Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
- Sponsor
- AstraZeneca
- Study ID
- NCT03402841
- Phase
- PHASE3
- Status
- Completed
Conditions
- Non-Germline BRCA Mutated Ovarian Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 95 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUG300 mg twice daily - oral
Study Details
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Key Dates
- Start date
- Jan 30, 2018
- Status verified
- Jul 2024
- Primary completion
- Oct 2, 2020
- Completion
- Mar 10, 2022
Study Design
- Enrollment
- 279 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OlaparibOlaparib will be supplied as film-coated tablets containing 150 mg or 100 mg of olaparib. Patients will be administered olaparib orally twice daily (bid) at 300 mg.
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: Up to maximum of 32 months ]