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

Last updated: April 17, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Recurrent Ovarian Cancer

Allergy (Pediatric)

Allergy

Treatment

Placebo to match olaparib 300mg

Olaparib 300mg tablets

Clinical Study ID

NCT01874353
D0816C00002
2013-001211-75
  • Ages 18-130
  • Female

Study Summary

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.

  • Female patients with histologically diagnosed relapsed high grade serousovarian cancer (including primary peritoneal and / or fallopian tube cancer) orhigh grade endometrioid cancer.

  • Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious orsuspected deleterious (known or predicted to be detrimental/lead to loss offunction).

  • Patients who have received at least 2 previous lines of platinum containingtherapy prior to randomisation

For the penultimate chemotherapy course prior to enrolment on the study:

• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy

For the last chemotherapy course immediately prior to randomisation on the study:

  • Patients must be, in the opinion of the investigator, in response (partial orcomplete radiological response), or may have no evidence of disease (if optimalcytoreductive surgery was conducted prior to chemotherapy), and no evidence of arising CA-125, following completion of this chemotherapy course

  • Patient must have received a platinum based chemotherapy regimen (e.g. carboplatinor cisplatin) and have received at least 4 cycles of treatment

  • Patients must be randomized within 8 weeks of their last dose of chemotherapy

  • Maintenance treatment is allowed at the end of the penultimate platinum regimen,including bevacizumab

Exclusion

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).

  • BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance"or "Variant, favor polymorphism" or "benign polymorphism" etc.)

  • Patients who have had drainage of their ascites during the final 2 cycles of theirlast chemotherapy regimen prior to enrolment on the study.

Study Design

Total Participants: 327
Treatment Group(s): 2
Primary Treatment: Placebo to match olaparib 300mg
Phase: 3
Study Start date:
September 03, 2013
Estimated Completion Date:
December 31, 2025

Study Description

Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.

Connect with a study center

  • Mercy Hospital for Women

    Heidelberg,
    Australia

    Site Not Available

  • The Royal Womens Hospital

    Parkville,
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick,
    Australia

    Site Not Available

  • Research Site

    Brussels (Woluw?-St-Lambert),
    Belgium

    Site Not Available

  • Research Site

    Brussels (Woluwé-St-Lambert),
    Belgium

    Site Not Available

  • UCL Saint-Luc

    Brussels (Wuluw-St-Lambert),
    Belgium

    Site Not Available

  • U.Z. Gent

    Gent,
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven,
    Belgium

    Site Not Available

  • Hospital Araujo Jorge

    Goiania, GO
    Brazil

    Site Not Available

  • Hospital de Caridade de Ijuí

    Ijui, RS
    Brazil

    Site Not Available

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Centro de Referencia da Saude da Mulher

    Sao Paulo, SP
    Brazil

    Site Not Available

  • Fundacao da Faculdade Regional de Sao Jose do Rio Preto

    Sao Jose Do Rio Preto, Sao Paulo
    Brazil

    Site Not Available

  • Centro Diagnóstico Barretos

    Barretos,
    Brazil

    Site Not Available

  • Centro Regional Integrado de Oncologia

    Fortaleza,
    Brazil

    Site Not Available

  • Hospital Araujo Jorge

    Goiânia,
    Brazil

    Site Not Available

  • Hospital de Caridade de Ijuí

    Ijuí,
    Brazil

    Site Not Available

  • Centro de Novos Tratamentos Itajai

    Itajai,
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alagre

    Porto Alegre,
    Brazil

    Site Not Available

  • Instituto Nacional do Cancer

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Hospital de Base São José do Rio Preto

    São José do Rio Preto,
    Brazil

    Site Not Available

  • Centro de Referencia da Saude da Mulher

    São Paulo,
    Brazil

    Site Not Available

  • Instituto do Câncer de São Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Juravinski Cancer Centre

    Hamilton, Ontario
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Center

    Toronto, Ontario
    Canada

    Site Not Available

  • CHUM - Hopital Norte-Dame

    Montreal, Quebec
    Canada

    Site Not Available

  • CHUS Site Fleurimont

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • Hotel-Dieu de Quebec

    Quebec,
    Canada

    Site Not Available

  • Beijing Cancer Hospital

    Beijing,
    China

    Site Not Available

  • The Tumor Hospital affiliated to China Medical Science Insti

    Beijing,
    China

    Site Not Available

  • 1st Hospital of Jilin university

    Changchun,
    China

    Site Not Available

  • Jilin Provincial Cancer Hospital

    Changchun,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha,
    China

    Site Not Available

  • West China Hospital Affiliated to Sichuan University

    Chengdu,
    China

    Site Not Available

  • ChongQing Cancer Hospital

    Chongqing,
    China

    Site Not Available

  • Fujian general hospital of Nanjing Military Command

    Fuzhou,
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Women's Hospital, Zhejaing University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • The Tumour Hospital of Harbin Medical University

    Harbin,
    China

    Site Not Available

  • Zhejiang Cancer Hospital, Huangzhou

    Huangzhou,
    China

    Site Not Available

  • JINAN, Qi Lu Hosp. of SD Univ.

    Ji Nan,
    China

    Site Not Available

  • JiangSu Cancer Hospital

    Nanjing,
    China

    Site Not Available

  • Affiliated tumor hospital to Guangxi medical university

    Nanning,
    China

    Site Not Available

  • Research Site

    Shanghai, 200011
    China

    Site Not Available

  • Shanghai Cancer Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou,
    China

    Site Not Available

  • First affiliated hospital college of XianJiaotong University

    Xian,
    China

    Site Not Available

  • Institut Bergonie

    Bordeaux,
    France

    Site Not Available

  • CAC François Baclesse

    Caen Cedex,
    France

    Site Not Available

  • 69LYON, C Bérard, Onco

    Lyon Cedex 08,
    France

    Site Not Available

  • Centre Catherine de Sienne

    Nantes,
    France

    Site Not Available

  • Centre Catherine de Sienne

    Nantes,,
    France

    Site Not Available

  • 75PARIS, H Tenon, Onco

    Paris,
    France

    Site Not Available

  • Hopital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • Institut Curie Paris Et Saint Cloud

    Paris Cedex 5,
    France

    Site Not Available

  • 69PIERREBE, CH Lyon Sud,

    Pierre Benite Cedex,
    France

    Site Not Available

  • 92STCLOUD, C Huguenin, Onco

    Saint Cloud,
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse,
    France

    Site Not Available

  • Centre Alexis Vautrin

    Vandoeuvre Les Nancy,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex,
    France

    Site Not Available

  • Helios-Kliniken Berlin - Buch

    Berlin,
    Germany

    Site Not Available

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    Erlangen,
    Germany

    Site Not Available

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

    Essen,
    Germany

    Site Not Available

  • Johann-Wolfgang Goethe-Universität

    Frankfurt,
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Klinikum der Universität zu Köln

    Koln,
    Germany

    Site Not Available

  • Klinikum der Universität zu Köln

    Köln,
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lubeck,
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck,
    Germany

    Site Not Available

  • Research Site

    Marburg,
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität

    Munchen,
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität

    München,
    Germany

    Site Not Available

  • Onkologie Ravensburg

    Ravensburg,
    Germany

    Site Not Available

  • Universitätsklinikum Rostock

    Rostock,
    Germany

    Site Not Available

  • Rambam Health Care Campus

    Haifa,
    Israel

    Site Not Available

  • Sapir Medical Centre

    Kfar Saba,
    Israel

    Site Not Available

  • Tel Hashomer

    Ramat Gan,
    Israel

    Site Not Available

  • Research Site

    Tel Hashomer,
    Israel

    Site Not Available

  • Research Site

    Genova, GE
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano,
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico Di Modena

    Modena,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione Pascale

    Napoli,
    Italy

    Site Not Available

  • Istituto Oncologico Veneto Irccs

    Padova,
    Italy

    Site Not Available

  • Istituto Regina Elena-Polo Oncologico Ifo

    Roma,
    Italy

    Site Not Available

  • Policlinico Universitario A. Gemelli

    Roma,
    Italy

    Site Not Available

  • Hyogo Cancer Center

    Akashi-shi,
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku,
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka,
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka-shi,
    Japan

    Site Not Available

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama-shi,
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigata-shi,
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama-shi,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo-shi,
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Sunto-gun,
    Japan

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

    Amsterdam,
    Netherlands

    Site Not Available

  • Maastricht Universitair Medisch Centrum

    Maastricht,
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum St. Radboud

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam,
    Netherlands

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

    Grzepnica,
    Poland

    Site Not Available

  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn,
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn,
    Poland

    Site Not Available

  • Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

    Warszawa,
    Poland

    Site Not Available

  • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

    Warszawa,
    Poland

    Site Not Available

  • Chemotherapy Department, Russian Cancer Research Centre

    Moscow,
    Russian Federation

    Site Not Available

  • St.Petersburg City Oncology Dispensary, Dept. Gynecology

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Leningrad Regional Oncology Dispensary

    St.Petersburg,
    Russian Federation

    Site Not Available

  • Córdoba,H.Reina Sofía,Oncología

    Cordoba, Andalucia
    Spain

    Site Not Available

  • Barcelona,H.Clinic i Provincial,Oncología

    Barcelona,
    Spain

    Site Not Available

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

    Barcelona,
    Spain

    Site Not Available

  • Córdoba,H.Reina Sofía,Oncología

    Córdoba,
    Spain

    Site Not Available

  • Gerona,H.Josep Trueta,Oncología

    Gerona,
    Spain

    Site Not Available

  • Madrid, H.C.S.Carlos,Oncología

    Madrid,
    Spain

    Site Not Available

  • Madrid,H.12 de Octubre,Oncología

    Madrid,
    Spain

    Site Not Available

  • Oviedo,H.Cent.Asturias,Onco

    Oviedo,
    Spain

    Site Not Available

  • Hospital Provincial de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Valencia, IVO, Oncología

    Valencia,
    Spain

    Site Not Available

  • Valencia,H.C.U.Valencia,Oncología

    Valencia,
    Spain

    Site Not Available

  • City Hospital Birmingham Cancer Trials Team

    Birmingham,
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge,
    United Kingdom

    Site Not Available

  • Arden Cancer Centre

    Coventry,
    United Kingdom

    Site Not Available

  • Edinburgh Cancer Research UK Centre

    Edinburgh,
    United Kingdom

    Site Not Available

  • Cancer Research UK and UCL Cancer Trials Centre

    London,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London,
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital and Institute of Cancer Research

    Sutton,
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California
    United States

    Site Not Available

  • Palo Alto Foundation Medical Group

    San Francisco, California
    United States

    Site Not Available

  • Palo Alto Foundation Medical Group

    San Fransisco, California
    United States

    Site Not Available

  • Research Site

    Stanford, California
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado
    United States

    Site Not Available

  • The Hospital of Central Connecticut

    New Britain, Connecticut
    United States

    Site Not Available

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut
    United States

    Site Not Available

  • Salom and Tangir LLC

    Miramar, Florida
    United States

    Site Not Available

  • Gynecologic Cancer Center

    Orlando, Florida
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois
    United States

    Site Not Available

  • North Shore University

    Evanston, Illinois
    United States

    Site Not Available

  • Greater Baltimore Medical Center

    Baltimore, Maryland
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts
    United States

    Site Not Available

  • MD Anderson at Cooper Cancer Center

    Camden, New Jersey
    United States

    Site Not Available

  • MD Anderson at Cooper Cancer Center

    Voorhees, New Jersey
    United States

    Site Not Available

  • Womens Cancer Care Associates

    Albany, New York
    United States

    Site Not Available

  • Winthrop Gynecologic Oncology Associates

    Mineola, New York
    United States

    Site Not Available

  • Perlmutter Cancer Center

    New York, New York
    United States

    Site Not Available

  • OSU JamesCare at Mill Run

    Hillard, Ohio
    United States

    Site Not Available

  • OSU JamesCare at Mill Run

    Hilliard, Ohio
    United States

    Site Not Available

  • Research Site

    Abington, Pennsylvania
    United States

    Site Not Available

  • Henry Joyce Cancer Clinic

    Nashville, Tennessee
    United States

    Site Not Available

  • University of Texas

    Houston, Texas
    United States

    Site Not Available

  • Aurora St Lukes Medical Center

    Milwaukee, Wisconsin
    United States

    Site Not Available

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