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Newly DiagnosedPhase 3SOLO-1NCT01844986

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

A Phase 3 study testing Olaparib 300mg tablets in people with Newly Diagnosed and Advanced Ovarian Cancer, run by AstraZeneca at 177 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy. Read more about this study

Who is it for?
Ages 18 to 130 years, women only
What is being tested?
Olaparib 300mg tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
177 sitesin 15 countries
Study dates
26 Aug 2013to 29 Aug 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 15 countries.

177 sites in 15 countries

United States81 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania

  • Women's Cancer Care Associates

    Albany, New York

  • University of New Mexico

    Albuquerque, New Mexico

  • McFarland Clinic, P.C.

    Ames, Iowa

  • Providence Cancer Center

    Anchorage, Alaska

  • Hope Women's Cancer Centers

    Asheville, North Carolina

  • Northside Hospital

    Atlanta, Georgia

  • University of Colorado

    Aurora, Colorado

  • Greater Baltimore Medical Center

    Baltimore, Maryland

  • Johns Hopkins

    Baltimore, Maryland

  • Walter Reed National Military Medical Center

    Bethesda, Maryland

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts

  • Dana Farber Cancer Institute

    Boston, Massachusetts

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Roswell Park Cancer Institute

    Buffalo, New York

  • MD Anderson at Cooper Cancer Center

    Camden, New Jersey

  • Aultman Hospital

    Canton, Ohio

  • UNC Chapel Hill

    Chapel Hill, North Carolina

  • Levine Cancer Institute

    Charlotte, North Carolina

  • University of Virginia

    Charlottesville, Virginia

  • Northwestern University

    Chicago, Illinois

  • Univ Chicago Medical Center

    Chicago, Illinois

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • University Hospital Case Medical Center

    Cleveland, Ohio

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina

  • Research Site

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas

  • Henry Ford Health System

    Detroit, Michigan

  • Duke University Medical Center

    Durham, North Carolina

  • Minnesota Oncology Hematology, PA

    Edina, Minnesota

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota

  • Univ of Connecticut Health Center

    Farmington, Connecticut

  • Northeast Georgia Medical Center

    Gainesville, Georgia

  • Gynecologic Oncology of West MI, PLLC

    Grand Rapids, Michigan

  • Aurora Baycare Medical Center

    Green Bay, Wisconsin

  • John Theurer Cancer Center

    Hackensack, New Jersey

  • The Queen's Medical Center

    Honolulu, Hawaii

  • University of Hawaii

    Honolulu, Hawaii

  • MD Anderson Cancer Center

    Houston, Texas

  • University of Texas Health Science Center of Houston

    Houston, Texas

  • Clearview Cancer Institute

    Huntsville, Alabama

  • Indiana University

    Indianapolis, Indiana

  • St. Vincent Hospital & Health Care Center

    Indianapolis, Indiana

  • University of Mississippi Medical Center

    Jackson, Mississippi

  • Kettering Medical Center

    Kettering, Ohio

  • Womens Cancer Center of Nevada

    Las Vegas, Nevada

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • University of California, Los Angeles

    Los Angeles, California

  • Norton Cancer Institute Research

    Louisville, Kentucky

  • University of Wisconsin-Madison

    Madison, Wisconsin

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio

  • Froedtert Memorial Hospital

    Milwaukee, Wisconsin

  • Northern Indiana Cancer Research Consortium

    Mishawaka, Indiana

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut

  • Memorial Sloan Kettering Cancer Center

    New York, New York

  • Mount Sinai Medical Center - New York

    New York, New York

  • Perlmutter Cancer Center

    New York, New York

  • Virginia Oncology Associates

    Norfolk, Virginia

  • Kaiser Permanente

    Oakland, California

  • Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma

  • Missouri Valley Cancer Consortium CCOP

    Omaha, Nebraska

  • Nebraska Methodist Hospital

    Omaha, Nebraska

  • Florida Hospital Cancer Institute

    Orlando, Florida

  • Gynecologic Cancer Center

    Orlando, Florida

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois

  • The University of Pennsylvania

    Philadelphia, Pennsylvania

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona

  • Women and Infants Hospital

    Providence, Rhode Island

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia

  • Mayo Clinic - Rochester, MN

    Rochester, Minnesota

  • Kaiser Permanente

    Roseville, California

  • Nancy N. & J.C. Lewis Cancer and Research Pavillion

    Savannah, Georgia

  • Maine Medical Partners

    Scarborough, Maine

  • Avera Cancer Institute

    Sioux Falls, South Dakota

  • Sanford Clinic Women's Health

    Sioux Falls, South Dakota

  • Washington University School of Medicine

    St Louis, Missouri

  • Stanford Women's Cancer Center

    Stanford, California

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida

  • Babak Edraki

    Walnut Creek, California

Other trials in United States

China16 sites

  • Beijing Cancer Hospital

    Beijing

  • The Tumor Hospital affiliated to China Medical Science Insti

    Beijing

  • 1st Hospital of Jilin university

    Changchun

  • Jilin Provincial Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital Affiliated to Sichuan University

    Chengdu

  • ChongQing Cancer Hospital

    Chongqing

  • Research Site

    Guangzhou, 510060

  • Women's Hospital, Zhejaing University School of Medicine

    Hangzhou

  • The Tumour Hospital of Harbin Medical University

    Harbin

  • Zhejiang Cancer Hospital, Huangzhou

    Huangzhou

  • JINAN, Qi Lu Hosp. of SD Univ.

    Jinan

  • Obstetris and Gynecology Hospital of Fudan University

    Shanghai

  • Shanghai Cancer Hospital of Fudan University

    Shanghai

  • The First Affiliated Hospital of Soochow Universit

    Suzhou

  • First affiliated hospital college of XianJiaotong University

    Xi'an

Other trials in China

Brazil8 sites

  • Centro Diagnóstico Barretos

    Barretos

  • Hospital Araujo Jorge

    Goiânia

  • Centro de Novos Tratamentos Itajai

    Itajaí

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre

  • Irmandade da Santa Casa de Misericordia de Porto Alagre

    Porto Alegre

  • Hospital de Base São José do Rio Preto

    São José do Rio Preto

  • Centro de Referencia da Saude da Mulher

    São Paulo

  • Instituto do Câncer de São Paulo

    São Paulo

Other trials in Brazil

Italy8 sites

  • Bari- Istituto Tumori Giovanni Paolo II

    Bari

  • Azienda Ospedaliera "Cannizzaro"

    Catania

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Per Cura Tumori - Milano

    Milan

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples

  • Istituto Oncologico Veneto Irccs

    Padova

  • Istituto Regina Elena-Polo Oncologico Ifo

    Roma

  • Policlinico Universitario A. Gemelli

    Roma

Other trials in Italy

Japan8 sites

  • Hyogo CC

    Akashi-shi

  • National Cancer Center Hosp

    Chūōku

  • NHO Kyushu CC

    Fukuoka

  • Saitama Med. Univ. Int. Med. C

    Hidaka-shi

  • NHO Shikoku Cancer Center

    Matsuyama

  • Niigata Univ. Med. Dent.

    Niigata

  • Hokkaido University Hospital

    Sapporo

  • Shizuoka Cancer Center

    Sunto-gun

Other trials in Japan

Canada7 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • London Health Sciences Centre

    London, Ontario

  • CHUM - Hopital Norte-Dame

    Montreal, Quebec

  • Royal Victoria Hospital

    Montreal, Quebec

  • Hotel-Dieu de Quebec

    Québec, Quebec

  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • Sunnybrook Health Sciences Center

    Toronto, Ontario

Other trials in Canada

France7 sites

  • Institut Bergonie

    Bordeaux

  • CAC François Baclesse

    Caen

  • 69LYON, C Bérard, Onco

    Lyon

  • Centre Catherine de Sienne

    Nantes

  • 75PARIS, H Tenon, Onco

    Paris

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Russia7 sites

  • Udmurtia Republic Clinical Oncology Center

    Izhevsk

  • Chemotherapy Department, Russian Cancer Research Centre

    Moscow

  • State Institution of Heath Omsk Regional Oncology Dispensary

    Omsk

  • Cancer Research Institute

    Saint Petersburg

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg

  • St.Petersburg City Oncology Dispensary, Dept. Gynecology

    Saint Petersburg

  • Research Institute of Oncology RAMS

    Tomsk

Other trials in Russia

Spain7 sites

  • Barcelona,H.Vall d´Hebrón,Oncología

    Barcelona

  • Córdoba,H.Reina Sofía,Oncología

    Córdoba

  • H.Llobregat,ICO-Duran i Reynals,Oncología

    Hospitalet deLlobregat(Barcelo

  • Madrid, MD Anderson, Oncología

    Madrid

  • Madrid,H.U.La Paz,Oncología

    Madrid

  • Valencia, IVO, Oncología

    Valencia

  • Valencia,H.C.U.Valencia,Oncología

    Valencia

Other trials in Spain

United Kingdom7 sites

  • City Hospital, Birmingham, Cancer Trials Team

    Birmingham

  • Addenbrooke's Hospital

    Cambridge

  • Arden Cancer Centre

    Coventry

  • Edinburgh Cancer Research UK Centre

    Edinburgh

  • Cancer Research UK and UCL Cancer Trials Centre

    London

  • Royal Marsden Hospital

    London

  • Royal Marsden Hospital and Institute of Cancer Research

    Sutton

Other trials in United Kingdom

South Korea6 sites

  • National Cancer Center

    Goyang-si

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Korea Cancer Center Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Israel5 sites

  • Rambam Health Care Campus

    Haifa

  • Sapir Medical Centre

    Kfar Saba

  • Rabin MC

    Petah Tikva

  • Tel-Aviv Sourkasy Medical Center

    Tel Aviv

  • Chaim Sheba Medical Centre

    Tel Litwinsky

Other trials in Israel

Poland5 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

    Grzepnica

  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn

  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

    Warsaw

  • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

    Warsaw

Other trials in Poland

Australia3 sites

  • Mercy Hospital for Women

    Heidelberg

  • The Royal Womens Hospital

    Parkville

  • Prince of Wales Hospital

    Randwick

Other trials in Australia

Netherlands2 sites

  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

    Amsterdam

  • Maastricht Universitair Medisch Centrum

    Maastricht

Other trials in Netherlands

About this study

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.

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

Read the 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.

Being tested
Olaparib 300mg tablets
Keywords
BRCA, Ovarian Cancer, Chemotherapy, PARP inhibitor, First Line, FIGO Stage III, FIGO Stage IV
Medical subject headings
Pathologic Complete Response, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaparib 300mg tabletsDrug

    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.

Study groups in NCT01844986
Study groupRoleWhat they receive
Olaparib tablets p.o. 300mg twice dailyExperimentalOlaparib/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
Receives: Drug: Olaparib 300mg tablets
Placebo tablets p.o. twice dailyPlacebo comparatorOlaparib/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
Receives: Drug: Olaparib 300mg tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

    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.

    Measured: 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 outcomes (8)

  1. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

    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.

    Measured: 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.

  2. 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

    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

    Measured: 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

  3. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to 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)

    Measured: Following first progression disease then assessed per local practice every 12 weeks until second progression.

  4. 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)

    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.

    Measured: 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

  5. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

    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).

    Measured: 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.

  6. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)

    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).

    Measured: 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.

  7. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)

    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).

    Measured: 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.

  8. Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS

    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)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2013 (estimated)
  2. Study start26 Aug 2013
  3. Primary completion17 May 2018
  4. Study completion29 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844986
Sponsor's protocol ID
D0818C00001
Other IDs
2024-511142-39-00, 2013-001551-13
Acronym
SOLO-1
Status last verified
Nov 2025
First submitted
30 Apr 2013
Last updated
10 Dec 2025
Data monitoring committee
Yes
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.

    PubMed 39695768

  • DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549. Epub 2022 Sep 9.

    PubMed 36082969

  • Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

    PubMed 35170751

  • Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26.

    PubMed 34715071

  • Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.

    PubMed 33862001

  • Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

    PubMed 30345884

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib 300mg tablets in people with Newly Diagnosed and Advanced Ovarian Cancer, run by AstraZeneca at 177 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, China, Brazil, Italy, Japan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01844986, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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