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

  • STATUS
    Recruiting
  • participants needed
    228
  • sponsor
    AstraZeneca
Updated on 15 June 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (8.8 mi away) Contact
+171 other location
serum pregnancy test
measurable disease
oxaliplatin
carboplatin
bevacizumab
ovarian cancer
fallopian tube
cancer antigen 125
formalin-fixed paraffin-embedded
olaparib tablets

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).

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).

Details
Condition Ovarian Epithelial Cancer, Epithelial Ovarian Cancer, Epithelial Ovarian Carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary
Treatment Placebo, Active Comparator: Olaparib tablets
Clinical Study IdentifierNCT03106987
SponsorAstraZeneca
Last Modified on15 June 2021

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