327
Participants
Start Date
September 3, 2013
Primary Completion Date
September 19, 2016
Study Completion Date
December 31, 2025
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.
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.
Research Site, Shanghai
Research Site, Guangzhou
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
Lead Sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Myriad Genetic Laboratories, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
AstraZeneca
INDUSTRY