Platinum SensitivePhase 3NCT01874353
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
A Phase 3 study testing Olaparib 300mg tablets in people with Platinum Sensitive and BRCA Mutated, run by AstraZeneca at 126 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer
- 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
- 327 participants
- Where
- 126 sitesin 17 countries
- Study dates
- 3 Sep 2013to 31 Dec 2026
- Phase
- Phase 3
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
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
126 sites in 17 countries.
126 sites in 17 countries
United States16 sites
Womens Cancer Care Associates
Albany, New York
University of Colorado
Aurora, Colorado
Greater Baltimore Medical Center
Baltimore, Maryland
Johns Hopkins
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Dana Farber Cancer Institute
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
North Shore University
Evanston, Illinois
OSU JamesCare at Mill Run
Hilliard, Ohio
Aurora St Lukes Medical Center
Milwaukee, Wisconsin
Winthrop Gynecologic Oncology Associates
Mineola, New York
Henry Joyce Cancer Clinic
Nashville, Tennessee
The Hospital of Central Connecticut
New Britain, Connecticut
Gynecologic Cancer Center
Orlando, Florida
Palo Alto Foundation Medical Group
San Francisco, California
MD Anderson at Cooper Cancer Center
Voorhees Township, New Jersey
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
Research Site
Shanghai, 200011
Shanghai Cancer Hospital of Fudan University
Shanghai
The First Affiliated Hospital of Soochow University
Suzhou
First affiliated hospital college of XianJiaotong University
Xi'an
France12 sites
Institut Bergonie
Bordeaux
CAC François Baclesse
Caen
69LYON, C Bérard, Onco
Lyon
Centre Catherine de Sienne
Nantes
75PARIS, H Tenon, Onco
Paris
Hopital Européen Georges Pompidou
Paris
Institut Curie Paris Et Saint Cloud
Paris
69PIERREBE, CH Lyon Sud,
Pierre-Bénite
92STCLOUD, C Huguenin, Onco
Saint-Cloud
Institut Claudius Regaud
Toulouse
Centre Alexis Vautrin
Vandœuvre-lès-Nancy
Institut Gustave Roussy
Villejuif
Brazil10 sites
Centro Diagnóstico Barretos
Barretos
Centro Regional Integrado de Oncologia
Fortaleza
Hospital Araujo Jorge
Goiânia
Hospital de Caridade de Ijuí
Ijuí
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
Germany9 sites
Helios-Kliniken Berlin - Buch
Berlin
Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
Essen
Johann-Wolfgang Goethe-Universität
Frankfurt
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Schleswig-Holstein
Lübeck
Klinikum rechts der Isar der Technischen Universität
München
Onkologie Ravensburg
Ravensburg
Universitätsklinikum Rostock
Rostock
Japan9 sites
Hyogo Cancer Center
Akashi-shi
National Cancer Center Hospital
Chūōku
National Hospital Organization Kyushu Cancer Center
Fukuoka
Saitama Medical University International Medical Center
Hidaka-shi
National Hospital Organization Shikoku Cancer Center
Matsuyama
Niigata University Medical and Dental Hospital
Niigata
Kindai University Hospital
Osakasayama-shi
Hokkaido University Hospital
Sapporo
Shizuoka Cancer Center
Sunto-gun
Spain9 sites
Barcelona,H.Clinic i Provincial,Oncología
Barcelona
Barcelona,H.de la Sta.Creu i S.Pau,Oncología
Barcelona
Córdoba,H.Reina Sofía,Oncología
Córdoba
Gerona,H.Josep Trueta,Oncología
Girona
Madrid, H.C.S.Carlos,Oncología
Madrid
Madrid,H.12 de Octubre,Oncología
Madrid
Hospital Provincial de Navarra
Pamplona
Valencia, IVO, Oncología
Valencia
Valencia,H.C.U.Valencia,Oncología
Valencia
United Kingdom8 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
The Christie NHS Foundation Trust
Manchester
Royal Marsden Hospital and Institute of Cancer Research
Sutton
Canada7 sites
Juravinski Cancer Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
CHUM - Hopital Norte-Dame
Montreal, Quebec
Hotel-Dieu de Quebec
Québec, Quebec
CHUS Site Fleurimont
Sherbrooke, Quebec
Princess Margaret Cancer Centre
Toronto, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario
Italy6 sites
Istituto Europeo di Oncologia
Milan
Azienda Ospedaliera Policlinico Di Modena
Modena
Istituto Nazionale Tumori Fondazione Pascale
Naples
Istituto Oncologico Veneto Irccs
Padova
Istituto Regina Elena-Polo Oncologico Ifo
Roma
Policlinico Universitario A. Gemelli
Roma
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
Netherlands4 sites
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
Amsterdam
Maastricht Universitair Medisch Centrum
Maastricht
Universitair Medisch Centrum St. Radboud
Nijmegen
Erasmus Medisch Centrum
Rotterdam
South Korea4 sites
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Australia3 sites
Mercy Hospital for Women
Heidelberg
The Royal Womens Hospital
Parkville
Prince of Wales Hospital
Randwick
Israel3 sites
Rambam Health Care Campus
Haifa
Sapir Medical Centre
Kfar Saba
Tel Hashomer
Ramat Gan
Russia3 sites
Chemotherapy Department, Russian Cancer Research Centre
Moscow
Leningrad Regional Oncology Dispensary
Saint Petersburg
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg
About this study
Official title: 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
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.
Read the detailed description
Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.
- Conditions
- Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy
- Being tested
- Olaparib 300mg tablets, Placebo to match olaparib 300mg
- Keywords
- BRCA, Ovarian cancer, Chemotherapy, PARP Inhibitor, Platinum sensitive
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib 300mg tabletsDrug
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.
Placebo to match olaparib 300mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Olaparib 300mg tablets | Experimental | Taken orally twice daily Receives: Drug: Olaparib 300mg tablets |
| Placebo tablets | Placebo comparator | Taken orally twice daily Receives: Drug: Placebo to match olaparib 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To determine the efficacy 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 by assessment of overall survival (OS).
Measured: 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
To determine the efficacy 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 by assessment of time to earliest progression by RECIST or CA-125 or death.
Measured: 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
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression
Measured: 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)
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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Measured: 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)
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 randomization to first subsequent therapy or death (TFST).
Measured: 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.
Efficacy of Olaparib by 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 randomization to second subsequent therapy or death (TSST).
Measured: Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Efficacy of Olaparib by 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 randomization to study treatment discontinuation or death (TDT).
Measured: Time elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
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 future BRCA mutation assays (gene sequencing and large rearrangement analysis).
Measured: Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy
Measured: Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study start3 Sep 2013
- Primary completion19 Sep 2016
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Platinum SensitiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Professor E Pujade-Lauraine, MD, PhD, Principal investigator, Universite de Paris Descartes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874353
- Sponsor's protocol ID
- D0816C00002
- Other IDs
- 2013-001211-75
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2013
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Ledermann JA, Lortholary A, Penson RT, Asher R, Gebski V, Provencher D, Bruchim I, Huzarski T, Barretina-Ginesta MP, Pipitone S, Mileshkin L, Colombo N, Park-Simon TW, Matsumoto K, Boere I, Mikheeva O, Kim JW, Girotto G, Vergote I, Carter D, Lowe ES, Pujade-Lauraine E. Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trial. Int J Gynecol Cancer. 2026 May;36(5):104556. doi: 10.1016/j.ijgc.2026.104556. Epub 2026 Mar 2.
PubMed 41861615Barnicle 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 39695768Frenel 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.
PubMed 35772665Tattersall 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 35170751Poveda 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.
PubMed 33743851Tjokrowidjaja 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.
PubMed 32977221Friedlander 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.
PubMed 30026002Pujade-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.
PubMed 28754483