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
Overview
- Phase
- Phase 2
- Intervention
- olaparib
- Conditions
- Colorectal Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Tumour Response
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
1
MSI - H arm
Intervention: olaparib
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- 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)