Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

September 3, 2013

Primary Completion Date

September 19, 2016

Study Completion Date

December 31, 2025

Conditions
Platinum SensitiveBRCA MutatedRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based Chemotherapy
Interventions
DRUG

Olaparib 300mg tablets

300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

DRUG

Placebo to match olaparib 300mg

300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Trial Locations (126)

200011

Research Site, Shanghai

510060

Research Site, Guangzhou

Unknown

University of Alabama at Birmingham, Birmingham

Palo Alto Foundation Medical Group, San Francisco

University of Colorado, Aurora

The Hospital of Central Connecticut, New Britain

Gynecologic Cancer Center, Orlando

North Shore University, Evanston

Greater Baltimore Medical Center, Baltimore

Johns Hopkins, Baltimore

Dana Farber Cancer Institute, Boston

Massachusetts General Hospital, Boston

MD Anderson at Cooper Cancer Center, Voorhees Township

Womens Cancer Care Associates, Albany

Winthrop Gynecologic Oncology Associates, Mineola

OSU JamesCare at Mill Run, Hilliard

Henry Joyce Cancer Clinic, Nashville

Aurora St Lukes Medical Center, Milwaukee

Mercy Hospital for Women, Heidelberg

The Royal Womens Hospital, Parkville

Prince of Wales Hospital, Randwick

U.Z. Gent, Ghent

UZ Leuven Gasthuisberg, Leuven

Centro Diagnóstico Barretos, Barretos

Centro Regional Integrado de Oncologia, Fortaleza

Hospital Araujo Jorge, Goiânia

Hospital de Caridade de Ijuí, Ijuí

Centro de Novos Tratamentos Itajai, Itajaí

Hospital de Clinicas de Porto Alegre, Porto Alegre

Irmandade da Santa Casa de Misericordia de Porto Alagre, Porto Alegre

Hospital de Base São José do Rio Preto, São José do Rio Preto

Centro de Referencia da Saude da Mulher, São Paulo

Instituto do Câncer de São Paulo, São Paulo

Juravinski Cancer Centre, Hamilton

London Health Sciences Centre, London

Princess Margaret Cancer Centre, Toronto

Sunnybrook Health Sciences Center, Toronto

CHUM - Hopital Norte-Dame, Montreal

Hotel-Dieu de Quebec, Québec

CHUS Site Fleurimont, Sherbrooke

Beijing Cancer Hospital, Beijing

The Tumor Hospital affiliated to China Medical Science Insti, Beijing

1st Hospital of Jilin university, Changchun

Jilin Provincial Cancer Hospital, Changchun

Hunan Cancer Hospital, Changsha

West China Hospital Affiliated to Sichuan University, Chengdu

ChongQing Cancer Hospital, Chongqing

Women's Hospital, Zhejaing University School of Medicine, Hangzhou

The Tumour Hospital of Harbin Medical University, Harbin

Zhejiang Cancer Hospital, Huangzhou, Huangzhou

JINAN, Qi Lu Hosp. of SD Univ., Jinan

Shanghai Cancer Hospital of Fudan University, Shanghai

The First Affiliated Hospital of Soochow University, Suzhou

First affiliated hospital college of XianJiaotong University, Xi'an

Institut Bergonie, Bordeaux

CAC François Baclesse, Caen

69LYON, C Bérard, Onco, Lyon

Centre Catherine de Sienne, Nantes

75PARIS, H Tenon, Onco, Paris

Hopital Européen Georges Pompidou, Paris

Institut Curie Paris Et Saint Cloud, Paris

69PIERREBE, CH Lyon Sud,, Pierre-Bénite

92STCLOUD, C Huguenin, Onco, Saint-Cloud

Institut Claudius Regaud, Toulouse

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

Institut Gustave Roussy, Villejuif

Helios-Kliniken Berlin - Buch, Berlin

Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen

Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH, Essen

Johann-Wolfgang Goethe-Universität, Frankfurt

Medizinische Hochschule Hannover, Hanover

Universitätsklinikum Schleswig-Holstein, Lübeck

Klinikum rechts der Isar der Technischen Universität, München

Onkologie Ravensburg, Ravensburg

Universitätsklinikum Rostock, Rostock

Rambam Health Care Campus, Haifa

Sapir Medical Centre, Kfar Saba

Tel Hashomer, Ramat Gan

Istituto Europeo di Oncologia, Milan

Azienda Ospedaliera Policlinico Di Modena, Modena

Istituto Nazionale Tumori Fondazione Pascale, Napoli

Istituto Oncologico Veneto Irccs, Padua

Istituto Regina Elena-Polo Oncologico Ifo, Roma

Policlinico Universitario A. Gemelli, Roma

Hyogo Cancer Center, Akashi-shi

National Cancer Center Hospital, Chūōku

National Hospital Organization Kyushu Cancer Center, Fukuoka

Saitama Medical University International Medical Center, Hidaka-shi

National Hospital Organization Shikoku Cancer Center, Matsuyama

Niigata University Medical and Dental Hospital, Niigata

Kindai University Hospital, Osakasayama-shi

Hokkaido University Hospital, Sapporo

Shizuoka Cancer Center, Sunto-gun

Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam

Maastricht Universitair Medisch Centrum, Maastricht

Universitair Medisch Centrum St. Radboud, Nijmegen

Erasmus Medisch Centrum, Rotterdam

Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna, Grzepnica

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii, Olsztyn

Wojewódzki Szpital Specjalistyczny w Olsztynie, Olsztyn

Centrum Onkologii Instytut im Marii Sklodowskiej-Curie, Warsaw

Szpital Specjalistyczny im. Swietej Rodziny SPZOZ, Warsaw

Chemotherapy Department, Russian Cancer Research Centre, Moscow

Leningrad Regional Oncology Dispensary, Saint Petersburg

St.Petersburg City Oncology Dispensary, Dept. Gynecology, Saint Petersburg

Asan Medical Center, Seoul

Gangnam Severance Hospital, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Barcelona,H.Clinic i Provincial,Oncología, Barcelona

Barcelona,H.de la Sta.Creu i S.Pau,Oncología, Barcelona

Córdoba,H.Reina Sofía,Oncología, Córdoba

Gerona,H.Josep Trueta,Oncología, Girona

Madrid, H.C.S.Carlos,Oncología, Madrid

Madrid,H.12 de Octubre,Oncología, Madrid

Hospital Provincial de Navarra, Pamplona

Valencia, IVO, Oncología, Valencia

Valencia,H.C.U.Valencia,Oncología, Valencia

City Hospital Birmingham Cancer Trials Team, Birmingham

Addenbrooke's Hospital, Cambridge

Arden Cancer Centre, Coventry

Edinburgh Cancer Research UK Centre, Edinburgh

Cancer Research UK and UCL Cancer Trials Centre, London

Royal Marsden Hospital, London

The Christie NHS Foundation Trust, Manchester

Royal Marsden Hospital and Institute of Cancer Research, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY