drugset / Trial / NCT02476968

To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer

NCT02476968

Phase 4 Completed 181 enrolled AstraZeneca
Non-randomizedSingle-groupOpen-labelOther

Summary

This is a prospective, open-label, single arm, multi-center study to assess the real world clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule formulation (in line with the EU approved prescribing information) and will be conducted in platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) who carry germline or somatic BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious \[known or predicted to be detrimental/lead to loss of function\]).

Timeline

Start
2015-09-28
Primary completion
2020-04-17
Completion
2021-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 400 mg Oral