At a glance
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A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants With BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)
In Brief
A Phase 3 clinical trial evaluating Olaparib and Matching placebo for Ovarian Cancer. Active but no longer recruiting, targeting 366 participants across 89 sites in 10 countries.
Detailed Summary
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.
Study Details
Timeline
Interventions
Olaparib tablets 300 mg oral twice daily
Matching placebo tablets taken orally at a dose of 300 mg twice daily