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Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Primary Purpose

Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olaparib 300mg tablets
Placebo to match olaparib 300mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum Sensitive focused on measuring BRCA, Ovarian cancer, Chemotherapy, PARP Inhibitor, Platinum sensitive

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.

    • Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
    • 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 received at least 2 previous lines of platinum containing therapy prior to randomisation

For the penultimate chemotherapy course prior to enrolment on the study:

• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy

For the last chemotherapy course immediately prior to randomisation on the study:

  • Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
  • Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
  • Patients must be randomized within 8 weeks of their last dose of chemotherapy
  • Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • BRCA 1 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 who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.

Sites / Locations

  • University of Alabama at Birmingham
  • Palo Alto Foundation Medical Group
  • University of Colorado
  • The Hospital of Central Connecticut
  • Gynecologic Cancer Center
  • North Shore University
  • Greater Baltimore Medical Center
  • Johns Hopkins
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • MD Anderson at Cooper Cancer Center
  • Womens Cancer Care Associates
  • Winthrop Gynecologic Oncology Associates
  • OSU JamesCare at Mill Run
  • Henry Joyce Cancer Clinic
  • Aurora St Lukes Medical Center
  • Mercy Hospital for Women
  • The Royal Womens Hospital
  • Prince of Wales Hospital
  • U.Z. Gent
  • UZ Leuven Gasthuisberg
  • Centro Diagnóstico Barretos
  • Centro Regional Integrado de Oncologia
  • Hospital Araujo Jorge
  • Hospital de Caridade de Ijuí
  • 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
  • CHUS Site Fleurimont
  • 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.
  • Research Site
  • Shanghai Cancer Hospital of Fudan University
  • The First Affiliated Hospital of Soochow University
  • First affiliated hospital college of XianJiaotong University
  • Institut Bergonie
  • CAC François Baclesse
  • 69LYON, C Bérard, Onco
  • Centre Catherine de Sienne
  • Institut Curie Paris Et Saint Cloud
  • 75PARIS, H Tenon, Onco
  • Hopital Européen Georges Pompidou
  • 69PIERREBE, CH Lyon Sud,
  • 92STCLOUD, C Huguenin, Onco
  • Institut Claudius Regaud
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Helios-Kliniken Berlin - Buch
  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
  • Johann-Wolfgang Goethe-Universität
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Schleswig-Holstein
  • Klinikum rechts der Isar der Technischen Universität
  • Onkologie Ravensburg
  • Universitätsklinikum Rostock
  • Rambam Health Care Campus
  • Sapir Medical Centre
  • Tel Hashomer
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliera Policlinico Di Modena
  • Istituto Nazionale Tumori Fondazione Pascale
  • Istituto Oncologico Veneto Irccs
  • Istituto Regina Elena-Polo Oncologico Ifo
  • Policlinico Universitario A. Gemelli
  • Hyogo Cancer Center
  • National Cancer Center Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Saitama Medical University International Medical Center
  • National Hospital Organization Shikoku Cancer Center
  • Niigata University Medical and Dental Hospital
  • Kindai University Hospital
  • Hokkaido University Hospital
  • Shizuoka Cancer Center
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
  • Maastricht Universitair Medisch Centrum
  • Universitair Medisch Centrum St. Radboud
  • Erasmus 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
  • Chemotherapy Department, Russian Cancer Research Centre
  • St.Petersburg City Oncology Dispensary, Dept. Gynecology
  • Leningrad Regional Oncology Dispensary
  • Barcelona,H.Clinic i Provincial,Oncología
  • Barcelona,H.de la Sta.Creu i S.Pau,Oncología
  • Córdoba,H.Reina Sofía,Oncología
  • Gerona,H.Josep Trueta,Oncología
  • Madrid, H.C.S.Carlos,Oncología
  • Madrid,H.12 de Octubre,Oncología
  • Hospital Provincial de Navarra
  • 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
  • The Christie NHS Foundation Trust
  • Royal Marsden Hospital and Institute of Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olaparib 300mg tablets

Placebo tablets

Arm Description

Taken orally twice daily

Taken orally twice daily

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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.

Secondary Outcome Measures

Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).
Efficacy in Patients Following 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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.
Efficacy in Patients Following 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 relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up 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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Efficacy of Olaparib by 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 randomization to first subsequent therapy or death (TFST).
Efficacy of Olaparib by 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 randomization to second subsequent therapy or death (TSST).
Efficacy of Olaparib by 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 randomization to study treatment discontinuation or death (TDT).
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 future BRCA mutation assays (gene sequencing and large rearrangement analysis).
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

Full Information

First Posted
June 7, 2013
Last Updated
October 19, 2023
Sponsor
AstraZeneca
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01874353
Brief Title
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Official Title
Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 3, 2013 (Actual)
Primary Completion Date
September 19, 2016 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (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)) who have responded following platinum based chemotherapy.
Detailed Description
Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy
Keywords
BRCA, Ovarian cancer, Chemotherapy, PARP Inhibitor, Platinum sensitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olaparib 300mg tablets
Arm Type
Experimental
Arm Description
Taken orally twice daily
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
Taken orally twice daily
Intervention Type
Drug
Intervention Name(s)
Olaparib 300mg tablets
Intervention Description
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo to match olaparib 300mg
Intervention Description
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). 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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Time Frame
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.
Secondary Outcome Measure Information:
Title
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
Description
To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).
Time Frame
Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Title
Efficacy in Patients Following 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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.
Time Frame
CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths.
Title
Efficacy in Patients Following 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 relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression
Time Frame
Scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. Assessments then per local practice every 12 wks until second progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths
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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Time Frame
Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.
Title
Efficacy of Olaparib by 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 randomization to first subsequent therapy or death (TFST).
Time Frame
Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Title
Efficacy of Olaparib by 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 randomization to second subsequent therapy or death (TSST).
Time Frame
Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Title
Efficacy of Olaparib by 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 randomization to study treatment discontinuation or death (TDT).
Time Frame
Time elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
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 future BRCA mutation assays (gene sequencing and large rearrangement analysis).
Time Frame
Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.
Title
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
Description
To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy
Time Frame
Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO.

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: Patients must be ≥ 18 years of age. Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer. 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 received at least 2 previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study: • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study: Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment Patients must be randomized within 8 weeks of their last dose of chemotherapy Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab Exclusion Criteria: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). BRCA 1 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 who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor E Pujade-Lauraine, MD, PhD
Organizational Affiliation
Universite de Paris Descartes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Palo Alto Foundation Medical Group
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Gynecologic Cancer Center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
North Shore University
City
Evanston
State/Province
Illinois
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
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
MD Anderson at Cooper Cancer Center
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Womens Cancer Care Associates
City
Albany
State/Province
New York
Country
United States
Facility Name
Winthrop Gynecologic Oncology Associates
City
Mineola
State/Province
New York
Country
United States
Facility Name
OSU JamesCare at Mill Run
City
Hilliard
State/Province
Ohio
Country
United States
Facility Name
Henry Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Aurora St Lukes Medical Center
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
U.Z. Gent
City
Gent
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Centro Diagnóstico Barretos
City
Barretos
Country
Brazil
Facility Name
Centro Regional Integrado de Oncologia
City
Fortaleza
Country
Brazil
Facility Name
Hospital Araujo Jorge
City
Goiânia
Country
Brazil
Facility Name
Hospital de Caridade de Ijuí
City
Ijuí
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
CHUS Site Fleurimont
City
Sherbrooke
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
Research Site
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Cancer Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
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
Institut Curie Paris Et Saint Cloud
City
Paris Cedex 5
Country
France
Facility Name
75PARIS, H Tenon, Onco
City
Paris
Country
France
Facility Name
Hopital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
69PIERREBE, CH Lyon Sud,
City
Pierre Benite Cedex
Country
France
Facility Name
92STCLOUD, C Huguenin, Onco
City
Saint Cloud
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
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
Helios-Kliniken Berlin - Buch
City
Berlin
Country
Germany
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg
City
Erlangen
Country
Germany
Facility Name
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
City
Essen
Country
Germany
Facility Name
Johann-Wolfgang Goethe-Universität
City
Frankfurt
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität
City
München
Country
Germany
Facility Name
Onkologie Ravensburg
City
Ravensburg
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
Country
Germany
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Sapir Medical Centre
City
Kfar Saba
Country
Israel
Facility Name
Tel Hashomer
City
Ramat Gan
Country
Israel
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico Di Modena
City
Modena
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 Cancer Center
City
Akashi-shi
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-shi
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata-shi
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-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
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance 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
Universitair Medisch Centrum St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
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
Chemotherapy Department, Russian Cancer Research Centre
City
Moscow
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
Barcelona,H.Clinic i Provincial,Oncología
City
Barcelona
Country
Spain
Facility Name
Barcelona,H.de la Sta.Creu i S.Pau,Oncología
City
Barcelona
Country
Spain
Facility Name
Córdoba,H.Reina Sofía,Oncología
City
Córdoba
Country
Spain
Facility Name
Gerona,H.Josep Trueta,Oncología
City
Gerona
Country
Spain
Facility Name
Madrid, H.C.S.Carlos,Oncología
City
Madrid
Country
Spain
Facility Name
Madrid,H.12 de Octubre,Oncología
City
Madrid
Country
Spain
Facility Name
Hospital Provincial de Navarra
City
Pamplona
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
The Christie NHS Foundation Trust
City
Manchester
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
35772665
Citation
Frenel JS, Kim JW, Aryal N, Asher R, Berton D, Vidal L, Pautier P, Ledermann JA, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Colombo N, Park-Simon TW, Tamura K, Sonke GS, Freimund AE, Lee CK, Pujade-Lauraine E. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol. 2022 Oct;33(10):1021-1028. doi: 10.1016/j.annonc.2022.06.011. Epub 2022 Jun 27.
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
33743851
Citation
Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18.
Results Reference
derived
PubMed Identifier
32977221
Citation
Tjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23.
Results Reference
derived
PubMed Identifier
30026002
Citation
Friedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17.
Results Reference
derived
PubMed Identifier
28754483
Citation
Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0816C00002&attachmentIdentifier=b78b290c-58f4-42f8-902e-c6641f7cf141&fileName=d0816c00002.pdf&versionIdentifier=
Description
Redacted CSR synopsis

Learn more about this trial

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

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