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Can a daily pill keep BRCA-Linked ovarian cancer at bay?

NCT ID NCT01874353

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This Phase 3 trial is investigating whether the drug olaparib can help women with a specific type of ovarian cancer stay in remission longer. The study includes women whose cancer has returned but responded well to platinum-based chemotherapy, and who carry a BRCA gene mutation. Participants take olaparib or a placebo daily to see if the drug delays cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a drug called olaparib, taken as tablets
What this could lead to
If successful, this could offer a way to delay cancer progression in women with BRCA-mutated ovarian cancer, potentially extending the time before the disease worsens.
What could go wrong
This is a Phase 3 trial, but it is testing maintenance therapy, not a cure. Side effects from olaparib may occur, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

327 people

The number who actually took part.

Started

Sep 2013

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must be ≥ 18 years of age. * Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer. * 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). * Patients who have received at least 2 previous lines of platinum containing therapy 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 or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course * Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or 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 Criteria: * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff 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 their last chemotherapy regimen prior to enrolment on the study.

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Conditions

The condition(s) this trial relates to.

endometrial endometrioid adenocarcinoma fallopian tube cancer ovarian cancer ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRCA mutated Following complete or partial response to platinum based chemotherapy Platinum-sensitive Relapsed ovarian cancer

Contacts and locations

Locations

  • 1st Hospital of Jilin university

    Changchun, China

  • 69LYON, C Bérard, Onco

    Lyon, France

  • 69PIERREBE, CH Lyon Sud,

    Pierre-Bénite, France

  • 75PARIS, H Tenon, Onco

    Paris, France

  • 92STCLOUD, C Huguenin, Onco

    Saint-Cloud, France

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Arden Cancer Centre

    Coventry, United Kingdom

  • Asan Medical Center

    Seoul, South Korea

  • Aurora St Lukes Medical Center

    Milwaukee, Wisconsin, United States

  • Azienda Ospedaliera Policlinico Di Modena

    Modena, Italy

  • Barcelona,H.Clinic i Provincial,Oncología

    Barcelona, Spain

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

    Barcelona, Spain

  • Beijing Cancer Hospital

    Beijing, China

  • CAC François Baclesse

    Caen, France

  • CHUM - Hopital Norte-Dame

    Montreal, Quebec, Canada

  • CHUS Site Fleurimont

    Sherbrooke, Quebec, Canada

  • Cancer Research UK and UCL Cancer Trials Centre

    London, United Kingdom

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Centre Catherine de Sienne

    Nantes, France

  • Centro Diagnóstico Barretos

    Barretos, Brazil

  • Centro Regional Integrado de Oncologia

    Fortaleza, Brazil

  • Centro de Novos Tratamentos Itajai

    Itajaí, Brazil

  • Centro de Referencia da Saude da Mulher

    São Paulo, Brazil

  • Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

    Warsaw, Poland

  • Chemotherapy Department, Russian Cancer Research Centre

    Moscow, Russia

  • ChongQing Cancer Hospital

    Chongqing, China

  • City Hospital Birmingham Cancer Trials Team

    Birmingham, United Kingdom

  • Córdoba,H.Reina Sofía,Oncología

    Córdoba, Spain

  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

  • Edinburgh Cancer Research UK Centre

    Edinburgh, United Kingdom

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • First affiliated hospital college of XianJiaotong University

    Xi'an, China

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    Erlangen, Germany

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Gerona,H.Josep Trueta,Oncología

    Girona, Spain

  • Greater Baltimore Medical Center

    Baltimore, Maryland, United States

  • Gynecologic Cancer Center

    Orlando, Florida, United States

  • Helios-Kliniken Berlin - Buch

    Berlin, Germany

  • Henry Joyce Cancer Clinic

    Nashville, Tennessee, United States

  • Hokkaido University Hospital

    Sapporo, Japan

  • Hopital Européen Georges Pompidou

    Paris, France

  • Hospital Araujo Jorge

    Goiânia, Brazil

  • Hospital Provincial de Navarra

    Pamplona, Spain

  • Hospital de Base São José do Rio Preto

    São José do Rio Preto, Brazil

  • Hospital de Caridade de Ijuí

    Ijuí, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Brazil

  • Hotel-Dieu de Quebec

    Québec, Quebec, Canada

  • Hunan Cancer Hospital

    Changsha, China

  • Hyogo Cancer Center

    Akashi-shi, Japan

  • Institut Bergonie

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie Paris Et Saint Cloud

    Paris, France

  • Institut Gustave Roussy

    Villejuif, France

  • Instituto do Câncer de São Paulo

    São Paulo, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alagre

    Porto Alegre, Brazil

  • Istituto Europeo di Oncologia

    Milan, Italy

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples, Italy

  • Istituto Oncologico Veneto Irccs

    Padova, Italy

  • Istituto Regina Elena-Polo Oncologico Ifo

    Roma, Italy

  • JINAN, Qi Lu Hosp. of SD Univ.

    Jinan, China

  • Jilin Provincial Cancer Hospital

    Changchun, China

  • Johann-Wolfgang Goethe-Universität

    Frankfurt, Germany

  • Johns Hopkins

    Baltimore, Maryland, United States

  • Juravinski Cancer Centre

    Hamilton, Ontario, Canada

  • Kindai University Hospital

    Osakasayama-shi, Japan

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

    Essen, Germany

  • Klinikum rechts der Isar der Technischen Universität

    München, Germany

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, Russia

  • London Health Sciences Centre

    London, Ontario, Canada

  • MD Anderson at Cooper Cancer Center

    Voorhees Township, New Jersey, United States

  • Maastricht Universitair Medisch Centrum

    Maastricht, Netherlands

  • Madrid, H.C.S.Carlos,Oncología

    Madrid, Spain

  • Madrid,H.12 de Octubre,Oncología

    Madrid, Spain

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Mercy Hospital for Women

    Heidelberg, Australia

  • National Cancer Center Hospital

    Chūōku, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Japan

  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

    Amsterdam, Netherlands

  • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

    Grzepnica, Poland

  • Niigata University Medical and Dental Hospital

    Niigata, Japan

  • North Shore University

    Evanston, Illinois, United States

  • OSU JamesCare at Mill Run

    Hilliard, Ohio, United States

  • Onkologie Ravensburg

    Ravensburg, Germany

  • Palo Alto Foundation Medical Group

    San Francisco, California, United States

  • Policlinico Universitario A. Gemelli

    Roma, Italy

  • Prince of Wales Hospital

    Randwick, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • Rambam Health Care Campus

    Haifa, Israel

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Shanghai, 200011, China

  • Royal Marsden Hospital

    London, United Kingdom

  • Royal Marsden Hospital and Institute of Cancer Research

    Sutton, United Kingdom

  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn, Poland

  • Saitama Medical University International Medical Center

    Hidaka-shi, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Sapir Medical Centre

    Kfar Saba, Israel

  • Seoul National University Hospital

    Seoul, South Korea

  • Shanghai Cancer Hospital of Fudan University

    Shanghai, China

  • Shizuoka Cancer Center

    Sunto-gun, Japan

  • St.Petersburg City Oncology Dispensary, Dept. Gynecology

    Saint Petersburg, Russia

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, Canada

  • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

    Warsaw, Poland

  • Tel Hashomer

    Ramat Gan, Israel

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The Hospital of Central Connecticut

    New Britain, Connecticut, United States

  • The Royal Womens Hospital

    Parkville, Australia

  • The Tumor Hospital affiliated to China Medical Science Insti

    Beijing, China

  • The Tumour Hospital of Harbin Medical University

    Harbin, China

  • U.Z. Gent

    Ghent, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, Belgium

  • Universitair Medisch Centrum St. Radboud

    Nijmegen, Netherlands

  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • University of Colorado

    Aurora, Colorado, United States

  • Universitätsklinikum Rostock

    Rostock, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Germany

  • Valencia, IVO, Oncología

    Valencia, Spain

  • Valencia,H.C.U.Valencia,Oncología

    Valencia, Spain

  • West China Hospital Affiliated to Sichuan University

    Chengdu, China

  • Winthrop Gynecologic Oncology Associates

    Mineola, New York, United States

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, Poland

  • Women's Hospital, Zhejaing University School of Medicine

    Hangzhou, China

  • Womens Cancer Care Associates

    Albany, New York, United States

  • Zhejiang Cancer Hospital, Huangzhou

    Huangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.