Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non gBRCAm Ovarian Cancer Patients - OPINION

Study identifier:D0816C00020

ClinicalTrials.gov identifier:NCT03402841

EudraCT identifier:2017-002767-17

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non-Germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy

Medical condition

non-Germline BRCA Mutated Ovarian Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Olaparib

Sex

Female

Actual Enrollment

279

Study type

Interventional

Age

18 Years - 95 Years

Date

Study Start Date: 30 Jan 2018
Primary Completion Date: 02 Oct 2020
Study Completion Date: 10 Mar 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA, Myriad Genetics, Covance, Theradex, Parexel International

Inclusion and exclusion criteria