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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)

Primary Purpose

Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

OLAPARIB

Single agent chemotherapy

About this trial

This is an interventional treatment trial for Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity focused on measuring BRCA, ovarian, platinum, chemotherapy,

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1/OLAPARIB

2/CHEMOTHERAPY

Arm Description

olaparib 300mg oral tablets; twice daily

Physician's choice single agent chemotherapy

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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).

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population

Overall Survival (OS) in BRCA Gene Population

Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population

Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population

Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population

Geometric Mean Plasma Concentration of Olaparib

Summary of plasma concentrations (ug/mL) of olaparib

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.

Full Information

NCT ID

NCT02282020

First Posted

October 20, 2014

Last Updated

July 25, 2022

Sponsor

AstraZeneca

Collaborators

Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02282020

Brief Title

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

Acronym

SOLO3

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 6, 2015 (Actual)

Primary Completion Date

October 10, 2018 (Actual)

Study Completion Date

July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Keywords

BRCA, ovarian, platinum, chemotherapy,

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1/OLAPARIB

Arm Type

Experimental

Arm Description

olaparib 300mg oral tablets; twice daily

Arm Title

2/CHEMOTHERAPY

Arm Type

Active Comparator

Arm Description

Physician's choice single agent chemotherapy

Intervention Type

Drug

Intervention Name(s)

OLAPARIB

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Single agent chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

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 Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Title

Time From Randomisation to Second Progression (PFS2)

Description

Time Frame

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)

Title

Overall Survival (OS)

Description

Time Frame

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)

Title

Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or Death

Description

Time Frame

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)

Title

Time From Randomization To First Subsequent Therapy Or Death (TFST)

Description

Time Frame

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)

Title

Time From Randomization To Second Subsequent Therapy Or Death (TSST)

Description

Time Frame

Title

Time From Randomization To Study Treatment Discontinuation Or Death (TDT)

Description

Time Frame

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)

Title

Duration of Response (DoR)

Description

Time Frame

Title

Time to Response (TTR)

Description

Time Frame

Title

Mean Change From Baseline In Trial Outcome Index (TOI) Score

Description

Time Frame

Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018

Title

Number of Participants Who Show an Improvement in TOI Score

Description

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.

Time Frame

Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018

Title

Objective Response Rate (ORR) in Breast Cancer Susceptibility (BRCA) Gene Population by Blinded Independent Central Review (BICR)

Description

Time Frame

Title

Number of Participants Who Experienced Disease Progression or Death in BRCA Gene Population by Blinded Independent Central Review (BICR)

Description

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.

Time Frame

Title

Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population

Description

Time Frame

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)

Title

Overall Survival (OS) in BRCA Gene Population

Description

Time Frame

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)

Title

Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population

Description

Time Frame

Title

Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population

Description

Time Frame

Title

Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population

Description

Time Frame

Title

Geometric Mean Plasma Concentration of Olaparib

Description

Summary of plasma concentrations (ug/mL) of olaparib

Time Frame

Day 1, 1 hour post-dose and Day 29 pre-dose. DCO: 10Oct2018

Title

Number of Participants Who Experience at Least One Adverse Event (AE)

Description

Time Frame

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard T Penson, Associate Prof. of Medicine

Organizational Affiliation

Harvard Medical School (HMS and HSDM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Research Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Facility Name

Research Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Research Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Research Site

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Research Site

City

Fort Gordon

State/Province

Georgia

ZIP/Postal Code

30905

Country

United States

Facility Name

Research Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Research Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Research Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Research Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Research Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Research Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Research Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

Berazategui

ZIP/Postal Code

B1884BBF

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Research Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

C1180AAX

Country

Argentina

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Research Site

City

La Plata

ZIP/Postal Code

B1897GPD

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucumán

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Ijui

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Research Site

City

Passo Fundo

ZIP/Postal Code

99010 260

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

22793-080

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01317-000

Country

Brazil

Facility Name

Research Site

City

São José do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X6

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Zlin

ZIP/Postal Code

762 75

Country

Czechia

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Research Site

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Research Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Research Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Rehovot

ZIP/Postal Code

7661041

Country

Israel

Facility Name

Research Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Research Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Research Site

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Facility Name

Research Site

City

Messina

ZIP/Postal Code

98158

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

139-706

Country

Korea, Republic of

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

6760

Country

Mexico

Facility Name

Research Site

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Research Site

City

Grzepnica

ZIP/Postal Code

72-003

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-561

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Research Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

32530768

Citation

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. No abstract available.

Results Reference

derived

PubMed Identifier

32530766

Citation

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. No abstract available.

Results Reference

derived

PubMed Identifier

32073956

Citation

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.

Results Reference

derived

Links:

URL

http://emergingmed.com/networks/AstraZeneca

Description

AstraZeneca Cancer Study Locator Service Phone 677 400 4656 Email astrazeneca@emergingmed.com

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=041c3c95-2c81-475b-ae11-1769903a7112&fileName=20190614_SOLO-3_d0816c00010_Protocol_Amendment-v4_20Dec17_Final_Redacted_(1).pdf&versionIdentifier=

Description

Related Info

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=4ef96d32-3bc9-474b-8bcf-0c6fd80190aa&fileName=20190614_AZ_SOLO-3_Statistical_Analysis_Plan_v4_30-Oct-2018_Final_Redacted_(1).pdf&versionIdentifier=

Description

Related Info

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00010&attachmentIdentifier=0e755241-5571-4243-b9f4-92b1001d85b3&fileName=d0816c00010-add2-CSRsynopsis-redacted.pdf&versionIdentifier=

Description

CSR Synopsis addendum

Learn more about this trial

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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)

Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial