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Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1)

Primary Purpose

Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Olaparib 300mg tablets

About this trial

This is an interventional treatment trial for Newly Diagnosed focused on measuring BRCA, Ovarian Cancer, Chemotherapy, PARP inhibitor, First Line, FIGO Stage III, FIGO Stage IV

Eligibility Criteria

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

Inclusion Criteria:

Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
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 completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

BRCA1 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 with early stage disease (FIGO Stage I, IIA, IIB or IIC)
Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olaparib tablets p.o. 300mg twice daily

Placebo tablets p.o. twice daily

Arm Description

Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Outcomes

Primary Outcome Measures

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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

Secondary Outcome Measures

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

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 overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.

Efficacy in Patients Following First Line 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 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 to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of 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 randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

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 potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)

Full Information

NCT ID

NCT01844986

First Posted

April 30, 2013

Last Updated

September 6, 2023

Sponsor

AstraZeneca

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01844986

Brief Title

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Acronym

SOLO-1

Official Title

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 26, 2013 (Actual)

Primary Completion Date

May 17, 2018 (Actual)

Study Completion Date

August 29, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Detailed Description

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy

6. Conditions and Keywords

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

Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation, Complete Response, Partial Response, First Line Platinum Chemotherapy

Keywords

BRCA, Ovarian Cancer, Chemotherapy, PARP inhibitor, First Line, FIGO Stage III, FIGO Stage IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olaparib tablets p.o. 300mg twice daily

Arm Type

Experimental

Arm Description

Arm Title

Placebo tablets p.o. twice daily

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Olaparib 300mg tablets

Intervention Description

Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Description

Time Frame

Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

Secondary Outcome Measure Information:

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

Description

Time Frame

Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death

Description

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 to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death

Time Frame

CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

Description

Time Frame

Following first progression disease then assessed per local practice every 12 weeks until second progression.

Title

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)

Description

Time Frame

Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

Description

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 randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time Frame

Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)

Description

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 randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time Frame

Title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)

Description

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 randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time Frame

Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Title

Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS

Description

Time Frame

Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 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: Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal). Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery. 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 completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study. Patients must be randomized within 8 weeks of their last dose of chemotherapy Exclusion Criteria: BRCA1 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 with early stage disease (FIGO Stage I, IIA, IIB or IIC) Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment. Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible). Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer. Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease). Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof Paul DiSilvestro, MD

Organizational Affiliation

Women & Infants Hospital, Providence, Rhode Island, USA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Prof Kathleen Moore, MD

Organizational Affiliation

University of Oklahoma Health Sciences Center, Oklahoma City, USA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clearview Cancer Institute

City

Huntsville

State/Province

Alabama

Country

United States

Facility Name

Providence Cancer Center

City

Anchorage

State/Province

Alaska

Country

United States

Facility Name

St. Joseph's Hospital & Medical Center

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

Country

United States

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Kaiser Permanente

City

Oakland

State/Province

California

Country

United States

Facility Name

Kaiser Permanente

City

Roseville

State/Province

California

Country

United States

Facility Name

Stanford Women's Cancer Center

City

Stanford

State/Province

California

Country

United States

Facility Name

Babak Edraki

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

Country

United States

Facility Name

Univ of Connecticut Health Center

City

Farmington

State/Province

Connecticut

Country

United States

Facility Name

Smilow Cancer Hospital at Yale New Haven

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

Florida Hospital Cancer Institute

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Gynecologic Cancer Center

City

Orlando

State/Province

Florida

Country

United States

Facility Name

H Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Northside Hospital

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Northeast Georgia Medical Center

City

Gainesville

State/Province

Georgia

Country

United States

Facility Name

Nancy N. & J.C. Lewis Cancer and Research Pavillion

City

Savannah

State/Province

Georgia

Country

United States

Facility Name

The Queen's Medical Center

City

Honolulu

State/Province

Hawaii

Country

United States

Facility Name

University of Hawaii

City

Honolulu

State/Province

Hawaii

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Univ Chicago Medical Center

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Advocate Lutheran General Hospital

City

Park Ridge

State/Province

Illinois

Country

United States

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

St. Vincent Hospital & Health Care Center

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Northern Indiana Cancer Research Consortium

City

Mishawaka

State/Province

Indiana

Country

United States

Facility Name

McFarland Clinic, P.C.

City

Ames

State/Province

Iowa

Country

United States

Facility Name

Norton Cancer Institute Research

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

Maine Medical Partners

City

Scarborough

State/Province

Maine

Country

United States

Facility Name

Greater Baltimore Medical Center

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Johns Hopkins

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

Country

United States

Facility Name

Gynecologic Oncology of West MI, PLLC

City

Grand Rapids

State/Province

Michigan

Country

United States

Facility Name

Minnesota Oncology Hematology, PA

City

Edina

State/Province

Minnesota

Country

United States

Facility Name

Mayo Clinic - Rochester, MN

City

Rochester

State/Province

Minnesota

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Missouri Valley Cancer Consortium CCOP

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Nebraska Methodist Hospital

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Womens Cancer Center of Nevada

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

MD Anderson at Cooper Cancer Center

City

Camden

State/Province

New Jersey

Country

United States

Facility Name

John Theurer Cancer Center

City

Hackensack

State/Province

New Jersey

Country

United States

Facility Name

University of New Mexico

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Women's Cancer Care Associates

City

Albany

State/Province

New York

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

Country

United States

Facility Name

Mount Sinai Medical Center - New York

City

New York

State/Province

New York

Country

United States

Facility Name

Perlmutter Cancer Center

City

New York

State/Province

New York

Country

United States

Facility Name

Hope Women's Cancer Centers

City

Asheville

State/Province

North Carolina

Country

United States

Facility Name

UNC Chapel Hill

City

Chapel Hill

State/Province

North Carolina

Country

United States

Facility Name

Levine Cancer Institute

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

Country

United States

Facility Name

Sanford Roger Maris Cancer Center

City

Fargo

State/Province

North Dakota

Country

United States

Facility Name

Aultman Hospital

City

Canton

State/Province

Ohio

Country

United States

Facility Name

Cleveland Clinic Cancer Center at Fairview Hospital

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

University Hospital Case Medical Center

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Kettering Medical Center

City

Kettering

State/Province

Ohio

Country

United States

Facility Name

Hillcrest Hospital Cancer Center

City

Mayfield Heights

State/Province

Ohio

Country

United States

Facility Name

Peggy and Charles Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Abington Memorial Hospital

City

Abington

State/Province

Pennsylvania

Country

United States

Facility Name

St. Luke's University Health Network

City

Bethlehem

State/Province

Pennsylvania

Country

United States

Facility Name

The University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Women and Infants Hospital

City

Providence

State/Province

Rhode Island

Country

United States

Facility Name

South Carolina Oncology Associates, PA

City

Columbia

State/Province

South Carolina

Country

United States

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

Country

United States

Facility Name

Sanford Clinic Women's Health

City

Sioux Falls

State/Province

South Dakota

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

Country

United States

Facility Name

University of Texas Health Science Center of Houston

City

Houston

State/Province

Texas

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

Country

United States

Facility Name

Virginia Oncology Associates

City

Norfolk

State/Province

Virginia

Country

United States

Facility Name

Carilion Clinic Gynecological Oncology

City

Roanoke

State/Province

Virginia

Country

United States

Facility Name

Aurora Baycare Medical Center

City

Green Bay

State/Province

Wisconsin

Country

United States

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

Country

United States

Facility Name

Froedtert Memorial Hospital

City

Milwaukee

State/Province

Wisconsin

Country

United States

Facility Name

Mercy Hospital for Women

City

Heidelberg

Country

Australia

Facility Name

The Royal Womens Hospital

City

Parkville

Country

Australia

Facility Name

Prince of Wales Hospital

City

Randwick

Country

Australia

Facility Name

Centro Diagnóstico Barretos

City

Barretos

Country

Brazil

Facility Name

Hospital Araujo Jorge

City

Goiânia

Country

Brazil

Facility Name

Centro de Novos Tratamentos Itajai

City

Itajai

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

Country

Brazil

Facility Name

Irmandade da Santa Casa de Misericordia de Porto Alagre

City

Porto Alegre

Country

Brazil

Facility Name

Hospital de Base São José do Rio Preto

City

São José do Rio Preto

Country

Brazil

Facility Name

Centro de Referencia da Saude da Mulher

City

São Paulo

Country

Brazil

Facility Name

Instituto do Câncer de São Paulo

City

São Paulo

Country

Brazil

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Sunnybrook Health Sciences Center

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

CHUM - Hopital Norte-Dame

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Royal Victoria Hospital

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Hotel-Dieu de Quebec

City

Quebec

Country

Canada

Facility Name

Beijing Cancer Hospital

City

Beijing

Country

China

Facility Name

The Tumor Hospital affiliated to China Medical Science Insti

City

Beijing

Country

China

Facility Name

1st Hospital of Jilin university

City

Changchun

Country

China

Facility Name

Jilin Provincial Cancer Hospital

City

Changchun

Country

China

Facility Name

Hunan Cancer Hospital

City

Changsha

Country

China

Facility Name

West China Hospital Affiliated to Sichuan University

City

Chengdu

Country

China

Facility Name

ChongQing Cancer Hospital

City

Chongqing

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

Women's Hospital, Zhejaing University School of Medicine

City

Hangzhou

Country

China

Facility Name

The Tumour Hospital of Harbin Medical University

City

Harbin

Country

China

Facility Name

Zhejiang Cancer Hospital, Huangzhou

City

Huangzhou

Country

China

Facility Name

JINAN, Qi Lu Hosp. of SD Univ.

City

Ji Nan

Country

China

Facility Name

Obstetris and Gynecology Hospital of Fudan University

City

Shanghai

Country

China

Facility Name

Shanghai Cancer Hospital of Fudan University

City

Shanghai

Country

China

Facility Name

The First Affiliated Hospital of Soochow Universit

City

Suzhou

Country

China

Facility Name

First affiliated hospital college of XianJiaotong University

City

Xian

Country

China

Facility Name

Institut Bergonie

City

Bordeaux

Country

France

Facility Name

CAC François Baclesse

City

Caen Cedex

Country

France

Facility Name

69LYON, C Bérard, Onco

City

Lyon Cedex 08

Country

France

Facility Name

Centre Catherine de Sienne

City

Nantes,

Country

France

Facility Name

75PARIS, H Tenon, Onco

City

Paris

Country

France

Facility Name

Centre Alexis Vautrin

City

Vandoeuvre Les Nancy

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif Cedex

Country

France

Facility Name

Rambam Health Care Campus

City

Haifa

Country

Israel

Facility Name

Sapir Medical Centre

City

Kfar Saba

Country

Israel

Facility Name

Rabin MC

City

Petach Tikva

Country

Israel

Facility Name

Chaim Sheba Medical Centre

City

Tel Hashomer

Country

Israel

Facility Name

Tel-Aviv Sourkasy Medical Center

City

Tel-Aviv

Country

Israel

Facility Name

Bari- Istituto Tumori Giovanni Paolo II

City

Bari

Country

Italy

Facility Name

Azienda Ospedaliera "Cannizzaro"

City

Catania

Country

Italy

Facility Name

Istituto Europeo di Oncologia

City

Milano

Country

Italy

Facility Name

Istituto Nazionale Per Cura Tumori - Milano

City

Milano

Country

Italy

Facility Name

Istituto Nazionale Tumori Fondazione Pascale

City

Napoli

Country

Italy

Facility Name

Istituto Oncologico Veneto Irccs

City

Padova

Country

Italy

Facility Name

Istituto Regina Elena-Polo Oncologico Ifo

City

Roma

Country

Italy

Facility Name

Policlinico Universitario A. Gemelli

City

Roma

Country

Italy

Facility Name

Hyogo CC

City

Akashi-shi

Country

Japan

Facility Name

National Cancer Center Hosp

City

Chuo-ku

Country

Japan

Facility Name

NHO Kyushu CC

City

Fukuoka

Country

Japan

Facility Name

Saitama Med. Univ. Int. Med. C

City

Hidaka-shi

Country

Japan

Facility Name

NHO Shikoku Cancer Center

City

Matsuyama-shi

Country

Japan

Facility Name

Niigata Univ. Med. Dent.

City

Niigata-shi

Country

Japan

Facility Name

Hokkaido University Hospital

City

Sapporo-shi

Country

Japan

Facility Name

Shizuoka Cancer Center

City

Sunto-gun

Country

Japan

Facility Name

National Cancer Center

City

Goyang-si

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Korea Cancer Center Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

City

Amsterdam

Country

Netherlands

Facility Name

Maastricht Universitair Medisch Centrum

City

Maastricht

Country

Netherlands

Facility Name

Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

City

Grzepnica

Country

Poland

Facility Name

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

City

Olsztyn

Country

Poland

Facility Name

Wojewódzki Szpital Specjalistyczny w Olsztynie

City

Olsztyn

Country

Poland

Facility Name

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

City

Warszawa

Country

Poland

Facility Name

Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

City

Warszawa

Country

Poland

Facility Name

Udmurtia Republic Clinical Oncology Center

City

Izhevsk

Country

Russian Federation

Facility Name

Chemotherapy Department, Russian Cancer Research Centre

City

Moscow

Country

Russian Federation

Facility Name

State Institution of Heath Omsk Regional Oncology Dispensary

City

Omsk

Country

Russian Federation

Facility Name

Cancer Research Institute

City

Saint Petersburg

Country

Russian Federation

Facility Name

St.Petersburg City Oncology Dispensary, Dept. Gynecology

City

Saint Petersburg

Country

Russian Federation

Facility Name

Leningrad Regional Oncology Dispensary

City

St.Petersburg

Country

Russian Federation

Facility Name

Research Institute of Oncology RAMS

City

Tomsk

Country

Russian Federation

Facility Name

Barcelona,H.Vall d´Hebrón,Oncología

City

Barcelona

Country

Spain

Facility Name

Córdoba,H.Reina Sofía,Oncología

City

Córdoba

Country

Spain

Facility Name

H.Llobregat,ICO-Duran i Reynals,Oncología

City

Hospitalet deLlobregat(Barcelo

Country

Spain

Facility Name

Madrid, MD Anderson, Oncología

City

Madrid

Country

Spain

Facility Name

Madrid,H.U.La Paz,Oncología

City

Madrid

Country

Spain

Facility Name

Valencia, IVO, Oncología

City

Valencia

Country

Spain

Facility Name

Valencia,H.C.U.Valencia,Oncología

City

Valencia

Country

Spain

Facility Name

City Hospital, Birmingham, Cancer Trials Team

City

Birmingham

Country

United Kingdom

Facility Name

Addenbrooke's Hospital

City

Cambridge

Country

United Kingdom

Facility Name

Arden Cancer Centre

City

Coventry

Country

United Kingdom

Facility Name

Edinburgh Cancer Research UK Centre

City

Edinburgh

Country

United Kingdom

Facility Name

Cancer Research UK and UCL Cancer Trials Centre

City

London

Country

United Kingdom

Facility Name

Royal Marsden Hospital

City

London

Country

United Kingdom

Facility Name

Royal Marsden Hospital and Institute of Cancer Research

City

Sutton

Country

United Kingdom

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.

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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

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

Citations:

PubMed Identifier

36082969

Citation

DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549. Epub 2022 Sep 9.

Results Reference

derived

PubMed Identifier

35170751

Citation

Tattersall 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.

Results Reference

derived

PubMed Identifier

34715071

Citation

Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26. Erratum In: Lancet Oncol. 2021 Dec;22(12):e539.

Results Reference

derived

PubMed Identifier

33862001

Citation

Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.

Results Reference

derived

PubMed Identifier

30345884

Citation

Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Clinical%20Study%20Protocol.pdf

Description

Redacted Clinical Study Protocol

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Statistical%20Analysis%20Plan.pdf

Description

Redacted Statistical Analysis Plan

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1817&filename=SOLO1_Statistiacal%20Analysis%20Plan..pdf

Description

Redacted Statistical Analysis Plan

Learn more about this trial

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

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Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1)

Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV

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