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

NCT03106987 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-10-07

Study results available
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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)

Conditions

  • Epithelial Ovarian Cancer

Interventions

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.

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Eric Pujade-Lauraine, MD, PhD · Hôpital Hôtel-Dieu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2021-02-15
Completion
2022-02-17

Countries

  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Norway
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106987 on ClinicalTrials.gov