Prostate Cancer Clinical Trial

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Summary

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
PSA doubling time ≤ 9 months;
Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

Exclusion Criteria:

Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
Major surgery within 4 weeks before randomization;
Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
Known or suspected brain metastasis or active leptomeningeal disease;
History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1068

Study ID:

NCT02319837

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 209 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage Alaska, 99503, United States
Urological Associates of Southern Arizona, PC
Tucson Arizona, 85741, United States
Tower Hematology Oncology Medical Group
Beverly Hills California, 90211, United States
Cedars-Senai OCC Pharmacy
Los Angeles California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
University of California, Irvine Medical Center
Orange California, 92868, United States
Sutter Medical Group, Vascular & Varicose Vein Center
Roseville California, 95661, United States
Sutter Medical Group
Roseville California, 95661, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
University of California, Davis, School of Medicine
Sacramento California, 95817, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Foothills Urology, P.C.
Golden Colorado, 80401, United States
Eastern Connecticut Hematology Oncology Associates
Norwich Connecticut, 06360, United States
Johns Hopkins Kimmel Cancer Center/ Sibley Infusion
Washington District of Columbia, 20016, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland Florida, 33805, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Investigational Drug Service
Atlanta Georgia, 30322, United States
The Emory Clinic
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Northwestern Medical Group
Chicago Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
The University of Kansas Hospital
Kansas City Kansas, 66160, United States
Kansas City Urology Care, PA
Overland Park Kansas, 66211, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood Kansas, 66205, United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood Kansas, 66205, United States
GU Research Network/Wichita Urology Group
Wichita Kansas, 67226, United States
John Hopkins University Hospital
Baltimore Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
Baltimore Maryland, 21287, United States
Chesapeake Urology Research Associates
Towson Maryland, 21204, United States
Comprehensive Urology - Macomb Office
Macomb Michigan, 48044, United States
Comprehensive Urology - Royal Oak (Stephenson) office
Royal Oak Michigan, 48067, United States
GU Research Network, LLC / Urology Cancer Center
Omaha Nebraska, 68130, United States
VA Lahontan Valley Outpatient Clinic
Fallon Nevada, 89406, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison New York, 10604, United States
Memorial Hospital
New York New York, 10065, United States
Sidney Kimmel Center for Prostate and Urologic Cancers
New York New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12603, United States
Memorial Sloan Kettering Cancer Center Rockville Centre
Rockville Centre New York, 11570, United States
Associated Medical Professionals of New York, PLLC
Syracuse New York, 13210, United States
Memorial Sloan Kettering Cancer Center Nassau
Uniondale New York, 11553, United States
Duke Investigational Chemotherapy Services
Durham North Carolina, 27710, United States
Duke Nuclear Medicine
Durham North Carolina, 27710, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Alliance Urology Specialists, PA
Greensboro North Carolina, 27403, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati Ohio, 45212, United States
Mercy Health Jewish Hospital
Cincinnati Ohio, 45236, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States
Southwest Urology
Middleburg Heights Ohio, 44130, United States
OU Medical Center Presbyterian Tower
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73140, United States
Oregon Imaging Center
Eugene Oregon, 97401, United States
Oregon Urology Institute
Springfield Oregon, 97477, United States
Urologic Consultants of SE PA
Bala-Cynwyd Pennsylvania, 19004, United States
Keystone Urology Specialists
Lancaster Pennsylvania, 17604, United States
Lancaster Urology
Lancaster Pennsylvania, 17604, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia Pennsylvania, 19083, United States
Jefferson Medical Oncology
Philadelphia Pennsylvania, 19107, United States
Jefferson Urology Associates
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University Hospital, Bodine Buiding
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Medical Oncology
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
Nashville Tennessee, 37232, United States
Vanderbilt Unversity Medical Center, The Urology Clinic
Nashville Tennessee, 37232, United States
Urology Clinics of North Texas, PLLC
Dallas Texas, 75231, United States
Houston Metro Urology
Houston Texas, 77027, United States
Urology San Antonio Research
San Antonio Texas, 78229, United States
Henrico Doctor's Hospital
Henrico Virginia, 23229, United States
Virginia Urology
Richmond Virginia, 23235, United States
Urology of Virginia, PLLC.
Virginia Beach Virginia, 23462, United States
Genesis Cancer Care NSW
Gateshead New South Wales, 2290, Australia
Lismore Base hospital
Lismore New South Wales, 2480, Australia
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
Macquarie University
North Ryde New South Wales, 2109, Australia
Genesis Cancer Care
North Sydney New South Wales, 2060, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
GenesisCare North Shore
St Leonards New South Wales, 2065, Australia
The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
Australian Clinical Trials Pty Ltd
Wahroonga New South Wales, 2076, Australia
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Illawarra Cancer Care Centre
Wollongong New South Wales, 2500, Australia
Crown Princess Mary Cancer Centre
Westmead NEW, 2145, Australia
Icon Cancer Care Wesley
Auchenflower Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside Queensland, 4032, Australia
Icon Cancer Care South Brisbane
South Brisbane Queensland, 4101, Australia
Icon Cancer Foundation
South Brisbane Queensland, 4101, Australia
Icon Cancer Centre Southport
Southport Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Australian Urology Associates
Malvern Victoria, 3144, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
Hospital Barmherzige Schwestern Linz
Linz Upper Austria, 4010, Austria
Hospital Barmherzige Schwestern Linz, Department of Urology
Linz , 4010, Austria
Ordensklinikum Linz GmbH
Linz , 4020, Austria
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
Salzburg , 5020, Austria
Department of Radiology, University Hospital Salzburg, Austria
Salzburg , 5020, Austria
Department of Urology,Paracelsus Medical University Salzburg
Salzburg , 5020, Austria
AKH - Medizinische Universität Wien
Vienna , 1090, Austria
Department of Internal Medicine I, Medical university Vienna
Vienna , 1090, Austria
Hospital São Rafael S.A
Salvador BA, 41253, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba Parana, 81520, Brazil
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
Passo Fundo RS, 99010, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre RS, 90035, Brazil
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre RS, 90430, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre RS, 90610, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas SP, 13083, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre SP, 09060, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí/RS , 98700, Brazil
Prostate Cancer Centre
Calgary Alberta, T2V 1, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Vancouver Prostate Centre
Vancouver British Columbia, V5Z 1, Canada
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Nova Scotia Health Authority
Halifax Nova Scotia, B3H 2, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie Ontario, L4M 7, Canada
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Centre for Applied Urological Research
Kingston Ontario, K7L 3, Canada
Hotel Dieu Hospital
Kingston Ontario, K7L 5, Canada
Urology Associates/ Urologic Medical Research
Kitchener Ontario, N2N 2, Canada
London Health Sciences Centre - Victoria Hospital
London Ontario, N6A 5, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Urology South Shore Research
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2X 3, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Ultra-Med Inc.
Pointe-Claire Quebec, H9R 4, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec , G1R 2, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
Quebec , G1R 3, Canada
Aarhus University Hospital
Arhus N , 8200, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen N , 2200, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen , 2100, Denmark
Rigshospitalet, Dept of Radiology
Copenhagen , 2100, Denmark
Odense University Hospital
Odense C , 5000, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Helsingin yliopistollinen keskussairaala
Helsinki , 00290, Finland
Oulun yliopistollinen sairaala
Oulu , 90220, Finland
Satakunnan Keskussairaala
Pori , 28500, Finland
Seinaejoen Keskussairaala
Seinaejoki , 60220, Finland
Tampereen yliopistollinen sairaala
Tampere , 33520, Finland
ICO- site Paul Papin
Angers cedex 09 , 49933, France
Clinique Pasteur - Lanroze Service Pharmacie
Brest , 29200, France
Clinique Pasteur - Lanroze
Brest , 29200, France
CHD Vendée
LA ROCHE SUR YON cedex 9 , 85925, France
CHRU de Lille - Hopital Claude Huriez
Lille cedex , 59037, France
ICM Val d'Aurelle
Montpellier Cedex 5 , 34298, France
CHU de Nantes - Hotel Dieu
Nantes , 44000, France
Hopital Saint-Louis
Paris cedex 10 , 75475, France
Institut Mutualiste Montsouris
Paris Cedex 14 , 75674, France
CHP Saint-Gregoire
Saint-Gregoire , 35760, France
ICO - site Rene Gauducheau
Saint-Herblain cedex , 44805, France
Hia Begin
Saint-Mande , 94160, France
Hopital Foch
Suresnes , 92151, France
Institut Gustave Roussy
Villejuif cedex , 94805, France
Institut Gustave Roussy
Villejuif , 94800, France
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona , 26100, Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona , 26100, Italy
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona , 26100, Italy
UO di Oncologia,Ospedale Civile degli Infermi
Faenza RA , 48018, Italy
UO di Radiologia, Ospedale Civile degli Infermi
Faenza RA , 48018, Italy
UO di Oncologia, Ospedale Civile Umberto I
Lugo RA , 48022, Italy
Uo di Radiologia, Ospedale Civile Umberto I
Lugo RA , 48022, Italy
Laboratorio Farmaci Antiblastici, IRCCS Istituto
Meldola (FC) , 47014, Italy
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC) , 47014, Italy
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
Meldola (FC) , 47014, Italy
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
Napoli , 80131, Italy
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
Orbassano (TO) , 10043, Italy
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano (TO) , 10043, Italy
Servizio di Farmacia, Ospedale Santa Maria delle Croci
Ravenna , 48121, Italy
Servizio di Radiologia, Ospedale Santa Maria Delle Croci
Ravenna , 48121, Italy
UO di Oncologia Medica, Ospedale Santa Maria delle Croci
Ravenna , 48121, Italy
Farmacia Interna, Ospedale degli Infermi
Rimini , 47923, Italy
UO Oncologia, Ospedale degli Infermi
Rimini , 47923, Italy
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
Roma , 00152, Italy
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento , 38122, Italy
U.O. Medicina Nucleare, Ospedale Santa Chiara
Trento , 38122, Italy
U.O. Radiologia, Ospedale Santa Chiara
Trento , 38122, Italy
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan-si Gyeongsangnam-do, 50612, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun Jeollanam-do, 58128, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Severance Hospital. Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
Seoul , 06273, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
VU Medical Centrum, Department of Urology
Amsterdam , 1081 , Netherlands
Academisch Medisch Centrum
Amsterdam , 1105A, Netherlands
Gelderse Vallei Ziekenhuis
Ede , 6710 , Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven , 5623 , Netherlands
University Medical Centrum Groningen, Department Urologie
Groningen , 9713 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , 8934 , Netherlands
Maastricht University Medical Center, Department of Urology
Maastricht , 6229 , Netherlands
Antonius Ziekenhuis
Sneek , 8601 , Netherlands
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk , 80-95, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
Slupsk , 76-20, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
Slupsk , 76-20, Poland
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
Torun , 87-10, Poland
Centrum Medyczne Melita Medical
Wroclaw , 50-44, Poland
EMC Instytut Medyczny Spolka Akcyjna
Wroclaw , 54-14, Poland
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Banska Bystrica , 975 1, Slovakia
CUIMED, s.r.o., Urologicka ambulancia
Bratislava , 851 0, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Kosice , 041 9, Slovakia
Univerzitna nemocnica Martin
Martin , 036 5, Slovakia
UROEXAM, spol. s r.o.
Nitra , 949 0, Slovakia
MILAB
Presov , 080 8, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Zilina , 012 0, Slovakia
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa Barcelona, 08243, Spain
Hospital Universitari Son Espases
Palma de Mallorca Islas Baleares, 07010, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela LA Coruna, 15706, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
Barcelona , 08036, Spain
Hospital Universitario Puerta del Mar
Cadiz , 11009, Spain
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
Girona , 17007, Spain
Hospital Universitario de La Princesa
Madrid , 28006, Spain
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
Madrid , 28007, Spain
Centro Oncologico MD Anderson International Espana
Madrid , 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa , 08243, Spain
Complejo Hospitalario Universitario de Orense
Orense , 32005, Spain
Corporacio Sanitaria Parc Tauli
Sabadell , 08208, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Instituto Valenciano de Oncologia IVO
Valencia , 46009, Spain
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Goteborg , 413 4, Sweden
Skanes Universitetssjukhus
Malmo , 205 0, Sweden
Universitetssjukhuset Orebro
Orebro , 70 18, Sweden
Sodersjukhuset AB
Stockholm , 118 8, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm , 17176, Sweden
Norrlands Universitetssjukhus
Umea , 90 18, Sweden
Norrlands Universitetssjukhus
Umea , 90185, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan , 333, Taiwan
Ross Hall Hospital
Glasgow CITY OF Glasgow, G52 3, United Kingdom
Royal Devon & Exeter Hospital
Wonford, Exeter Devon, EX2 5, United Kingdom
Royal Free Hospital
London Greater London, NW3 2, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
Cancer Centre, Queen Elizabeth Hospital
Birmingham WEST Midlands, B15 2, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol , BS2 8, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 O, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1068

Study ID:

NCT02319837

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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