Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
SOLO-1
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.
3 other identifiers
interventional
450
15 countries
177
Brief Summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
Longer than P75 for phase_3
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
August 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2018
CompletedResults Posted
Study results publicly available
July 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2028
ExpectedDecember 10, 2025
November 1, 2025
4.7 years
April 30, 2013
May 9, 2019
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (8)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
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.
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
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
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Following first progression disease then assessed per local practice every 12 weeks until 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)
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
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
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.
- +3 more secondary outcomes
Study Arms (2)
Olaparib tablets p.o. 300mg twice daily
EXPERIMENTALOlaparib/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
Placebo tablets p.o. twice daily
PLACEBO COMPARATOROlaparib/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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- GOG Foundationcollaborator
- Myriad Genetic Laboratories, Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (177)
Clearview Cancer Institute
Huntsville, Alabama, United States
Providence Cancer Center
Anchorage, Alaska, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Kaiser Permanente
Oakland, California, United States
Kaiser Permanente
Roseville, California, United States
Stanford Women's Cancer Center
Stanford, California, United States
Babak Edraki
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
Univ of Connecticut Health Center
Farmington, Connecticut, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Gynecologic Cancer Center
Orlando, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Univ Chicago Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
Mishawaka, Indiana, United States
McFarland Clinic, P.C.
Ames, Iowa, United States
Norton Cancer Institute Research
Louisville, Kentucky, United States
Maine Medical Partners
Scarborough, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Gynecologic Oncology of West MI, PLLC
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, PA
Edina, Minnesota, United States
Mayo Clinic - Rochester, MN
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Womens Cancer Center of Nevada
Las Vegas, Nevada, United States
MD Anderson at Cooper Cancer Center
Camden, New Jersey, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Women's Cancer Care Associates
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center - New York
New York, New York, United States
Perlmutter Cancer Center
New York, New York, United States
Hope Women's Cancer Centers
Asheville, North Carolina, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Aultman Hospital
Canton, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, 43210, United States
Kettering Medical Center
Kettering, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford Clinic Women's Health
Sioux Falls, South Dakota, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center of Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States
Aurora Baycare Medical Center
Green Bay, Wisconsin, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States
Mercy Hospital for Women
Heidelberg, Australia
The Royal Womens Hospital
Parkville, Australia
Prince of Wales Hospital
Randwick, Australia
Centro Diagnóstico Barretos
Barretos, Brazil
Hospital Araujo Jorge
Goiânia, Brazil
Centro de Novos Tratamentos Itajai
Itajaí, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre
Porto Alegre, Brazil
Hospital de Base São José do Rio Preto
São José do Rio Preto, Brazil
Centro de Referencia da Saude da Mulher
São Paulo, Brazil
Instituto do Câncer de São Paulo
São Paulo, Brazil
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
CHUM - Hopital Norte-Dame
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hotel-Dieu de Quebec
Québec, Quebec, Canada
Beijing Cancer Hospital
Beijing, China
The Tumor Hospital affiliated to China Medical Science Insti
Beijing, China
1st Hospital of Jilin university
Changchun, China
Jilin Provincial Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
West China Hospital Affiliated to Sichuan University
Chengdu, China
ChongQing Cancer Hospital
Chongqing, China
Research Site
Guangzhou, 510060, China
Women's Hospital, Zhejaing University School of Medicine
Hangzhou, China
The Tumour Hospital of Harbin Medical University
Harbin, China
Zhejiang Cancer Hospital, Huangzhou
Huangzhou, China
JINAN, Qi Lu Hosp. of SD Univ.
Jinan, China
Obstetris and Gynecology Hospital of Fudan University
Shanghai, China
Shanghai Cancer Hospital of Fudan University
Shanghai, China
The First Affiliated Hospital of Soochow Universit
Suzhou, China
First affiliated hospital college of XianJiaotong University
Xi'an, China
Institut Bergonie
Bordeaux, France
CAC François Baclesse
Caen, France
69LYON, C Bérard, Onco
Lyon, France
Centre Catherine de Sienne
Nantes, France
75PARIS, H Tenon, Onco
Paris, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Rambam Health Care Campus
Haifa, Israel
Sapir Medical Centre
Kfar Saba, Israel
Rabin MC
Petah Tikva, Israel
Tel-Aviv Sourkasy Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Centre
Tel Litwinsky, Israel
Bari- Istituto Tumori Giovanni Paolo II
Bari, Italy
Azienda Ospedaliera "Cannizzaro"
Catania, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Per Cura Tumori - Milano
Milan, Italy
Istituto Nazionale Tumori Fondazione Pascale
Naples, Italy
Istituto Oncologico Veneto Irccs
Padua, Italy
Istituto Regina Elena-Polo Oncologico Ifo
Roma, Italy
Policlinico Universitario A. Gemelli
Roma, Italy
Hyogo CC
Akashi-shi, Japan
National Cancer Center Hosp
Chūōku, Japan
NHO Kyushu CC
Fukuoka, Japan
Saitama Med. Univ. Int. Med. C
Hidaka-shi, Japan
NHO Shikoku Cancer Center
Matsuyama, Japan
Niigata Univ. Med. Dent.
Niigata, Japan
Hokkaido University Hospital
Sapporo, Japan
Shizuoka Cancer Center
Sunto-gun, Japan
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
Grzepnica, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
Warsaw, Poland
Udmurtia Republic Clinical Oncology Center
Izhevsk, Russia
Chemotherapy Department, Russian Cancer Research Centre
Moscow, Russia
State Institution of Heath Omsk Regional Oncology Dispensary
Omsk, Russia
Cancer Research Institute
Saint Petersburg, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, Russia
St.Petersburg City Oncology Dispensary, Dept. Gynecology
Saint Petersburg, Russia
Research Institute of Oncology RAMS
Tomsk, Russia
National Cancer Center
Goyang-si, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Barcelona,H.Vall d´Hebrón,Oncología
Barcelona, Spain
Córdoba,H.Reina Sofía,Oncología
Córdoba, Spain
H.Llobregat,ICO-Duran i Reynals,Oncología
Hospitalet deLlobregat(Barcelo, Spain
Madrid, MD Anderson, Oncología
Madrid, Spain
Madrid,H.U.La Paz,Oncología
Madrid, Spain
Valencia, IVO, Oncología
Valencia, Spain
Valencia,H.C.U.Valencia,Oncología
Valencia, Spain
City Hospital, Birmingham, Cancer Trials Team
Birmingham, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Arden Cancer Centre
Coventry, United Kingdom
Edinburgh Cancer Research UK Centre
Edinburgh, United Kingdom
Cancer Research UK and UCL Cancer Trials Centre
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Royal Marsden Hospital and Institute of Cancer Research
Sutton, United Kingdom
Related Publications (6)
Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
PMID: 39695768DERIVEDDiSilvestro 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.
PMID: 36082969DERIVEDTattersall 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.
PMID: 35170751DERIVEDBanerjee 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.
PMID: 34715071DERIVEDFriedlander 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.
PMID: 33862001DERIVEDMoore 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.
PMID: 30345884DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The data presented based on the March DCO (17 May 2018) are not the final analyses for OS, TFST, TSST, and TDT. Further analyses of these (numbered as endpoints 2, 6, 7 and 8 in Outcome Measures section) will be performed as planned in the protocol and SAP when the pre-specified number of OS events are achieved.
Results Point of Contact
- Title
- Elizabeth Lowe
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Paul DiSilvestro, MD
Women & Infants Hospital, Providence, Rhode Island, USA
- PRINCIPAL INVESTIGATOR
Prof Kathleen Moore, MD
University of Oklahoma Health Sciences Center, Oklahoma City, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 30, 2013
First Posted
May 3, 2013
Study Start
August 26, 2013
Primary Completion
May 17, 2018
Study Completion (Estimated)
August 29, 2028
Last Updated
December 10, 2025
Results First Posted
July 9, 2019
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.