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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: olaparib

• Registration Number: NCT00912743
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2013-05-20
• Disposition First Submitted QC: 2013-05-20
• Disposition First Posted: 2013-05-27
• Results First Submitted: 2015-01-13
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Results First Posted: 2016-11-09
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	olaparib	MSI - H arm

Primary Outcome Measures

Name	Time	Method
Tumour Response	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

Name	Time	Method
Progression Free Survival	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.
Overall Survival	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States