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Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Sponsor: AstraZeneca
Summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Official title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Key Details
Gender
FEMALE
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2013-08-26
Completion Date
2028-08-29
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (177)
Clearview Cancer Institute
Huntsville, Alabama, United States
Providence Cancer Center
Anchorage, Alaska, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Kaiser Permanente
Oakland, California, United States
Kaiser Permanente
Roseville, California, United States
Stanford Women's Cancer Center
Stanford, California, United States
Babak Edraki
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
Univ of Connecticut Health Center
Farmington, Connecticut, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Gynecologic Cancer Center
Orlando, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Univ Chicago Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
Mishawaka, Indiana, United States
McFarland Clinic, P.C.
Ames, Iowa, United States
Norton Cancer Institute Research
Louisville, Kentucky, United States
Maine Medical Partners
Scarborough, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Gynecologic Oncology of West MI, PLLC
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, PA
Edina, Minnesota, United States
Mayo Clinic - Rochester, MN
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Womens Cancer Center of Nevada
Las Vegas, Nevada, United States
MD Anderson at Cooper Cancer Center
Camden, New Jersey, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Women's Cancer Care Associates
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center - New York
New York, New York, United States
Perlmutter Cancer Center
New York, New York, United States
Hope Women's Cancer Centers
Asheville, North Carolina, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Aultman Hospital
Canton, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford Clinic Women's Health
Sioux Falls, South Dakota, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center of Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States
Aurora Baycare Medical Center
Green Bay, Wisconsin, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States
Mercy Hospital for Women
Heidelberg, Australia
The Royal Womens Hospital
Parkville, Australia
Prince of Wales Hospital
Randwick, Australia
Centro Diagnóstico Barretos
Barretos, Brazil
Hospital Araujo Jorge
Goiânia, Brazil
Centro de Novos Tratamentos Itajai
Itajaí, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre
Porto Alegre, Brazil
Hospital de Base São José do Rio Preto
São José do Rio Preto, Brazil
Centro de Referencia da Saude da Mulher
São Paulo, Brazil
Instituto do Câncer de São Paulo
São Paulo, Brazil
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
CHUM - Hopital Norte-Dame
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hotel-Dieu de Quebec
Québec, Quebec, Canada
Beijing Cancer Hospital
Beijing, China
The Tumor Hospital affiliated to China Medical Science Insti
Beijing, China
1st Hospital of Jilin university
Changchun, China
Jilin Provincial Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
West China Hospital Affiliated to Sichuan University
Chengdu, China
ChongQing Cancer Hospital
Chongqing, China
Research Site
Guangzhou, China
Women's Hospital, Zhejaing University School of Medicine
Hangzhou, China
The Tumour Hospital of Harbin Medical University
Harbin, China
Zhejiang Cancer Hospital, Huangzhou
Huangzhou, China
JINAN, Qi Lu Hosp. of SD Univ.
Jinan, China
Obstetris and Gynecology Hospital of Fudan University
Shanghai, China
Shanghai Cancer Hospital of Fudan University
Shanghai, China
The First Affiliated Hospital of Soochow Universit
Suzhou, China
First affiliated hospital college of XianJiaotong University
Xi'an, China
Institut Bergonie
Bordeaux, France
CAC François Baclesse
Caen, France
69LYON, C Bérard, Onco
Lyon, France
Centre Catherine de Sienne
Nantes, France
75PARIS, H Tenon, Onco
Paris, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Rambam Health Care Campus
Haifa, Israel
Sapir Medical Centre
Kfar Saba, Israel
Rabin MC
Petah Tikva, Israel
Tel-Aviv Sourkasy Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Centre
Tel Litwinsky, Israel
Bari- Istituto Tumori Giovanni Paolo II
Bari, Italy
Azienda Ospedaliera "Cannizzaro"
Catania, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Per Cura Tumori - Milano
Milan, Italy
Istituto Nazionale Tumori Fondazione Pascale
Naples, Italy
Istituto Oncologico Veneto Irccs
Padova, Italy
Istituto Regina Elena-Polo Oncologico Ifo
Roma, Italy
Policlinico Universitario A. Gemelli
Roma, Italy
Hyogo CC
Akashi-shi, Japan
National Cancer Center Hosp
Chūōku, Japan
NHO Kyushu CC
Fukuoka, Japan
Saitama Med. Univ. Int. Med. C
Hidaka-shi, Japan
NHO Shikoku Cancer Center
Matsuyama, Japan
Niigata Univ. Med. Dent.
Niigata, Japan
Hokkaido University Hospital
Sapporo, Japan
Shizuoka Cancer Center
Sunto-gun, Japan
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
Grzepnica, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
Warsaw, Poland
Udmurtia Republic Clinical Oncology Center
Izhevsk, Russia
Chemotherapy Department, Russian Cancer Research Centre
Moscow, Russia
State Institution of Heath Omsk Regional Oncology Dispensary
Omsk, Russia
Cancer Research Institute
Saint Petersburg, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, Russia
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg, Russia
Research Institute of Oncology RAMS
Tomsk, Russia
National Cancer Center
Goyang-si, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Barcelona,H.Vall d´Hebrón,Oncología
Barcelona, Spain
Córdoba,H.Reina Sofía,Oncología
Córdoba, Spain
H.Llobregat,ICO-Duran i Reynals,Oncología
Hospitalet deLlobregat(Barcelo, Spain
Madrid, MD Anderson, Oncología
Madrid, Spain
Madrid,H.U.La Paz,Oncología
Madrid, Spain
Valencia, IVO, Oncología
Valencia, Spain
Valencia,H.C.U.Valencia,Oncología
Valencia, Spain
City Hospital, Birmingham, Cancer Trials Team
Birmingham, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Arden Cancer Centre
Coventry, United Kingdom
Edinburgh Cancer Research UK Centre
Edinburgh, United Kingdom
Cancer Research UK and UCL Cancer Trials Centre
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Royal Marsden Hospital and Institute of Cancer Research
Sutton, United Kingdom