Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1)

November 24, 2025 updated by: AstraZeneca

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.

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Heidelberg, Australia
        • Mercy Hospital for Women
      • Parkville, Australia
        • The Royal Womens Hospital
      • Randwick, Australia
        • Prince of Wales Hospital
  • Brazil
      • Barretos, Brazil
        • Centro Diagnóstico Barretos
      • Goiânia, Brazil
        • Hospital Araujo Jorge
      • Itajaí, Brazil
        • Centro De Novos Tratamentos Itajai
      • Porto Alegre, Brazil
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Brazil
        • Irmandade da Santa Casa de Misericordia de Porto Alagre
      • São José do Rio Preto, Brazil
        • Hospital de Base São José do Rio Preto
      • São Paulo, Brazil
        • Centro de Referencia da Saude da Mulher
      • São Paulo, Brazil
        • Instituto do Câncer de São Paulo
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • CHUM - Hopital Norte-Dame
      • Québec, Quebec, Canada
        • Hotel-Dieu de Quebec
  • China
      • Beijing, China
        • Beijing Cancer Hospital
      • Beijing, China
        • The Tumor Hospital affiliated to China Medical Science Insti
      • Changchun, China
        • 1st Hospital of Jilin University
      • Changchun, China
        • Jilin Provincial Cancer Hospital
      • Changsha, China
        • Hunan Cancer Hospital
      • Chengdu, China
        • West China Hospital Affiliated to Sichuan University
      • Chongqing, China
        • Chongqing Cancer Hospital
      • Guangzhou, China, 510060
        • Research Site
      • Hangzhou, China
        • Women's Hospital, Zhejaing University School of Medicine
      • Harbin, China
        • The Tumour Hospital of Harbin Medical University
      • Huangzhou, China
        • Zhejiang Cancer Hospital, Huangzhou
      • Jinan, China
        • JINAN, Qi Lu Hosp. of SD Univ.
      • Shanghai, China
        • Shanghai Cancer Hospital of Fudan University
      • Shanghai, China
        • Obstetris and Gynecology Hospital of Fudan University
      • Suzhou, China
        • The First Affiliated Hospital of Soochow Universit
      • Xi'an, China
        • First affiliated hospital college of XianJiaotong University
  • France
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • CAC François Baclesse
      • Lyon, France
        • 69LYON, C Bérard, Onco
      • Nantes, France
        • Centre Catherine de Sienne
      • Paris, France
        • 75PARIS, H Tenon, Onco
      • Vandœuvre-lès-Nancy, France
        • Centre Alexis Vautrin
      • Villejuif, France
        • Institut Gustave Roussy
  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus
      • Kfar Saba, Israel
        • Sapir Medical Centre
      • Petah Tikva, Israel
        • Rabin MC
      • Tel Aviv, Israel
        • Tel-Aviv Sourkasy Medical Center
      • Tel Litwinsky, Israel
        • Chaim Sheba Medical Centre
  • Italy
      • Bari, Italy
        • Bari- Istituto Tumori Giovanni Paolo II
      • Catania, Italy
        • Azienda Ospedaliera "Cannizzaro"
      • Milan, Italy
        • Istituto Europeo di Oncologia
      • Milan, Italy
        • Istituto Nazionale Per Cura Tumori - Milano
      • Napoli, Italy
        • Istituto Nazionale Tumori Fondazione Pascale
      • Padua, Italy
        • Istituto Oncologico Veneto IRCCS
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Roma, Italy
        • Istituto Regina Elena-Polo Oncologico Ifo
  • Japan
      • Akashi-shi, Japan
        • Hyogo CC
      • Chūōku, Japan
        • National Cancer Center Hosp
      • Fukuoka, Japan
        • NHO Kyushu CC
      • Hidaka-shi, Japan
        • Saitama Med. Univ. Int. Med. C
      • Matsuyama, Japan
        • NHO Shikoku Cancer Center
      • Niigata, Japan
        • Niigata Univ. Med. Dent.
      • Sapporo, Japan
        • Hokkaido University Hospital
      • Sunto-gun, Japan
        • Shizuoka Cancer Center
  • Netherlands
      • Amsterdam, Netherlands
        • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
      • Maastricht, Netherlands
        • Maastricht Universitair Medisch Centrum
  • Poland
      • Grzepnica, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
      • Olsztyn, Poland
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
      • Olsztyn, Poland
        • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
      • Warsaw, Poland
        • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
      • Warsaw, Poland
        • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
  • Russia
      • Izhevsk, Russia
        • Udmurtia Republic Clinical Oncology Center
      • Moscow, Russia
        • Chemotherapy Department, Russian Cancer Research Centre
      • Omsk, Russia
        • State Institution of Heath Omsk Regional Oncology Dispensary
      • Saint Petersburg, Russia
        • Cancer Research Institute
      • Saint Petersburg, Russia
        • Leningrad Regional Oncology Dispensary
      • Saint Petersburg, Russia
        • St.Petersburg City Oncology Dispensary, Dept. Gynecology
      • Tomsk, Russia
        • Research Institute of Oncology RAMS
  • South Korea
      • Goyang-si, South Korea
        • National Cancer Center
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Gangnam Severance Hospital
      • Seoul, South Korea
        • Korea Cancer Center Hospital
  • Spain
      • Barcelona, Spain
        • Barcelona,H.Vall d´Hebrón,Oncología
      • Córdoba, Spain
        • Córdoba,H.Reina Sofía,Oncología
      • Hospitalet deLlobregat(Barcelo, Spain
        • H.Llobregat,ICO-Duran i Reynals,Oncología
      • Madrid, Spain
        • Madrid, MD Anderson, Oncología
      • Madrid, Spain
        • Madrid,H.U.La Paz,Oncología
      • Valencia, Spain
        • Valencia, IVO, Oncología
      • Valencia, Spain
        • Valencia,H.C.U.Valencia,Oncología
  • United Kingdom
      • Birmingham, United Kingdom
        • City Hospital, Birmingham, Cancer Trials Team
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Coventry, United Kingdom
        • Arden Cancer Centre
      • Edinburgh, United Kingdom
        • Edinburgh Cancer Research UK Centre
      • London, United Kingdom
        • Royal Marsden Hospital
      • London, United Kingdom
        • Cancer Research UK and UCL Cancer Trials Centre
      • Sutton, United Kingdom
        • Royal Marsden Hospital and Institute of Cancer Research
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Clearview Cancer Institute
    • Alaska
      • Anchorage, Alaska, United States
        • Providence Cancer Center
    • Arizona
      • Phoenix, Arizona, United States
        • St. Joseph's Hospital & Medical Center
    • California
      • Los Angeles, California, United States
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States
        • University of California, Los Angeles
      • Oakland, California, United States
        • Kaiser Permanente
      • Roseville, California, United States
        • Kaiser Permanente
      • Stanford, California, United States
        • Stanford Women's Cancer Center
      • Walnut Creek, California, United States
        • Babak Edraki
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado
    • Connecticut
      • Farmington, Connecticut, United States
        • Univ of Connecticut Health Center
      • New Haven, Connecticut, United States
        • Smilow Cancer Hospital at Yale New Haven
    • Florida
      • Orlando, Florida, United States
        • Gynecologic Cancer Center
      • Orlando, Florida, United States
        • Florida Hospital Cancer Institute
      • Tampa, Florida, United States
        • H Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Northside Hospital
      • Gainesville, Georgia, United States
        • Northeast Georgia Medical Center
      • Savannah, Georgia, United States
        • Nancy N. & J.C. Lewis Cancer and Research Pavillion
    • Hawaii
      • Honolulu, Hawaii, United States
        • University of Hawaii
      • Honolulu, Hawaii, United States
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • Univ Chicago Medical Center
      • Park Ridge, Illinois, United States
        • Advocate Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University
      • Indianapolis, Indiana, United States
        • St. Vincent Hospital & Health Care Center
      • Mishawaka, Indiana, United States
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Ames, Iowa, United States
        • McFarland Clinic, P.C.
    • Kentucky
      • Louisville, Kentucky, United States
        • Norton Cancer Institute Research
    • Maine
      • Scarborough, Maine, United States
        • Maine Medical Partners
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins
      • Baltimore, Maryland, United States
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, United States
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States
        • Gynecologic Oncology of West MI, PLLC
    • Minnesota
      • Edina, Minnesota, United States
        • Minnesota Oncology Hematology, PA
      • Rochester, Minnesota, United States
        • Mayo Clinic - Rochester, Mn
    • Mississippi
      • Jackson, Mississippi, United States
        • University of Mississippi Medical Center
    • Missouri
      • St Louis, Missouri, United States
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States
        • Missouri Valley Cancer Consortium CCOP
    • Nevada
      • Las Vegas, Nevada, United States
        • Womens Cancer Center of Nevada
    • New Jersey
      • Camden, New Jersey, United States
        • MD Anderson at Cooper Cancer Center
      • Hackensack, New Jersey, United States
        • John Theurer Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States
        • University of New Mexico
    • New York
      • Albany, New York, United States
        • Women's Cancer Care Associates
      • Buffalo, New York, United States
        • Roswell Park Cancer Institute
      • New York, 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
    • North Carolina
      • Asheville, North Carolina, United States
        • Hope Women's Cancer Centers
      • Chapel Hill, North Carolina, United States
        • UNC Chapel Hill
      • Charlotte, North Carolina, United States
        • Levine Cancer Institute
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Canton, Ohio, United States
        • Aultman Hospital
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States
        • University Hospital Case Medical Center
      • Cleveland, Ohio, United States
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, United States, 43210
        • Research Site
      • Kettering, Ohio, United States
        • Kettering Medical Center
      • Mayfield Heights, Ohio, United States
        • Hillcrest Hospital Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Peggy and Charles Stephenson Cancer Center
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Abington Memorial Hospital
      • Bethlehem, Pennsylvania, United States
        • St. Luke's University Health network
      • Philadelphia, Pennsylvania, United States
        • The University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States
        • Women and Infants Hospital
    • South Carolina
      • Columbia, South Carolina, United States
        • South Carolina Oncology Associates, PA
    • South Dakota
      • Sioux Falls, South Dakota, United States
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States
        • Sanford Clinic Women's Health
    • Texas
      • Dallas, Texas, United States
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States
        • MD Anderson Cancer Center
      • Houston, Texas, United States
        • University of Texas Health Science Center of Houston
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
      • Norfolk, Virginia, United States
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States
        • Carilion Clinic Gynecological Oncology
    • Wisconsin
      • Green Bay, Wisconsin, United States
        • Aurora BayCare Medical Center
      • Madison, Wisconsin, United States
        • University of Wisconsin-Madison
      • Milwaukee, Wisconsin, United States
        • Froedtert Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
  • Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
  • 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 completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
  • Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
  • Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

  • BRCA1 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 with early stage disease (FIGO Stage I, IIA, IIB or IIC)
  • Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
  • Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
  • Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
  • Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
  • Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olaparib tablets p.o. 300mg twice daily
Olaparib/placebo tablets p.o 300mg twice daily for up to 3 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
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.
Placebo Comparator: Placebo tablets p.o. twice daily
Olaparib/placebo tablets p.o 300mg twice daily for up to 3 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Time Frame: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Time Frame: Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS
Time Frame: Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.
To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)
Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
Time Frame: Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.
Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
Time Frame: CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death
CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Time Frame: Following first progression disease then assessed per local practice every 12 weeks until second progression.
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second progression (PFS2)
Following first progression disease then assessed per local practice every 12 weeks until second progression.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
Time Frame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)
Time Frame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)
Time Frame: Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Merck Sharp & Dohme LLC
GOG Foundation
Myriad Genetic Laboratories, Inc.

Investigators

  • Principal Investigator: Prof Paul DiSilvestro, MD, Women & Infants Hospital, Providence, Rhode Island, USA
  • Principal Investigator: Prof Kathleen Moore, MD, University of Oklahoma Health Sciences Center, Oklahoma City, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2013

Primary Completion (Actual)

May 17, 2018

Study Completion (Estimated)

August 29, 2028

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimated)

May 3, 2013

Study Record Updates

Last Update Posted (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0818C00001
  • 2013-001551-13 (EudraCT Number)
  • 2024-511142-39-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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