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ACTIVE NOT RECRUITING
NCT01844986
PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

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.

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