CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 450 enrolled
Drug / intervention
Olaparib 300mg tabletsdrug
Likely dose
Olaparib 300mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01844986
NCT01844986Phase 3Active
CompareCT.gov

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

AstraZeneca·interventional·Posted May 3, 2013·Updated Dec 10, 2025

In Brief

A Phase 3 clinical trial evaluating Olaparib 300mg tablets for Newly Diagnosed and 6 related conditions. Active but no longer recruiting, targeting 450 participants across 177 sites in 15 countries.

Detailed Summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNewly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation, Complete Response, Partial Response, First Line Platinum Chemotherapy
CountriesAustralia, Brazil, Canada, China, France, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States
CollaboratorsGOG Foundation, Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

Timeline

Phase 3Active
20132014201520162017201820192020202120222023202420252026202720282029
First PostedMay 3, 2013
Enrollment StartAug 26, 2013
Primary CompletionMay 17, 2018
Study CompletionAug 29, 2028
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.2 years ago

Interventions

Olaparib 300mg tabletsdrug

Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.