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

January 15, 2024 updated by: AstraZeneca

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Heidelberg, Australia
        • Mercy Hospital for Women
      • Parkville, Australia
        • The Royal Womens Hospital
      • Randwick, Australia
        • Prince of Wales Hospital
      • Gent, Belgium
        • U.Z. Gent
      • Leuven, Belgium
        • UZ Leuven Gasthuisberg
      • Barretos, Brazil
        • Centro Diagnóstico Barretos
      • Fortaleza, Brazil
        • Centro Regional Integrado de Oncologia
      • Goiânia, Brazil
        • Hospital Araujo Jorge
      • Ijuí, Brazil
        • Hospital de Caridade de Ijui
      • Itajai, Brazil
        • Centro De Novos Tratamentos Itajai
      • Porto Alegre, Brazil
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Brazil
        • Irmandade da Santa Casa de Misericordia de Porto Alagre
      • São José do Rio Preto, Brazil
        • Hospital de Base São José do Rio Preto
      • São Paulo, Brazil
        • Centro de Referencia da Saude da Mulher
      • São Paulo, Brazil
        • Instituto do Câncer de São Paulo
      • Quebec, Canada
        • Hotel-Dieu de Quebec
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada
        • CHUM - Hopital Norte-Dame
      • Sherbrooke, Quebec, Canada
        • CHUS Site Fleurimont
      • Beijing, China
        • Beijing Cancer Hospital
      • Beijing, China
        • The Tumor Hospital affiliated to China Medical Science Insti
      • Changchun, China
        • 1st Hospital of Jilin university
      • Changchun, China
        • Jilin Provincial Cancer Hospital
      • Changsha, China
        • Hunan Cancer Hospital
      • Chengdu, China
        • West China Hospital Affiliated to Sichuan University
      • Chongqing, China
        • Chongqing Cancer Hospital
      • Guangzhou, China, 510060
        • Research Site
      • Hangzhou, China
        • Women's Hospital, Zhejaing University School of Medicine
      • Harbin, China
        • The Tumour Hospital of Harbin Medical University
      • Huangzhou, China
        • Zhejiang Cancer Hospital, Huangzhou
      • Ji Nan, China
        • JINAN, Qi Lu Hosp. of SD Univ.
      • Shanghai, China, 200011
        • Research Site
      • Shanghai, China
        • Shanghai Cancer Hospital of Fudan University
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Xian, China
        • First affiliated hospital college of XianJiaotong University
      • Bordeaux, France
        • Institut Bergonie
      • Caen Cedex, France
        • CAC François Baclesse
      • Lyon Cedex 08, France
        • 69LYON, C Bérard, Onco
      • Nantes,, France
        • Centre Catherine De Sienne
      • Paris, France
        • Hopital Europeen Georges Pompidou
      • Paris, France
        • 75PARIS, H Tenon, Onco
      • Paris Cedex 5, France
        • Institut Curie Paris Et Saint Cloud
      • Pierre Benite Cedex, France
        • 69PIERREBE, CH Lyon Sud,
      • Saint Cloud, France
        • 92STCLOUD, C Huguenin, Onco
      • Toulouse, France
        • Institut Claudius Regaud
      • Vandoeuvre Les Nancy, France
        • Centre Alexis Vautrin
      • Villejuif Cedex, France
        • Institut Gustave Roussy
      • Berlin, Germany
        • Helios-Kliniken Berlin - Buch
      • Erlangen, Germany
        • Friedrich-Alexander-Universität Erlangen-Nürnberg
      • Essen, Germany
        • Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH
      • Frankfurt, Germany
        • Johann-Wolfgang Goethe-Universität
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein
      • München, Germany
        • Klinikum rechts der Isar der Technischen Universität
      • Ravensburg, Germany
        • Onkologie Ravensburg
      • Rostock, Germany
        • Universitätsklinikum Rostock
      • Haifa, Israel
        • Rambam Health Care Campus
      • Kfar Saba, Israel
        • Sapir Medical Centre
      • Ramat Gan, Israel
        • Tel hashomer
      • Milano, Italy
        • Istituto Europeo di Oncologia
      • Modena, Italy
        • Azienda Ospedaliera Policlinico di Modena
      • Napoli, Italy
        • Istituto Nazionale Tumori Fondazione Pascale
      • Padova, Italy
        • Istituto Oncologico Veneto IRCCS
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Roma, Italy
        • Istituto Regina Elena-Polo Oncologico Ifo
      • Akashi-shi, Japan
        • Hyogo Cancer Center
      • Chuo-ku, Japan
        • National Cancer Center Hospital
      • Fukuoka, Japan
        • National Hospital Organization Kyushu Cancer Center
      • Hidaka-shi, Japan
        • Saitama Medical University International Medical Center
      • Matsuyama-shi, Japan
        • National Hospital Organization Shikoku Cancer Center
      • Niigata-shi, Japan
        • Niigata University Medical and Dental Hospital
      • Osakasayama-shi, Japan
        • Kindai University Hospital
      • Sapporo-shi, Japan
        • Hokkaido University Hospital
      • Sunto-gun, Japan
        • Shizuoka Cancer Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Amsterdam, Netherlands
        • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
      • Maastricht, Netherlands
        • Maastricht Universitair Medisch Centrum
      • Nijmegen, Netherlands
        • Universitair Medisch Centrum St. Radboud
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
      • Grzepnica, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
      • Olsztyn, Poland
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
      • Olsztyn, Poland
        • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
      • Warszawa, Poland
        • Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
      • Warszawa, Poland
        • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
      • Moscow, Russian Federation
        • Chemotherapy Department, Russian Cancer Research Centre
      • Saint Petersburg, Russian Federation
        • St.Petersburg City Oncology Dispensary, Dept. Gynecology
      • St.Petersburg, Russian Federation
        • Leningrad Regional Oncology Dispensary
      • Barcelona, Spain
        • Barcelona,H.Clinic i Provincial,Oncología
      • Barcelona, Spain
        • Barcelona,H.de la Sta.Creu i S.Pau,Oncología
      • Córdoba, Spain
        • Córdoba,H.Reina Sofía,Oncología
      • Gerona, Spain
        • Gerona,H.Josep Trueta,Oncología
      • Madrid, Spain
        • Madrid, H.C.S.Carlos,Oncología
      • Madrid, Spain
        • Madrid,H.12 de Octubre,Oncología
      • Pamplona, Spain
        • Hospital Provincial de Navarra
      • Valencia, Spain
        • Valencia, IVO, Oncología
      • Valencia, Spain
        • Valencia,H.C.U.Valencia,Oncología
      • Birmingham, United Kingdom
        • City Hospital Birmingham Cancer Trials Team
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Coventry, United Kingdom
        • Arden Cancer Centre
      • Edinburgh, United Kingdom
        • Edinburgh Cancer Research UK Centre
      • London, United Kingdom
        • Royal Marsden Hospital
      • London, United Kingdom
        • Cancer Research UK and UCL Cancer Trials Centre
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Sutton, United Kingdom
        • Royal Marsden Hospital and Institute of Cancer Research
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • California
      • San Francisco, California, United States
        • Palo Alto Foundation Medical Group
    • Colorado
      • Aurora, Colorado, United States
        • University Of Colorado
    • Connecticut
      • New Britain, Connecticut, United States
        • The Hospital of Central Connecticut
    • Florida
      • Orlando, Florida, United States
        • Gynecologic Cancer Center
    • Illinois
      • Evanston, Illinois, United States
        • North Shore University
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins
      • Baltimore, Maryland, United States
        • Greater Baltimore Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • New Jersey
      • Voorhees, New Jersey, United States
        • MD Anderson at Cooper Cancer Center
    • New York
      • Albany, New York, United States
        • Womens Cancer Care Associates
      • Mineola, New York, United States
        • Winthrop Gynecologic Oncology Associates
    • Ohio
      • Hilliard, Ohio, United States
        • OSU JamesCare at Mill Run
    • Tennessee
      • Nashville, Tennessee, United States
        • Henry Joyce Cancer Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Aurora St Lukes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olaparib 300mg tablets
Taken orally twice daily
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.
Placebo Comparator: Placebo tablets
Taken orally twice daily
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
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.
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
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.
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).
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.
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (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.
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.
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.
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization 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
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
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
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)
Time Frame: Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.
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.
Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.
Efficacy of Olaparib by Time 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.
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 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.
Efficacy of Olaparib by Time 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.
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 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.
Efficacy of Olaparib by 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.
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 elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.
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.
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).
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.
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
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.
To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Professor E Pujade-Lauraine, MD, PhD, Universite de Paris Descartes, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2013

Primary Completion (Actual)

September 19, 2016

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimated)

June 11, 2013

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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