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.

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.

Study Overview

• Status: Completed
• Conditions: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
• Intervention / Treatment: Drug: OLAPARIB; Drug: Single agent chemotherapy

Detailed Description

This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. 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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Argentina, B1884BBF
    • Research Site
  • Caba, Argentina, C1280AEB
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1180AAX
    • Research Site
  • Cordoba, Argentina, 5000
    • Research Site
  • La Plata, Argentina, B1897GPD
    • Research Site
  • San Miguel de Tucumán, Argentina, T4000IAK
    • Research Site
• Belgium
  • Gent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
• Brazil
  • Ijui, Brazil, 98700-000
    • Research Site
  • Passo Fundo, Brazil, 99010 260
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Sao Paulo, Brazil, 01246-000
    • Research Site
  • Sao Paulo, Brazil, 01317-000
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X6
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Research Site
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Research Site
  • Ostrava-Poruba, Czechia, 708 52
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
  • Zlin, Czechia, 762 75
    • Research Site
• Hungary
  • Budapest, Hungary, 1115
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1088
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Győr, Hungary, 9024
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
• Israel
  • Afula, Israel, 18101
    • Research Site
  • Haifa, Israel, 31096
    • Research Site
  • Holon, Israel, 58100
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Jerusalem, Israel, 9103102
    • Research Site
  • Petah Tikva, Israel, 4941492
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Rehovot, Israel, 7661041
    • Research Site
  • Tel Hashomer, Israel, 52621
    • Research Site
  • Tel-Aviv, Israel, 6423906
    • Research Site
  • Zerifin, Israel, 70300
    • Research Site
• Italy
  • Meldola, Italy, 47014
    • Research Site
  • Messina, Italy, 98158
    • Research Site
  • Milano, Italy, 20141
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Milano, Italy, 20133
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Roma, Italy, 00168
    • Research Site
  • Roma, Italy, 00144
    • Research Site
• Korea, Republic of
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06273
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
  • Seoul, Korea, Republic of, 138-736
    • Research Site
  • Seoul, Korea, Republic of, 139-706
    • Research Site
• Mexico
  • Mexico, Mexico, 07760
    • Research Site
  • Mexico, Mexico, 6760
    • Research Site
  • Oaxaca, Mexico, 68000
    • Research Site
• Poland
  • Gdańsk, Poland, 80-219
    • Research Site
  • Grzepnica, Poland, 72-003
    • Research Site
  • Lublin, Poland, 20-090
    • Research Site
  • Olsztyn, Poland, 10-561
    • Research Site
  • Poznan, Poland, 60-569
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
  • Łódź, Poland, 93-513
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08907
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • Gerona, Spain, 17007
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28050
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Research Site
    • Mobile, Alabama, United States, 36604
      • Research Site
  • California
    • Sacramento, California, United States, 95817
      • Research Site
    • San Francisco, California, United States, 94118
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Littleton, Colorado, United States, 80120
      • Research Site
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Research Site
  • Georgia
    • Fort Gordon, Georgia, United States, 30905
      • Research Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Research Site
  • Maryland
    • Towson, Maryland, United States, 21204
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • Mineola, New York, United States, 11501
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Research Site
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Research Site
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Research Site
    • Nashville, Tennessee, United States, 37232
      • Research Site
  • Texas
    • Bedford, Texas, United States, 76022
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1/OLAPARIB; olaparib 300mg oral tablets; twice daily	Drug: OLAPARIB; 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.
Active Comparator: 2/CHEMOTHERAPY; Physician's choice single agent chemotherapy	Drug: Single agent chemotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by progression free survival (PFS) using BICR assessment according to RECIST 1.1 criteria PFS is defined as the time from randomization until the date of objective radiological disease progression according to RECIST 1.1 or death (by any cause in the absence of disease progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to disease progression (i.e., date of RECIST progression/death or censoring - date of randomization +1).	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)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by second progression (PFS2). Time from randomization to PFS2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to first progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could involve objective radiological, clinical, cancer antigen-125 (CA-125) progression or death. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG) criteria.	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)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by overall survival (OS). Overall survival is defined as the time from the date of randomisation until death due to any cause.	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	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to earliest progression by RECIST 1.1 or CA-125 or death. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG).	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)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to first subsequent therapy or death (TFST) TFST is defined as the time from the date of randomisation to the earlier of first subsequent chemotherapy start date or death. Anti-cancer treatments include chemotherapy and targeted agents.	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)
Time From Randomization To Second Subsequent Therapy Or Death (TSST)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to second subsequent therapy or death (TSST) TSST was defined as the time from the date of randomisation to the earlier of second subsequent chemotherapy start date or death. Anti-cancer treatments include chemotherapy and targeted agents.	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)
Time From Randomization To Study Treatment Discontinuation Or Death (TDT)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to study treatment discontinuation or death (TDT) TDT was defined as the time from randomization to the earlier of the date of study treatment discontinuation or death.	Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
Duration of Response (DoR)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by duration of response (DoR) by BICR using RECIST 1.1 criteria for evaluable patients. Duration of response is the time from the first documentation of complete response (CR) or partial response (PR) until the date of progression or death, or the last evaluable RECIST assessment for participants that do not progress or progress after 2 missed assessments. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment.	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 to Response (TTR)	To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to response (TTR) by BICR using RECIST 1.1 criteria for evaluable patients. TTR was defined as the time from randomization until the date of first documented response by Blinded independent central review (BICR) assessment.	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)
Mean Change From Baseline In Trial Outcome Index (TOI) Score	To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher HRQoL. A negative change in score from baseline indicated a worsening in symptoms.	Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018
Number of Participants Who Show an Improvement in TOI Score	To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher health-related quality of life (HRQoL). A change in at least 10 points was considered clinically relevant.	Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018
Objective Response Rate (ORR) in Breast Cancer Susceptibility (BRCA) Gene Population by Blinded Independent Central Review (BICR)	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis). The number of participants with complete or partial response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Partial response is declared when there is a decrease in sum of target disease ≥ 30%. Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.	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)
Number of Participants Who Experienced Disease Progression or Death in BRCA Gene Population by Blinded Independent Central Review (BICR)	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis). Progressive disease was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	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)
Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis).	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) in BRCA Gene Population	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis). OS in BRCA gene population was measured by the number of participants who died due to any cause.	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)
Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis).	Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis). Anti-cancer treatments include chemotherapy and targeted agents.	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)
Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population	BRCA gene population includes participants 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 (eg, gene sequencing and large rearrangement analysis). Anti-cancer treatments include chemotherapy and targeted agents.	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)
Geometric Mean Plasma Concentration of Olaparib	Summary of plasma concentrations (ug/mL) of olaparib	Day 1, 1 hour post-dose and Day 29 pre-dose. DCO: 10Oct2018
Number of Participants Who Experience at Least One Adverse Event (AE)	An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.	Safety Follow-up 30 days after last dose of IP, assessed from the date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Merck Sharp & Dohme LLC; Myriad Genetic Laboratories, Inc.
• Investigators: Principal Investigator: Richard T Penson, Associate Prof. of Medicine, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• Paulino 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.
• Penson 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.
• Penson 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.

Helpful Links

• AstraZeneca Cancer Study Locator Service Phone 677 400 4656 Email astrazeneca@emergingmed.com
• Related Info
• Related Info
• CSR Synopsis addendum

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2015
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: BRCA, ovarian, platinum, chemotherapy,
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Olaparib
• Other Study ID Numbers: D0816C00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)