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

Sponsor
AstraZeneca
Study ID
NCT03106987
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: Olaparib tablets — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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)

Key Dates

Start date
Jun 8, 2017
Status verified
Jun 2022
Primary completion
Feb 15, 2021
Completion
Feb 17, 2022

Study Design

Enrollment
220 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Comparator: Olaparib
    Olaparib 300mg tablets administered orally twice daily continuously.
  • Placebo Comparator: Placebo Comparator: Placebo
    Matching placebo 300mg tablets administered orally twice daily continuously.

Primary Outcome Measure

Efficacy: Progression-free Survival (PFS) [ Time Frame: At randomization visit and at every 12 weeks (+/- 7 days) until objective radiological disease progression as determined by the investigator or other discontinuation criteria are met (assessed upto 3.8 years) ]

Related Studies