Links

•   Cancer Study Locator (US and Canada only)