D9319C00001- 1L OC mono global RCT - MONO-OLA1

Study identifier:D9319C00001

ClinicalTrials.gov identifier:NCT04884360

EudraCT identifier:2020-005960-68

CTIS identifier:N/A

Recruitment Complete

Official Title

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)

Medical condition

ovarian cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Olaparib

Sex

Female

Actual Enrollment

367

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 31 May 2021
Estimated Primary Completion Date: 30 Apr 2025
Estimated Study Completion Date: 30 Apr 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria