NCT03106987

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The OReO study will investigate the efficacy and safety of Olaparib maintenance re-treatment in patients with relapsed non-mucinous EOC, who have had disease progression following maintenance therapy with a Polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125. Patients will be enrolled on the basis of their breast cancer susceptibility gene (BRCA1, BRCA2) status into one of two cohorts (BRCA1/2 \[+ve\] and BRCA1/2 \[-ve\]). The BRCA1/2 (+ve) and BRCA1/2 (-ve) cohorts will be randomised separately. Within each cohort, patients will be randomised by prospective allocation in a 2:1 ratio (Olaparib: matching placebo).

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Active Comparator: Olaparib tablets	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.
DRUG	Placebo	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.

Timeline

• Start date: 2017-06-08
• Primary completion: 2021-02-15
• Completion: 2022-02-17
• First posted: 2017-04-11
• Last updated: 2022-10-07
• Results posted: 2022-04-19

Locations

82 sites across 11 countries: Belgium, Canada, Denmark, France, Germany, Israel, Italy, Norway, Poland, Spain, United Kingdom