Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

August 26, 2013

Primary Completion Date

May 17, 2018

Study Completion Date

August 29, 2028

Conditions
Newly DiagnosedAdvanced Ovarian CancerFIGO Stage III-IVBRCA MutationComplete ResponsePartial ResponseFirst Line Platinum Chemotherapy
Interventions
DRUG

Olaparib 300mg tablets

Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Trial Locations (177)

43210

Research Site, Columbus

510060

Research Site, Guangzhou

Unknown

Clearview Cancer Institute, Huntsville

Providence Cancer Center, Anchorage

St. Joseph's Hospital & Medical Center, Phoenix

Cedars-Sinai Medical Center, Los Angeles

University of California, Los Angeles, Los Angeles

Kaiser Permanente, Oakland

Kaiser Permanente, Roseville

Stanford Women's Cancer Center, Stanford

Babak Edraki, Walnut Creek

University of Colorado, Aurora

Univ of Connecticut Health Center, Farmington

Smilow Cancer Hospital at Yale New Haven, New Haven

Florida Hospital Cancer Institute, Orlando

Gynecologic Cancer Center, Orlando

H Lee Moffitt Cancer Center and Research Institute, Tampa

Northside Hospital, Atlanta

Northeast Georgia Medical Center, Gainesville

Nancy N. & J.C. Lewis Cancer and Research Pavillion, Savannah

The Queen's Medical Center, Honolulu

University of Hawaii, Honolulu

Northwestern University, Chicago

Univ Chicago Medical Center, Chicago

Advocate Lutheran General Hospital, Park Ridge

Indiana University, Indianapolis

St. Vincent Hospital & Health Care Center, Indianapolis

Northern Indiana Cancer Research Consortium, Mishawaka

McFarland Clinic, P.C., Ames

Norton Cancer Institute Research, Louisville

Maine Medical Partners, Scarborough

Greater Baltimore Medical Center, Baltimore

Johns Hopkins, Baltimore

Walter Reed National Military Medical Center, Bethesda

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

Massachusetts General Hospital, Boston

Henry Ford Health System, Detroit

Gynecologic Oncology of West MI, PLLC, Grand Rapids

Minnesota Oncology Hematology, PA, Edina

Mayo Clinic - Rochester, MN, Rochester

University of Mississippi Medical Center, Jackson

Washington University School of Medicine, St Louis

Missouri Valley Cancer Consortium CCOP, Omaha

Nebraska Methodist Hospital, Omaha

Womens Cancer Center of Nevada, Las Vegas

MD Anderson at Cooper Cancer Center, Camden

John Theurer Cancer Center, Hackensack

University of New Mexico, Albuquerque

Women's Cancer Care Associates, Albany

Roswell Park Cancer Institute, Buffalo

Memorial Sloan Kettering Cancer Center, New York

Mount Sinai Medical Center - New York, New York

Perlmutter Cancer Center, New York

Hope Women's Cancer Centers, Asheville

UNC Chapel Hill, Chapel Hill

Levine Cancer Institute, Charlotte

Duke University Medical Center, Durham

Sanford Roger Maris Cancer Center, Fargo

Aultman Hospital, Canton

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland

Cleveland Clinic Foundation, Cleveland

University Hospital Case Medical Center, Cleveland

Kettering Medical Center, Kettering

Hillcrest Hospital Cancer Center, Mayfield Heights

Peggy and Charles Stephenson Cancer Center, Oklahoma City

Abington Memorial Hospital, Abington

St. Luke's University Health Network, Bethlehem

The University of Pennsylvania, Philadelphia

Women and Infants Hospital, Providence

South Carolina Oncology Associates, PA, Columbia

Avera Cancer Institute, Sioux Falls

Sanford Clinic Women's Health, Sioux Falls

University of Texas Southwestern Medical Center, Dallas

MD Anderson Cancer Center, Houston

University of Texas Health Science Center of Houston, Houston

University of Virginia, Charlottesville

Virginia Oncology Associates, Norfolk

Carilion Clinic Gynecological Oncology, Roanoke

Aurora Baycare Medical Center, Green Bay

University of Wisconsin-Madison, Madison

Froedtert Memorial Hospital, Milwaukee

Mercy Hospital for Women, Heidelberg

The Royal Womens Hospital, Parkville

Prince of Wales Hospital, Randwick

Centro Diagnóstico Barretos, Barretos

Hospital Araujo Jorge, Goiânia

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

Royal Victoria Hospital, Montreal

Hotel-Dieu de Quebec, Québec

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

Obstetris and Gynecology Hospital of Fudan University, Shanghai

Shanghai Cancer Hospital of Fudan University, Shanghai

The First Affiliated Hospital of Soochow Universit, 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

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

Institut Gustave Roussy, Villejuif

Rambam Health Care Campus, Haifa

Sapir Medical Centre, Kfar Saba

Rabin MC, Petah Tikva

Tel-Aviv Sourkasy Medical Center, Tel Aviv

Chaim Sheba Medical Centre, Tel Litwinsky

Bari- Istituto Tumori Giovanni Paolo II, Bari

"Azienda Ospedaliera Cannizzaro", Catania

Istituto Europeo di Oncologia, Milan

Istituto Nazionale Per Cura Tumori - Milano, Milan

Istituto Nazionale Tumori Fondazione Pascale, Napoli

Istituto Oncologico Veneto Irccs, Padua

Istituto Regina Elena-Polo Oncologico Ifo, Roma

Policlinico Universitario A. Gemelli, Roma

Hyogo CC, Akashi-shi

National Cancer Center Hosp, Chūōku

NHO Kyushu CC, Fukuoka

Saitama Med. Univ. Int. Med. C, Hidaka-shi

NHO Shikoku Cancer Center, Matsuyama

Niigata Univ. Med. Dent., Niigata

Hokkaido University Hospital, Sapporo

Shizuoka Cancer Center, Sunto-gun

Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam

Maastricht Universitair Medisch Centrum, Maastricht

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

Udmurtia Republic Clinical Oncology Center, Izhevsk

Chemotherapy Department, Russian Cancer Research Centre, Moscow

State Institution of Heath Omsk Regional Oncology Dispensary, Omsk

Cancer Research Institute, Saint Petersburg

Leningrad Regional Oncology Dispensary, Saint Petersburg

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

Research Institute of Oncology RAMS, Tomsk

National Cancer Center, Goyang-si

Asan Medical Center, Seoul

Gangnam Severance Hospital, Seoul

Korea Cancer Center Hospital, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Barcelona,H.Vall d´Hebrón,Oncología, Barcelona

Córdoba,H.Reina Sofía,Oncología, Córdoba

H.Llobregat,ICO-Duran i Reynals,Oncología, Hospitalet deLlobregat(Barcelo

Madrid, MD Anderson, Oncología, Madrid

Madrid,H.U.La Paz,Oncología, Madrid

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

Royal Marsden Hospital and Institute of Cancer Research, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

GOG Foundation

NETWORK

collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY