Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2016

Primary Completion Date

June 30, 2019

Study Completion Date

June 30, 2019

Conditions
Platinum Sensitive Relapsed Ovarian Cancer
Interventions
DRUG

OLAPARIB

Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

DRUG

PLACEBO

Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Trial Locations (29)

Unknown

Research Site, Mobile

Research Site, Phoenix

Research Site, Los Angeles

Research Site, Stanford

Research Site, Augusta

Research Site, Park Ridge

Research Site, Iowa City

Research Site, Louisville

Research Site, Covington

Research Site, Scarborough

Research Site, Baltimore

Research Site, Albany

Research Site, Oklahoma City

Research Site, Philadelphia

Research Site, Milwaukee

Research Site, Chiclayo

Research Site, Lima

Research Site, Quezon City

Research Site, Goyang-si

Research Site, Seongnam-si

Research Site, Seoul

Research Site, Birmingham

Research Site, Cambridge

Research Site, Coventry

Research Site, Edinburgh

Research Site, London

Research Site, Manchester

Research Site, Oxford

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

lead

AstraZeneca

INDUSTRY