CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 220 enrolled
Drug / intervention
Active Comparator: Olaparib tablets +1 moredrug
Likely dose
Active Comparator: Olaparib tablets 300mgfrom 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/NCT03106987
NCT03106987Phase 3Completed
CompareCT.gov

A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

AstraZeneca·interventional·Posted Apr 11, 2017·Updated Oct 7, 2022

In Brief

A Phase 3 clinical trial evaluating Active Comparator: Olaparib tablets and Placebo for Epithelial Ovarian Cancer. Completed, enrolled 220 participants across 82 sites in 11 countries.

Detailed Summary

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer
CountriesBelgium, Canada, Denmark, France, Germany, Israel, Italy, Norway, Poland, Spain, United Kingdom
CollaboratorsEuropean Network of Gynaecological Oncological Trial Groups (ENGOT)

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartJun 8, 2017
Primary CompletionFeb 15, 2021
Study CompletionFeb 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.2 years ago

Interventions

Active Comparator: Olaparib tabletsdrug

Olaparib 300mg Olaparib tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.

Placebodrug

Placebo 300mg placebo tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.