NCT01874353

Trial name or title	Olaparib treatment in BRCA mutated ovarian cancer patients after complete or partial response to platinum chemotherapy
Methods	A phase III, randomised, double‐blind, placebo‐controlled, multicentre study to assess the efficacy of olaparib maintenance monotherapy
Participants	Women with relapsed high‐grade serous ovarian cancer (HGSOC) (including patients with primary peritoneal and/or fallopian tube cancer) or high‐grade endometrioid cancer with 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)) who have responded following platinum‐based chemotherapy
Interventions	300 mg olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator. Dose reduction to 250 mg and subsequently 200 mg is permitted following confirmation of toxicity
Outcomes	Progression‐free survival (PFS) by central review of RECIST data Overall survival Quality of life analysis Safety and tolerability
Starting date	September 2013
Contact information	Elizabeth Lowe, AstraZeneca: ClinicalTrialTransparency@astrazeneca.com
Notes	Estimated completion date June 2020; estimated enrolment = 440; Last updated 2 Feb 2015. Last accessed 7 April 2015.