Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
SOLO3
A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.
1 other identifier
interventional
266
13 countries
94
Brief Summary
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.
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 Feb 2015
Longer than P75 for phase_3
94 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
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 4, 2014
CompletedStudy Start
First participant enrolled
February 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedResults Posted
Study results publicly available
December 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2022
CompletedJuly 26, 2022
July 1, 2022
3.7 years
October 20, 2014
October 3, 2019
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
To determine the efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Objective Response Rate (ORR) using blinded independent central review (BICR) Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used by a Blinded Independent Central Review (BICR) to assess participant response to treatment ORR is the number of participants with Complete Response (CR) or Partial Response (PR) in the Measurable Disease Analysis Set (MDAS). Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each. Partial response is declared when there is a decrease in sum of diameters of target lesions ≥ 30%.
RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
Secondary Outcomes (20)
Progression Free Survival (PFS)
RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
Time From Randomisation to Second Progression (PFS2)
Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
Overall Survival (OS)
Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or Death
RECIST and CA-125 follow-up assessments performed every 8 weeks (±1week), up to 48 weeks, then every 12 weeks (±1week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
Time From Randomization To First Subsequent Therapy Or Death (TFST)
Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
- +15 more secondary outcomes
Study Arms (2)
1/OLAPARIB
EXPERIMENTALolaparib 300mg oral tablets; twice daily
2/CHEMOTHERAPY
ACTIVE COMPARATORPhysician's choice single agent chemotherapy
Interventions
300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.
Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
Eligibility Criteria
You may qualify if:
- Patients must be ≥ 18 years of age
- Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease \>6 months (\>/=183 days) after completion of their last platinum therapy.
- Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
- At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
- Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
- Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
- Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have a life expectancy ≥ 16 weeks
- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
You may not qualify if:
- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
- Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
- Patients who have platinum resistant or refractory disease
- Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
- Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Myriad Genetic Laboratories, Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (94)
Research Site
Birmingham, Alabama, 35233, United States
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Mobile, Alabama, 36604, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94118, United States
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Aurora, Colorado, 80045, United States
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Littleton, Colorado, 80120, United States
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Hartford, Connecticut, 06106, United States
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Fort Gordon, Georgia, 30905, United States
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Covington, Louisiana, 70433, United States
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Towson, Maryland, 21204, United States
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Detroit, Michigan, 48201, United States
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Albany, New York, 12208, United States
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Mineola, New York, 11501, United States
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Chapel Hill, North Carolina, 27599, United States
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Columbus, Ohio, 43210, United States
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Springfield, Oregon, 97477, United States
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Abington, Pennsylvania, 19001, United States
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Knoxville, Tennessee, 37920, United States
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Nashville, Tennessee, 37232, United States
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Bedford, Texas, 76022, United States
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Houston, Texas, 77030, United States
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Milwaukee, Wisconsin, 53226, United States
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Berazategui, B1884BBF, Argentina
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CABA, C1280AEB, Argentina
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Ciudad de Buenos Aires, C1180AAX, Argentina
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Córdoba, 5000, Argentina
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La Plata, B1897GPD, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Ijuí, 98700-000, Brazil
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Passo Fundo, 99010 260, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90610-000, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-000, Brazil
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X6, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Hradec Králové, 500 05, Czechia
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Ostrava-Poruba, 708 52, Czechia
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Prague, 128 08, Czechia
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Zlín, 762 75, Czechia
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Budapest, 1088, Hungary
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Budapest, 1115, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Miskolc, 3526, Hungary
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Afula, 18101, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 7661041, Israel
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Tel Aviv, 6423906, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Meldola, 47014, Italy
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Messina, 98158, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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México, 07760, Mexico
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México, 6760, Mexico
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Oaxaca City, 68000, Mexico
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Gdansk, 80-219, Poland
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Grzepnica, 72-003, Poland
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Lodz, 93-513, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-561, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 138-736, South Korea
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Seoul, 139-706, South Korea
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08907, Spain
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Córdoba, 14004, Spain
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Girona, 17007, Spain
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Granada, 18014, Spain
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Madrid, 28040, Spain
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Madrid, 28050, Spain
Related Publications (4)
Scambia G, Villalobos Valencia R, Colombo N, Cibula D, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Ah-See ML, Lowe ES, Lukashchuk N, Carter D, Penson RT. Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results. J Clin Oncol. 2025 Apr 20;43(12):1408-1416. doi: 10.1200/JCO.24.00933. Epub 2024 Dec 12.
PMID: 39668137DERIVEDPaulino E, Melo AC. SOLO 3 Trial: How Do the Results Fit in With Current Evidence? J Clin Oncol. 2020 Aug 10;38(23):2697-2698. doi: 10.1200/JCO.20.00576. Epub 2020 Jun 12. No abstract available.
PMID: 32530768DERIVEDPenson RT, Lowe ES. Reply to E. Paulino et al. J Clin Oncol. 2020 Aug 10;38(23):2698. doi: 10.1200/JCO.20.01235. Epub 2020 Jun 12. No abstract available.
PMID: 32530766DERIVEDPenson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.
PMID: 32073956DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- AstraZeneca AB
Study Officials
- PRINCIPAL INVESTIGATOR
Richard T Penson, Associate Prof. of Medicine
Harvard Medical School (HMS and HSDM)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 20, 2014
First Posted
November 4, 2014
Study Start
February 6, 2015
Primary Completion
October 10, 2018
Study Completion
July 19, 2022
Last Updated
July 26, 2022
Results First Posted
December 2, 2019
Record last verified: 2022-07
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 deidentified 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.