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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: olaparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00912743

D9010C00008

AGICC 09CRC01

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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.