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

NCT ID: NCT01844986

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-26
• Study Completion Date: 2028-08-29

Brief Summary

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

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.

Conditions

Newly Diagnosed; Advanced Ovarian Cancer; FIGO Stage III-IV; BRCA Mutation; Complete Response; Partial Response; First Line Platinum Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Olaparib 300mg tablets

Intervention Type: DRUG

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 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

Group Type: PLACEBO_COMPARATOR

Olaparib 300mg tablets

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GOG Foundation

NETWORK

Sponsor Role: collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Paul DiSilvestro, MD

Role: PRINCIPAL_INVESTIGATOR

Women & Infants Hospital, Providence, Rhode Island, USA

Prof Kathleen Moore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Sciences Center, Oklahoma City, USA

Locations

Clearview Cancer Institute

Huntsville, Alabama, United States

Providence Cancer Center

Anchorage, Alaska, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

Kaiser Permanente

Roseville, California, United States

Stanford Women's Cancer Center

Stanford, California, United States

Babak Edraki

Walnut Creek, California, United States

University of Colorado

Aurora, Colorado, United States

Univ of Connecticut Health Center

Farmington, Connecticut, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Gynecologic Cancer Center

Orlando, Florida, United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

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

Savannah, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

University of Hawaii

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Univ Chicago Medical Center

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Vincent Hospital & Health Care Center

Indianapolis, Indiana, United States

Northern Indiana Cancer Research Consortium

Mishawaka, Indiana, United States

McFarland Clinic, P.C.

Ames, Iowa, United States

Norton Cancer Institute Research

Louisville, Kentucky, United States

Maine Medical Partners

Scarborough, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Gynecologic Oncology of West MI, PLLC

Grand Rapids, Michigan, United States

Minnesota Oncology Hematology, PA

Edina, Minnesota, United States

Mayo Clinic - Rochester, MN

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Valley Cancer Consortium CCOP

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Womens Cancer Center of Nevada

Las Vegas, Nevada, United States

MD Anderson at Cooper Cancer Center

Camden, New Jersey, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Women's Cancer Care Associates

Albany, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Mount Sinai Medical Center - New York

New York, New York, United States

Perlmutter Cancer Center

New York, New York, United States

Hope Women's Cancer Centers

Asheville, North Carolina, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Aultman Hospital

Canton, Ohio, United States

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University Hospital Case Medical Center

Cleveland, Ohio, United States

Research Site

Columbus, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Sanford Clinic Women's Health

Sioux Falls, South Dakota, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center of Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, United States

Aurora Baycare Medical Center

Green Bay, Wisconsin, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Froedtert Memorial Hospital

Milwaukee, Wisconsin, United States

Mercy Hospital for Women

Heidelberg, , Australia

The Royal Womens Hospital

Parkville, , Australia

Prince of Wales Hospital

Randwick, , Australia

Centro Diagnóstico Barretos

Barretos, , Brazil

Hospital Araujo Jorge

Goiânia, , Brazil

Centro de Novos Tratamentos Itajai

Itajaí, , Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, , Brazil

Irmandade da Santa Casa de Misericordia de Porto Alagre

Porto Alegre, , Brazil

Hospital de Base São José do Rio Preto

São José do Rio Preto, , Brazil

Centro de Referencia da Saude da Mulher

São Paulo, , Brazil

Instituto do Câncer de São Paulo

São Paulo, , Brazil

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

CHUM - Hopital Norte-Dame

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

Beijing Cancer Hospital

Beijing, , China

The Tumor Hospital affiliated to China Medical Science Insti

Beijing, , China

1st Hospital of Jilin university

Changchun, , China

Jilin Provincial Cancer Hospital

Changchun, , China

Hunan Cancer Hospital

Changsha, , China

West China Hospital Affiliated to Sichuan University

Chengdu, , China

ChongQing Cancer Hospital

Chongqing, , China

Research Site

Guangzhou, , China

Women's Hospital, Zhejaing University School of Medicine

Hangzhou, , China

The Tumour Hospital of Harbin Medical University

Harbin, , China

Zhejiang Cancer Hospital, Huangzhou

Huangzhou, , China

JINAN, Qi Lu Hosp. of SD Univ.

Jinan, , China

Obstetris and Gynecology Hospital of Fudan University

Shanghai, , China

Shanghai Cancer Hospital of Fudan University

Shanghai, , China

The First Affiliated Hospital of Soochow Universit

Suzhou, , China

First affiliated hospital college of XianJiaotong University

Xi'an, , China

Institut Bergonie

Bordeaux, , France

CAC François Baclesse

Caen, , France

69LYON, C Bérard, Onco

Lyon, , France

Centre Catherine de Sienne

Nantes, , France

75PARIS, H Tenon, Onco

Paris, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Rambam Health Care Campus

Haifa, , Israel

Sapir Medical Centre

Kfar Saba, , Israel

Rabin MC

Petah Tikva, , Israel

Tel-Aviv Sourkasy Medical Center

Tel Aviv, , Israel

Chaim Sheba Medical Centre

Tel Litwinsky, , Israel

Bari- Istituto Tumori Giovanni Paolo II

Bari, , Italy

Azienda Ospedaliera "Cannizzaro"

Catania, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

Istituto Nazionale Per Cura Tumori - Milano

Milan, , Italy

Istituto Nazionale Tumori Fondazione Pascale

Napoli, , Italy

Istituto Oncologico Veneto Irccs

Padua, , Italy

Istituto Regina Elena-Polo Oncologico Ifo

Roma, , Italy

Policlinico Universitario A. Gemelli

Roma, , Italy

Hyogo CC

Akashi-shi, , Japan

National Cancer Center Hosp

Chūōku, , Japan

NHO Kyushu CC

Fukuoka, , Japan

Saitama Med. Univ. Int. Med. C

Hidaka-shi, , Japan

NHO Shikoku Cancer Center

Matsuyama, , Japan

Niigata Univ. Med. Dent.

Niigata, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Shizuoka Cancer Center

Sunto-gun, , Japan

Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, , Netherlands

Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

Grzepnica, , Poland

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, , Poland

Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, , Poland

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

Warsaw, , Poland

Udmurtia Republic Clinical Oncology Center

Izhevsk, , Russia

Chemotherapy Department, Russian Cancer Research Centre

Moscow, , Russia

State Institution of Heath Omsk Regional Oncology Dispensary

Omsk, , Russia

Cancer Research Institute

Saint Petersburg, , Russia

Leningrad Regional Oncology Dispensary

Saint Petersburg, , Russia

St.Petersburg City Oncology Dispensary, Dept. Gynecology

Saint Petersburg, , Russia

Research Institute of Oncology RAMS

Tomsk, , Russia

National Cancer Center

Goyang-si, , South Korea

Asan Medical Center

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Korea Cancer Center Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Barcelona,H.Vall d´Hebrón,Oncología

Barcelona, , Spain

Córdoba,H.Reina Sofía,Oncología

Córdoba, , Spain

H.Llobregat,ICO-Duran i Reynals,Oncología

Hospitalet deLlobregat(Barcelo, , Spain

Madrid, MD Anderson, Oncología

Madrid, , Spain

Madrid,H.U.La Paz,Oncología

Madrid, , Spain

Valencia, IVO, Oncología

Valencia, , Spain

Valencia,H.C.U.Valencia,Oncología

Valencia, , Spain

City Hospital, Birmingham, Cancer Trials Team

Birmingham, , United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

Arden Cancer Centre

Coventry, , United Kingdom

Edinburgh Cancer Research UK Centre

Edinburgh, , United Kingdom

Cancer Research UK and UCL Cancer Trials Centre

London, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Royal Marsden Hospital and Institute of Cancer Research

Sutton, , United Kingdom

Countries

United States; Australia; Brazil; Canada; China; France; Israel; Italy; Japan; Netherlands; Poland; Russia; South Korea; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39695768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36082969 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

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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.

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Clinical%20Study%20Protocol.pdf

Redacted Clinical Study Protocol

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Statistical%20Analysis%20Plan.pdf

Redacted Statistical Analysis Plan

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Statistiacal%20Analysis%20Plan..pdf

Redacted Statistical Analysis Plan

Other Identifiers

2024-511142-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-001551-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D0818C00001

Identifier Type: -

Identifier Source: org_study_id