Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
2 other identifiers
interventional
327
17 countries
126
Brief Summary
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2013
Longer than P75 for phase_3
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedStudy Start
First participant enrolled
September 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2016
CompletedResults Posted
Study results publicly available
February 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 3, 2025
July 1, 2025
3 years
June 7, 2013
September 15, 2017
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.
Secondary Outcomes (9)
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths.
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. Assessments then per local practice every 12 wks until second progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths
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)
Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.
Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)
Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
- +4 more secondary outcomes
Study Arms (2)
Olaparib 300mg tablets
EXPERIMENTALTaken orally twice daily
Placebo tablets
PLACEBO COMPARATORTaken orally twice daily
Interventions
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- Myriad Genetic Laboratories, Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (126)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Palo Alto Foundation Medical Group
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Gynecologic Cancer Center
Orlando, Florida, United States
North Shore University
Evanston, Illinois, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson at Cooper Cancer Center
Voorhees Township, New Jersey, United States
Womens Cancer Care Associates
Albany, New York, United States
Winthrop Gynecologic Oncology Associates
Mineola, New York, United States
OSU JamesCare at Mill Run
Hilliard, Ohio, United States
Henry Joyce Cancer Clinic
Nashville, Tennessee, United States
Aurora St Lukes Medical Center
Milwaukee, Wisconsin, United States
Mercy Hospital for Women
Heidelberg, Australia
The Royal Womens Hospital
Parkville, Australia
Prince of Wales Hospital
Randwick, Australia
U.Z. Gent
Ghent, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Centro Diagnóstico Barretos
Barretos, Brazil
Centro Regional Integrado de Oncologia
Fortaleza, Brazil
Hospital Araujo Jorge
Goiânia, Brazil
Hospital de Caridade de Ijuí
Ijuí, 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
Hotel-Dieu de Quebec
Québec, Quebec, Canada
CHUS Site Fleurimont
Sherbrooke, 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, 510060, 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
Research Site
Shanghai, 200011, China
Shanghai Cancer Hospital of Fudan University
Shanghai, China
The First Affiliated Hospital of Soochow University
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
Hopital Européen Georges Pompidou
Paris, France
Institut Curie Paris Et Saint Cloud
Paris, France
69PIERREBE, CH Lyon Sud,
Pierre-Bénite, France
92STCLOUD, C Huguenin, Onco
Saint-Cloud, France
Institut Claudius Regaud
Toulouse, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Helios-Kliniken Berlin - Buch
Berlin, Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen, Germany
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
Essen, Germany
Johann-Wolfgang Goethe-Universität
Frankfurt, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Klinikum rechts der Isar der Technischen Universität
München, Germany
Onkologie Ravensburg
Ravensburg, Germany
Universitätsklinikum Rostock
Rostock, Germany
Rambam Health Care Campus
Haifa, Israel
Sapir Medical Centre
Kfar Saba, Israel
Tel Hashomer
Ramat Gan, Israel
Istituto Europeo di Oncologia
Milan, Italy
Azienda Ospedaliera Policlinico Di Modena
Modena, 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 Cancer Center
Akashi-shi, Japan
National Cancer Center Hospital
Chūōku, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Niigata University Medical and Dental Hospital
Niigata, Japan
Kindai University Hospital
Osakasayama-shi, 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
Universitair Medisch Centrum St. Radboud
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, 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
Chemotherapy Department, Russian Cancer Research Centre
Moscow, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, Russia
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg, Russia
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Barcelona,H.Clinic i Provincial,Oncología
Barcelona, Spain
Barcelona,H.de la Sta.Creu i S.Pau,Oncología
Barcelona, Spain
Córdoba,H.Reina Sofía,Oncología
Córdoba, Spain
Gerona,H.Josep Trueta,Oncología
Girona, Spain
Madrid, H.C.S.Carlos,Oncología
Madrid, Spain
Madrid,H.12 de Octubre,Oncología
Madrid, Spain
Hospital Provincial de Navarra
Pamplona, 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
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Marsden Hospital and Institute of Cancer Research
Sutton, United Kingdom
Related Publications (7)
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.
PMID: 39695768DERIVEDFrenel JS, Kim JW, Aryal N, Asher R, Berton D, Vidal L, Pautier P, Ledermann JA, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Colombo N, Park-Simon TW, Tamura K, Sonke GS, Freimund AE, Lee CK, Pujade-Lauraine E. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol. 2022 Oct;33(10):1021-1028. doi: 10.1016/j.annonc.2022.06.011. Epub 2022 Jun 27.
PMID: 35772665DERIVEDTattersall 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.
PMID: 35170751DERIVEDPoveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18.
PMID: 33743851DERIVEDTjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23.
PMID: 32977221DERIVEDFriedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17.
PMID: 30026002DERIVEDPujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25.
PMID: 28754483DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The outbreak of the COVID-19 pandemic shortly before the final OS DCO (03 February 2020) was not judged to meaningfully impact the overall quality of the study, including the conduct, data, and interpretation of results.
Results Point of Contact
- Title
- Global Clinical Program Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Professor E Pujade-Lauraine, MD, PhD
Universite de Paris Descartes, France
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
September 3, 2013
Primary Completion
September 19, 2016
Study Completion
December 31, 2025
Last Updated
August 3, 2025
Results First Posted
February 7, 2018
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.