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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
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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.

Sites / Locations

  • Clearview Cancer Institute
  • Providence Cancer Center
  • St. Joseph's Hospital & Medical Center
  • Cedars-Sinai Medical Center
  • University of California, Los Angeles
  • Kaiser Permanente
  • Kaiser Permanente
  • Stanford Women's Cancer Center
  • Babak Edraki
  • University of Colorado
  • Univ of Connecticut Health Center
  • Smilow Cancer Hospital at Yale New Haven
  • Florida Hospital Cancer Institute
  • Gynecologic Cancer Center
  • H Lee Moffitt Cancer Center and Research Institute
  • Northside Hospital
  • Northeast Georgia Medical Center
  • Nancy N. & J.C. Lewis Cancer and Research Pavillion
  • The Queen's Medical Center
  • University of Hawaii
  • Northwestern University
  • Univ Chicago Medical Center
  • Advocate Lutheran General Hospital
  • Indiana University
  • St. Vincent Hospital & Health Care Center
  • Northern Indiana Cancer Research Consortium
  • McFarland Clinic, P.C.
  • Norton Cancer Institute Research
  • Maine Medical Partners
  • Greater Baltimore Medical Center
  • Johns Hopkins
  • Walter Reed National Military Medical Center
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • Henry Ford Health System
  • Gynecologic Oncology of West MI, PLLC
  • Minnesota Oncology Hematology, PA
  • Mayo Clinic - Rochester, MN
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Missouri Valley Cancer Consortium CCOP
  • Nebraska Methodist Hospital
  • Womens Cancer Center of Nevada
  • MD Anderson at Cooper Cancer Center
  • John Theurer Cancer Center
  • University of New Mexico
  • Women's Cancer Care Associates
  • Roswell Park Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Mount Sinai Medical Center - New York
  • Perlmutter Cancer Center
  • Hope Women's Cancer Centers
  • UNC Chapel Hill
  • Levine Cancer Institute
  • Duke University Medical Center
  • Sanford Roger Maris Cancer Center
  • Aultman Hospital
  • Cleveland Clinic Cancer Center at Fairview Hospital
  • Cleveland Clinic Foundation
  • University Hospital Case Medical Center
  • Research Site
  • Kettering Medical Center
  • Hillcrest Hospital Cancer Center
  • Peggy and Charles Stephenson Cancer Center
  • Abington Memorial Hospital
  • St. Luke's University Health Network
  • The University of Pennsylvania
  • Women and Infants Hospital
  • South Carolina Oncology Associates, PA
  • Avera Cancer Institute
  • Sanford Clinic Women's Health
  • University of Texas Southwestern Medical Center
  • MD Anderson Cancer Center
  • University of Texas Health Science Center of Houston
  • University of Virginia
  • Virginia Oncology Associates
  • Carilion Clinic Gynecological Oncology
  • Aurora Baycare Medical Center
  • University of Wisconsin-Madison
  • Froedtert Memorial Hospital
  • Mercy Hospital for Women
  • The Royal Womens Hospital
  • Prince of Wales Hospital
  • Centro Diagnóstico Barretos
  • Hospital Araujo Jorge
  • Centro de Novos Tratamentos Itajai
  • Hospital de Clinicas de Porto Alegre
  • Irmandade da Santa Casa de Misericordia de Porto Alagre
  • Hospital de Base São José do Rio Preto
  • Centro de Referencia da Saude da Mulher
  • Instituto do Câncer de São Paulo
  • Juravinski Cancer Centre
  • London Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Sunnybrook Health Sciences Center
  • CHUM - Hopital Norte-Dame
  • Royal Victoria Hospital
  • Hotel-Dieu de Quebec
  • Beijing Cancer Hospital
  • The Tumor Hospital affiliated to China Medical Science Insti
  • 1st Hospital of Jilin university
  • Jilin Provincial Cancer Hospital
  • Hunan Cancer Hospital
  • West China Hospital Affiliated to Sichuan University
  • ChongQing Cancer Hospital
  • Research Site
  • Women's Hospital, Zhejaing University School of Medicine
  • The Tumour Hospital of Harbin Medical University
  • Zhejiang Cancer Hospital, Huangzhou
  • JINAN, Qi Lu Hosp. of SD Univ.
  • Obstetris and Gynecology Hospital of Fudan University
  • Shanghai Cancer Hospital of Fudan University
  • The First Affiliated Hospital of Soochow Universit
  • First affiliated hospital college of XianJiaotong University
  • Institut Bergonie
  • CAC François Baclesse
  • 69LYON, C Bérard, Onco
  • Centre Catherine de Sienne
  • 75PARIS, H Tenon, Onco
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Rambam Health Care Campus
  • Sapir Medical Centre
  • Rabin MC
  • Chaim Sheba Medical Centre
  • Tel-Aviv Sourkasy Medical Center
  • Bari- Istituto Tumori Giovanni Paolo II
  • Azienda Ospedaliera "Cannizzaro"
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Per Cura Tumori - Milano
  • Istituto Nazionale Tumori Fondazione Pascale
  • Istituto Oncologico Veneto Irccs
  • Istituto Regina Elena-Polo Oncologico Ifo
  • Policlinico Universitario A. Gemelli
  • Hyogo CC
  • National Cancer Center Hosp
  • NHO Kyushu CC
  • Saitama Med. Univ. Int. Med. C
  • NHO Shikoku Cancer Center
  • Niigata Univ. Med. Dent.
  • Hokkaido University Hospital
  • Shizuoka Cancer Center
  • National Cancer Center
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Korea Cancer Center Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
  • Maastricht Universitair Medisch Centrum
  • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
  • Wojewódzki Szpital Specjalistyczny w Olsztynie
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
  • Udmurtia Republic Clinical Oncology Center
  • Chemotherapy Department, Russian Cancer Research Centre
  • State Institution of Heath Omsk Regional Oncology Dispensary
  • Cancer Research Institute
  • St.Petersburg City Oncology Dispensary, Dept. Gynecology
  • Leningrad Regional Oncology Dispensary
  • Research Institute of Oncology RAMS
  • Barcelona,H.Vall d´Hebrón,Oncología
  • Córdoba,H.Reina Sofía,Oncología
  • H.Llobregat,ICO-Duran i Reynals,Oncología
  • Madrid, MD Anderson, Oncología
  • Madrid,H.U.La Paz,Oncología
  • Valencia, IVO, Oncología
  • Valencia,H.C.U.Valencia,Oncología
  • City Hospital, Birmingham, Cancer Trials Team
  • Addenbrooke's Hospital
  • Arden Cancer Centre
  • Edinburgh Cancer Research UK Centre
  • Cancer Research UK and UCL Cancer Trials Centre
  • Royal Marsden Hospital
  • Royal Marsden Hospital and Institute of Cancer Research

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

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
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 progression (PFS2)
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

First Posted
April 30, 2013
Last Updated
September 6, 2023
Sponsor
AstraZeneca
Collaborators
GOG Foundation, Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
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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
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
Arm Title
Placebo tablets p.o. twice daily
Arm Type
Placebo Comparator
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
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
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.
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
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.
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
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 progression (PFS2)
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
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.
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
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 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
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)
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
No
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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