title: Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.

summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL (2.6 mmol/L).

title: Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_country:
Finland
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Poland
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Black Hills Cardiovascular-Regional Health Research

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o., sp.k.

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location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

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location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed

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location_facility: Admin & Storage only:Northwest Heart Center

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location_facility: MUDr. Antonin Dufka, kardiologicka ambulance

location_facility: University of Iowa College of Public Health - Preventive Intervention Center

location_facility: General Hospital Of Ningxia Medical University

location_facility: Dr. Mistodie Cristina Victoria MD, Office of

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location_facility: Synexus Polska Sp. z o.o Oddzial w Poznaniu

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location_facility: SC Centrul Medical Policlinico Di Monza SRL, Cardiologie

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location_facility: Santa Casa de Misericordia de Votuporanga

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital - New

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Atlanta Center for Clinical Research / Internal Medicine

location_facility: Brian Y.L. Wong Medicine Professional Corporation

location_facility: Allina Health System, dba Abbott Northwestern Hospital

location_facility: Hospital Universitario De Monterrey- "Doctor Jose Eleuterio Gonzalez"

location_facility: Fundacion Cardiovascular De Colombia - Instituto del Corazón Floridablanca

location_facility: Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders

location_facility: Division Of cardiology,Department of Medicine,Faculty Of Medicine,Chulalongkorn University

location_facility: State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary"

location_facility: The Queen Elizabeth University Hospital- NHS Greater Glasgow and Clyde

location_facility: "Prof. Dr. N.C. Paulescu" National Institute of Diabetes, Nutrition and Metabolic Diseases,

location_facility: Fakultni poliklinika Vseobecne fakultni nemocnice v Praze

location_facility: Mercy Health Youngstown, LLC d/b/a St. Elizabeth Youngstown Hospital

location_facility: Retreat Cardiology LLC, dba Cardiology Associates of Richmond

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Baskent University, Adana Yuregir Training & Research Hospital

location_facility: Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s.

location_facility: State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital No. 10"

location_facility: Region Sjaelland Sygehus Nord, Koge Sygehus

location_facility: Joondalup Cardiovascular Trials Foundation Inc.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie, Ambulatoria

location_facility: Heart Center, Songklanagarind Prince of Songkla University

location_facility: PMG Research,Inc d/b/a PMG Research of Knoxville

location_facility: Jeleniogorskie Centrum Chorob Serca, Przychodnia Kardiologiczna, Poradnia Kardiologiczna

location_facility: Regionshospitalet Silkeborg, Hjerte Projektkontor

location_facility: Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

location_facility: Podoleanu G. Cristian-Gheorghe-Calin - Cardiology Medical Practice

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

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location_facility: Private Practice 'Cardiovascular Detection Center'

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Synexus Watermeyer Clinical Research Centre

location_facility: Dr. Pop Calin Florin - Cabinet Cardiologie

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Malgorzata Biedrzycka

location_facility: University of Texas Southwestern Medical Center

location_facility: Synexus North East Clinical Research Centre - Hexham General Hospital

location_facility: "SBHI of Novosibirsk ""City Clinical Hospital of Emergency Medical Care # 2"""

location_facility: BV Medical, s.r.o. Diabetologicka ambulancia,

location_facility: Ospedale Civile Regionale San Martino, Belluno

location_facility: Green and Seidner Family Practice Associates

location_facility: SBEI of HPE I. M. Sechenov First Moscow State Medical University, UKB #2

location_facility: AOU Policlinico "Mater Domini" UOC di Medicina interna

location_facility: Heart Institute, Bikur Cholim Campus, Shaare Zedek Medical Center

location_facility: Karlkliniken, Skanes Universitetssjukhus i Malmo

location_facility: Shuali Community Clinic, Clalit Health Services

location_facility: Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota

location_facility: Philadelphia Health Associates-Adult Medicine

location_facility: Austin Health - Heidelberg Repatriation Hospital

location_facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Egitim ve Arastirma Hastanesi

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospital Inovamed Cuernavaca (Emergencies)

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: S.C. Centrul Medical "Sanatatea Ta" S.R.L.

location_facility: Howlands Clinic - Queen Elizabeth II Hospital

location_facility: State Institution of Healthcare "Regional Clinical Hospital"

location_facility: The Red Porto cabin, The James Cook University Hospital

location_facility: Instituto de Cardiologia y Cirugia Cardiovascular - Fundacion Favaloro

location_facility: Centro de Pesquisas Medicas Basica e Clinica LTDA

location_facility: Hospital Universitario La Paz; Unidad Metabolico-Vascular

location_facility: St. Mary's Medical Center (Primary Practice Site)

location_facility: Solutions Through Advanced Research, Inc.

location_facility: CARDSEARCH/CARDRESEARCH - Cardiologia Assistencial e de Pesquisa LTDA

location_facility: Instituto Medico CENICLAR - Central de Investigaciones Clinicas Argentina -Sanatorio de la Mujer

location_facility: Roodepoort Medicross Clinical Research Centre

location_facility: Lahoja Asociacion para la Investigacion y Farmacovigilancia S.C.

location_facility: Florida Hospital Cardiovascular Institute

location_facility: Sydvestjysk Sygehus, Hjertemedicinsk Projektgruppe

location_facility: Centro de Especialidades Medicas del Estado de Veracruz

location_facility: Federal state budget institution of healthcare Saint-Petersburg clinical hospital of Russian Academy

location_facility: "Prywatny Gabinet Kardiologiczny" Dr N.Med. Maciej Kosmider

location_facility: Division of Cardiology, Department of Medicine, Faculty of Medicine, Songklanagarind Hospital,

location_facility: Acacia Medical Research Institute, LLC/Royal Oaks Medcical Home and Wellness Clinics

location_facility: State Regional Budgetary Healthcare Institution

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: Fundacion Centro de Obesidad y Metabolismo COMETA

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, l.interna klinika

location_facility: Centro de Atencion e Investigacion en Factores de Riesgo Cardiovascular Omega S.C

location_facility: State Budgetary Institution "Ryazan Regional Clinical Hospital"

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Kardiyoloji Bolumu

location_facility: UN Bratislava Nemocnica Sv. Cyrila a Metoda, kardiologicka ambulancia 1

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare "City Hospital #23"

location_facility: Gulf Coast Endocrine and Diabetes Center

location_facility: CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Sociedade Hospitalar Angelina Caron/Hospital e Maternidade Angelina Caron

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: MetroWest Medical Center - Pharmacy Department

location_facility: Landa Specjalistyczne Gabinety Lekarskie

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: Clinical Research Institute of Northern Virginia

location_facility: Municipal Budgetary State Healthcare Institution "City Clinical Hospital #6"

location_facility: Helsingin yliopistollinen keskussairaala, Sisaetaudit ja kuntoutus, Biomedicum 2U

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location_facility: Diabmed Dr. Popescu Alexandrina SRL, Diabet, Nutritie, Boli Metabolice

location_facility: Recep Tayyip Erdogan University School of Medicine, Training & Research Hospital

location_facility: Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran

location_facility: Kirov Regional State Budgetary Healthcare Institution "Kirov City Clinical Hospital #1"

location_facility: Ben Yair Community Clinic - Clalit Health Services

location_facility: Centre Hospitalier Universitaire de Sherbrooke- Hotel-Dieu

location_facility: Centro Hospitalario Mac, S.A. de C.V. (Emergencies)

location_facility: Cedir S.A - Centro De Diagnostico Y Rehabilitacion S.A.

location_facility: Hospital General Universitario de Valencia

location_facility: Endocrine Lipid Diabetes Research Institute

location_facility: Dr. Kapil M. Bhagirath Medical Services Corporation

location_facility: Clinical Research Advantage, Inc./Skyline Medical Center, PC

location_facility: IP + Dry ice deliveries Sugar Lakes Family Practice

location_facility: Quanta Diagnostico e Terapia / Medicina Nuclear Alto da XV

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: The Royal Liverpool and Broadgreen -University Hospitals NHS Trust

location_facility: Institute of Cardiovascular Diseases Timisoara

location_facility: ProMedica Northwest Ohio Cardiology Consultants

location_facility: Federal State Budget Institution "Out-patient Clinic #3" of Russian Federation,

location_facility: Wake Forest University School of Medicine

location_facility: Jacksonville Center for Clinical Research

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"

location_facility: Buffalo Medical Group - Research Department

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

location_facility: Shri Krishna Hrudayalaya and Critical Care Centre

location_facility: CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo

location_facility: Ospedale Santa Maria della Misericordia Azienda ULSS 18 of Rovigo

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.

location_facility: Federal State Budgetary Educational Institution of Higher Education

location_facility: Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Spolka jawna

location_facility: Midwest Heart & Vascular Specialists, LLC

location_facility: Department of Clinical Medicines and Cardiovascular Sciences, Universita "Federico II" di Napoli

location_facility: PMG Research of Rock Mount, LLC - Patient Intake

location_facility: Kardiocentrum Nitra s.r.o., kardiologicka ambulancia

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Hampton Roads Center for Clinical Research

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.

location_facility: BKS Research Kft., Albert Schweitzer Korhaz

location_facility: Azienda Ospedaliera S'Andrea di Roma - UOC Cardiologia

location_facility: Centrum Opieki Diabetologiczno-Endokrynologicznej i Ginekologiczno-Polozniczej

location_facility: Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

location_facility: William P. Clements Jr. University Hospital

location_facility: University Hospital Brussels- Diabeteskliniek

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes S.A. de C.V.

location_facility: "SAHI of Kemerovo ""Regional Clinical Hospital of Emergency Medical Care n.a. M.A Podgorbunsky """

location_facility: Hospital de Alta Complejidad "Pte. Juan Domingo Peron"

location_facility: John V. Bernard, MD dba Wellness and Research Center

location_facility: State Healthcare Institution of Yaroslavl Region "Clinical Hospital #8"

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Spitalul Clinic Judetean De Urgenta Braila(Braila County Clincal Emergency Hospital)

location_facility: Memorial Hermann Hospital, Texas Medical Center- UT Health Clinical Research Unit

location_facility: Hopital Cardiovasculaire Et Pneumologique Louis Pradel

location_facility: Apex Heart Institute (A Unit of TCVS Pvt. Ltd)

location_facility: Caja de Compensacion Familiar CAFAM, Sede Centro de Atencion en Salud CAFAM FLORESTA

location_facility: Northwest Houston Clinical Research, PLLC

location_facility: Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Gemeinschaftspraxis Dres. Dirk Weber, Ulrich Weber, Heiner Saueressig, Birte Turner und Georg

location_facility: London Road Diagnostic Clinic and Medical Centre

location_facility: FGM-Clinica Paulista de Doencas Cardiovasculares

location_facility: Detweiler Family Medicine & Associates, PC

location_facility: Clinical Research Advantage, Inc./Simon Williamson Clinic

location_facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi 251 Pomorska

location_facility: Azienda Ospedaliera Universitaria Santa Maria Della Misericordia

location_facility: Austin Institute for Clinicla Research,Inc.

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: West Jefferson Heart Clinic of Louisiana New Orleans Physician Services, Inc.

location_facility: MHI "City Clinical Hospital #12" of the Healthcare Committee

location_facility: National Cheng Kung University (NCKU) Hospital

location_facility: State Autonomous Institution of Healthcare of the Tyumen region Tyumen Institute of Therapy

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie,

location_facility: Glacier View Research Institute, Cardiology

location_facility: Rothwell and Desborough Healthcare Group

location_facility: California Medical Research Associates Inc.

location_facility: Saint Luke's Lipid and Diabetes Research Center

location_facility: Optimamed Specjalistyczne Gabinety Lekarskie

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: Presidioospedaliero di san dona 'di PIAVE

location_facility: Cardiovascular Research Foundation of Southern California

location_facility: FSHI "Medical and Sanitary Unit of the Ministry of Internal Affairs of Russia across Kemerovo region

location_facility: Galilee Medical Center, Cardiology Department

location_facility: Staedtische Kliniken Bielefeld Gem. GmbH - Klinikum Mitte

location_facility: State Budgetary Institution of Healthcare of Kaluga Region "Kaluga Regional Hospital"

location_facility: South Florida Clinical Research Institute

location_facility: Clinique des maladies lipidiques de Quebec

location_facility: Hospital General Comarcal de Elda Virgen de la Salud

location_facility: Klinik Am See - Klinik Am See - Rehabilitationszentrum Fur Innere Medizin

location_facility: Hopital Arnaud de Villeneuve - CHU Montpellier

location_facility: Department of Neurology & Sagol Neuroscience Center

location_facility: Broward Health Medical Center (BHMC) (Broward General Medical Center (BGMC))

location_facility: Memorial Hermann Hospital, Texas Medical Center

location_facility: Regional Budgetary Healthcare Institution "Cardiology Dispensary"

location_facility: SBHI of Saint-Petersburg "City Hospital # 38 n.a. N.A. Semashko"

location_facility: HealthEast St. Joseph's Hospital Pharmacy

location_facility: Klinikum Fur Herz- & Kreislauferkrankungen

location_facility: CPClin- Centro de Pesquisas Clinicas Ltda./Clinica Dr. Freddy Goldberg Eliaschewitz

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Cardiology Unit, Department of Medicine, Faculty of Medicine,Ramathibodi Hospital,Mahidol University

location_facility: The affiliated Hospital of Xuzhou Medical College

location_facility: Centro de Investigacion Clinica Avanzada y Multidisciplinaria CICLAM

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: Hospital Universitario de Santiago de Compostela

location_facility: Hospital Universitario Sant Joan de Reus

location_facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

location_facility: Comed Care Empresa de Atendimento Clinico Geral - LTDA - Hospital Total Care

location_facility: Cranbrook Cardiology Research Associates

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Oddzial

location_facility: Moscow State Healthcare Institution "City clinical hospital n.a. S.P.Botkin"

location_facility: Hospital Regional Universitario de Malaga

location_facility: Gefen Institute for Research and Cardiac Health

location_facility: Hospital Lomas de San Luis Intemacional (Emergencies)

location_facility: Maerkische Kliniken GmbH, Klinikum Luedenscheid, Innere III

location_facility: Bogna Gabrylewicz Andrzej Ochala Unimed s.c.

location_facility: IKF Institut fuer klinische Forschung Frankfurt

location_facility: Fundacion del Caribe Para La Investigacion Biomedica - Fundacion BIOS

location_facility: Bochum Research Centre-Synexus Clinical Research GmbH

location_facility: Intercoastal Medical Group (Drug Shipment Address and Administrative)

location_facility: AOU Policlinico "P. Giaccone" Dipartimento delle Patologie Emergenti, Unita di Medicina Interna

location_facility: The Center for Diabetes and Endocrine Care

location_facility: The Office of Roberto J. Ayala-Rios, MD - Research Center and Private Practice (DMRA LLC)

location_facility: Division of Cardiology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol

location_facility: Grand Hopital de Charleroi, Site St-Joseph

location_facility: Cardiology Research Associates of New Brunswick

location_facility: Altamira Family Medicine And Research Institute

location_facility: State Budgetary Educational Institution of Highest Professional Education "Siberian State Medical

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Office of Maxine E. Hamilton, MD, PA

location_facility: Marek Piepiorka Gabinet Kardiologiczno - lnternistyczny

location_facility: Centro de Investigacion Medica Integral S.C.

location_facility: Spitalul Universitar De Urgenta Militar Central, Dr. Carol Davila

location_facility: Saint Petersburg State Budgetary Institution of Healthcare Municipal hospital

location_facility: Canadian Centre for Research on Diabetes

location_facility: Instituto Jaqueline Scholz Issa e Mario Issa de Cardiologia LTDA

location_facility: McGlone Practice Baillieston Health Centre

location_facility: HBA S/A ASSISTENCIA MEDICA E HOSPITALAR-Hospital da Bahia

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: Municipal Budgetary Institution of Healthcare of Novosibirsk

location_facility: SBEI of HPE Kazan State Medical University on the base of SBHI Clinical Hospital No.2

location_facility: Philippe R. Beaudry Medicine Professional Corporation

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: NZOZ PRZYCHODNIA SPECJALISTYCZNA Andrzej Wittek Henryk Rudzki s.c.

location_facility: Cardiovascular Clinical Research Institute

location_facility: Clinical Trials Unit,Bay of Plenty(BOP) Clinicla School

location_facility: Southeast Texas Cardiology Associates II, L.L.P.

location_facility: FSBEI of HE Kazan State Medical University on the base of SBHI Clinical Hospital No.2

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski

location_facility: Gemeinschaftspraxis Drs Haggenmiller/Jeserich, Kardiologie, Angiologie, Innere Medizin

location_facility: Solano & Terront Servicios Medicos Ltda-Establecimiento Comercial UNIENDO

location_facility: Hospital Universitario San Cecilio de Granada

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Federal State Budgetary Institution "Research Institute of Therapy and Preventive Medicine" of

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Tyumen Cardiology Research Center-branch of the Tomsk NRMC

location_facility: Klinik und Poliklinik fuer Innere Medizin B - Kardiologie, Angiologie, Pulmologie

location_facility: (For IP storage only)The University of Texas Southwestern Medical Center

location_facility: Memorial Hospital: University of Colorado Health

location_facility: Hospitalsenheden Midt, Regionshospital Viborg

location_facility: POLIKUM Institut GmbH, Polikum Berlin Friedenau

location_facility: Schwerpunktpraxis Dr. Luedemann fuer Diabetes Gefaess- und Ernaehrungsmedizin

location_facility: Inner Mongolia Autonomous Region People's Hospital

location_facility: New Orleans Center for Clinical Research

location_facility: Instituto de Terapeutica Experimental y Clinica (INTEC) Centro Universitario de Ciencias de la Salud

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Municipal Budgetary Institution of Healthcare

location_facility: Dokuz Eylul Univesitesi Tip Fakultesi Hastanesi

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Diabet Zaharat, Nutritie si Boli Metabolice

location_facility: Cardiology Partners Clinical Research Institute

location_facility: The First Affiliated Hospital Of Harbin Medical University

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: Clinical Research Associates of Central PA

location_facility: Clinresco Centres (Pty) Ltd-Central Professional Suits

location_facility: Dr. Mohan Babapulle Medicine Professional Corporation

location_facility: Federal state budgetary institution Research institute of complex problems

location_facility: Vita Health & Medical Center, Inc./Concept Clinical Trials, LLC

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Stroke Prevention & Atherosclerosis Research Centre (SPARC)-Siebens-Drake Research Institute

location_facility: DRK Kliniken Berlin Kopenick, Zentrum Klinische Forschung

location_facility: Mid-Cumberland Infectious Disease Consultants, PLC

location_facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda.

location_facility: INTERCARD Sp. z o.o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Krosnie

location_facility: Via Medica - Clinica Medica Integrada Ltda - Barroso e Sebba Ltda

location_facility: VA North Texas Health Care System - Dallas VAMC

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

location_facility: Abertawe Bro Morgannwg University Local Health Board

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Centrum Medyczne Warszawskiego Uniwersytetu Medycznego Sp. z o.o

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Hospital de Messejana Dr Carlos Alberto Studart Gomes

location_facility: University hospitals Leuven - Cardiology department

location_facility: Groupe Hospitalier de Pellegrin Hopital Pellegrin

location_facility: Aster Aadhar Hospital (Prerana Hospital Ltd.)

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie, Oddzial Kardiologii

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, III. Belgyogyaszat-Kardiologiai Osztaly

location_facility: Heart Institute, Hillel Yaffe Medical Center

location_facility: GBOU VPO Siberian State Medical University Ministry of Healthcare of the Russian Federation

location_facility: Gemeinschaftspraxis fuer Kardiologie Dres. Med. Willgeroth/Wetzel

location_facility: Pharmacology International Research, Inc.

location_facility: Clinical Research Advantage, Inc. (Administrative Mailing Only)

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Hospital General Universitario de Alicante; Servicio Cardiologia

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Policlinico Umberto I di Roma - DAI Malattie Cardiovascolari e Respiratorie

location_facility: Centro De Investigaciones Clinicas Del Litoral S.R.L.

location_facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona U.O.C. UTIC

location_facility: Lillehei Clinical Research Unit, University of Minnesota

location_facility: Divisione di Cardiologia con UTIC ed Emodinamica

location_facility: Instituto de Hematologia y Medicina Clinica "Dr. Ruben A. Davoli"

location_facility: Klinikum fuer Herz- & Kreislauferkrankungen

location_facility: Arizona Endocrine and Rheumatology Associates

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: The First Affiliated Hospital of Habrin Medical University

location_facility: The First Affiliated Hospital Of Zhengzhou University

location_facility: Hospital Provincial Dr. Jose Maria Cullen

location_facility: Instituto de Conhecimento, Ensino e Pesquisa (Administrative local)

location_facility: Instituto de Cardiologia de Corrientes "Juana Fca. Cabral"

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Centro Cientifico Asistencial Jose Luis Accini S.A.S.

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Consultorios Asociados de Endocrinologia e Investigacion Clinica Aplicada

location_facility: North Ohio Heart Center (Administrative Only)

location_facility: Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny Boguslaw Derlaga

location_facility: University of Arizona Medical Center South Campus

location_facility: Metro West Medical Center Research Clinic

location_facility: County Clinical Emergency Hospital Oradea

location_facility: Dept."Medicina lnterna e Specialita Mediche" dell' Universita degli

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Department of Cardiology, Lyell McEwin Hospital

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: University of Texas Health Science Center San Antonio

location_facility: Global Trial Research Center S.A. de C.V.

location_facility: Hospital Universitario Principe de Asturias

location_facility: Clinical Research Advantage, Inc./Medical and Procedural Specialists of Illinois

location_facility: Dr JM Engelbrecht Trial Site-Vergelegen Mediclinic

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.

location_facility: The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital

location_facility: Hospital Angeles Culiacan (Emergencies Only)

location_facility: Podlaski Osrodek Kardiologii Janusz Korecki

location_facility: Unicare Heart Institute & Research Center

location_facility: SC Clinica Medicala Synexus SRL, Medicina Interna

location_facility: INTERCARD Sp. z. o. o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Nowym Targu

location_facility: Westside Medical Associates of Los Angeles

location_facility: Insituto de Cardiologia de Santa Catarina

location_facility: Sir Charles Gairdner Hospital, Heart Research Institute

location_facility: Caprock Cardiac Center Research Institute Inc.

location_facility: NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp. z.o.o.

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: Southern Health & Social Care Trust, Craigavon Area Hospital

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: State Budgetary Healthcare Institution of Nizhegorodskaya Region

location_facility: Advanced Clinical Research of Miami (ACROM) International

location_facility: Clinical Research Advantage, Inc./Michigan Avenue Internists

location_facility: Consultorio Dr. Leocadio Gerardo Munoz Beltran

location_facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital of Emergency

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "City Alexandrovskaya Hospital"

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Daegu Catholic University Medical Center

location_facility: Hospital Parana - Parana Medical Research Center - MARIMED SERVICOS MEDICOS S.A.

location_facility: Federal State Budgetary Institution of Healthcare Hospital of Russian Academy of Sciences

location_facility: Fakultna Nemocnica s poliklinikou Nove Zamky

location_facility: DIKa centrum s.r.o., Kardiologicka a interni ambulance

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: State Budgetary Healthcare Institution "Research Institution - Regional Clinical Hospital #1

location_facility: ILAIM Instituto Latinoamericano de Investigaciones Medicas

location_facility: Limited Liability Company International Medical Centre SOGAZ

location_facility: Liga Mineira de Ressuscitacao Cardiopulmonar

location_facility: Federal State Budgetary Institution "Russian Cardiology Research And Production Complex" Of Ministry

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Regional Budgetary Healthcare Institution "Kursk City Clinical Emergency Hospital"

location_facility: The Heart & Vascular Institute of Florida

location_facility: Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Specjalistyczna Praktyka Lekarska Piotr Kubalski

location_facility: Novant Health Heart and Vascular Institute

location_facility: A.karahisar Kocatepe Universitesi Hastanesi Ahmet Necdet Sezer Uygulama ve Arastirma Hastanesi

location_facility: Clinical Research Advantage, Inc. / Family Medicine Associates

location_facility: Research Institute of the Carolinas of PiedmontHealthcare, PA

location_facility: "OSTEO-MEDIC" s.c. Artur Racewicz, Jerzy Supronik

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02

location_facility: Royal Bolton Hospital - Bolton Nhs Foundation Trust

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Centro de Diagnostico Cardiologico LTDA.

location_facility: Hospital Universitario San Juan de Alicante

location_facility: CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.

location_facility: The Office of Daniel W. Gottlieb, MD, PS

location_facility: Affiliate of the Federal State Budgetary Institution Scientific Research Institute of Cardiology

location_facility: Centro de Investigaciones Clinicas "Instituto del Corazon"

location_facility: Elisabeth-TweeSteden Ziekenhuis (previously named St. Elisabeth Ziekenhuis)

location_facility: The University of Texas Health Science Center at Houston- UT Physicians

location_facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University"

location_facility: Cicemo - Consultorio de Investigaciones Clinicas E.M.O. S.R.L.

location_facility: Northeast Iowa Medical Education Foundation

location_facility: Rutgers Biomedical and Health Sciences-Robert Wood Johnson Medical School

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas Ltda

location_facility: Synexus Leipzig Clinical Research Centre

location_facility: Conquest Hospital - East Sussex Healthcare NHS Trust

location_facility: CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

location_facility: Hospital Universitário Sao José / FELUMA - MG

location_facility: CCBR - Centro de Pesquisas e Analises Clinicas LTDA

location_facility: Loema Medicina e Bem Estar- Centro Especializado em Cardiologia Ltda

location_facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, l.intema klinika

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Pharmacology and Clinical Research S.A. de C.V.

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: CARDIO D&R s.r.o. , Kardiologicka ambulancia

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: County Clinical Emergency Hospital Sibiu

location_facility: Hospital General Universitario Morales Meseguer

location_facility: State Budgetary Healthcare Institution "Region Clinical Hospital #3"

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Nemocnice Pardubickeho kraje, a.s., Svitavska nemocnice

location_facility: Klinik fur Innere Medizin, Kardiologie und Angiologie MediClin Herzzentrum Lahr/Baden.

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: SBHI of Moscow city "City Clinical Hospital #15 n.a. O.M. Filatova"

location_facility: "Hospital Central ""Dr. Ignacio Morones Prieto"""

location_facility: Centre Integre de Sante et de services sociaux de Chaudiere-Appalaches (CISSS-CA)

location_facility: Klinika hematologie a transfuziologie, Univerzitna nemocnica Martin

location_facility: T. Joseph Raoof, Md, Inc/Encino Research Center

location_facility: AOUI di Verona - Ospedale Civile Maggiore Borgo Trento

location_facility: Centrum kardiovaskularni prevence 1. LF UK a TN

location_facility: Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika

location_facility: Hospital Universitario Ciencias Medicas / Fundacao Educacional Lucas Machado

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Non-State Institution of Healthcare "Central Clinical Hospital #6 OAO "RZhD"

location_facility: Irmandade da Santa Casa de Misericordia de Curitiba - Hospital Santa Casa de Misericordia

location_facility: MEDI M&M s.r.o., Ambulancia vnutorneho lekarstva

location_facility: Baylor University Medical Center / Department of Pharmacy

location_facility: DIAMEL, s.r.o., Diabetologicka ambulancia

location_facility: Clinica Privada de Especialidades Medicas

location_facility: Jardines Hospital de Especialidades S.A de C.V

location_facility: METABOL KLINIK s. r.o., Ambulancia pre diabetologiu, poruchy latkovej premeny a vyzivy

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, S.C.

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

location_facility: State Healthcare Institution "City Clinical Hospital #51 of Healthcare Department of Moscow City"

location_facility: LMC Diabetes & Endocrinology (Thornhill)

location_facility: Hospital Universitario - Associacao Educadora Sao Carlos - AESC

location_facility: Stredoslovensky Ustav Srdcovych A Cievnych Chorob A.S.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Gdanskie Centrum Zdrowia, Poradnia Kardiologiczna

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran"

location_facility: INGOH - Instituto Goiano de Oncologia e Hematologia

location_facility: Federal State Budgetary Institution "State Research Center for Preventive Medicine" of the Ministry

location_facility: Dumlupinar Universitesi Kutahya Evliya Celebi EAH

location_facility: UNIFESP - Hospital Sao Paulo - Setor de Lipides, Aterosclerose e Biologia Vascular

location_facility: Endiamed s.r.o. Nestatna diabetologicka a endokrinologicka ambulancia

location_facility: Cardiovascular Associates of the Southeast, LLC

location_facility: Hospital Clinico Universitario Miguel Servet; Medicina Interna

location_facility: The 2nd Affiliated Hospital Of Harbin Medical University

location_facility: Clinical Research Advantage, Inc. (IP Shipment and Research Site)

location_facility: Liga Mineira de Ressucitacao cardiopulmonar

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Clinphenomics Gmbh & Co Kg, Studienzentrum

location_facility: Clinical Research Advantage, Inc. / Cassidy Medical Group - Vista

location_facility: A.O. di Reggio Emilia Arcispedale "S. Maria Nuova"/IRCCS

location_facility: Instituto de Diabetes Obesidad y Nutricion, S.C.

location_facility: Consultorio de Endocrinologia y Nutriologia

location_facility: Division of Cardiology, Department of medicine,Faculty of Medicine, Srinagarind Hospital, Khon Kaen

location_facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

location_facility: Seoul National University Bundang Hospital

location_facility: Investigacion en Salud y Metabolismo S.C.

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Premier Health Specialists, Inc (dba Dayton Heart Center)

location_facility: Ribo Research, LLC dba Peninsula Research

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Research Institute of South Florida, Inc.

location_facility: Clinical Trial Center (CTC)/Centrum foer klinisk proevning

location_facility: MedStar Chesapeake CardioVascular Associates

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego Klinika Kardiologii

location_facility: AMH/Feasterville Family Health Care Center

location_facility: Instituto Cardiovascular De Buenos Aires

location_facility: Gabinet Lekarski Malgorzata Saryusz-Wolska

location_facility: Kocaeli University School Of Medicine-Kocaeli Universitesi Tip Fakultesi

location_facility: Debreceni Egyetem, I. sz. Belgyogyaszati Klinika

location_facility: Hospital Interzonal Gral. de Agudos Dr. Jose Penna

location_facility: Scarborough Cardiology Research Associates Inc.

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: The University of Texas Southwestern Medical Center

location_facility: Fundacion Santos y de la Garza Evia I.B.P. (Centro Medico Zambrano Hellion)

location_facility: Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.

location_facility: Miguel Sosa-Padilla, MD-Private Practice

location_facility: Doylestown Health Cardiology, a division of Doylestown Health Physicians

location_facility: Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.

location_facility: Instituto De Cardiologia Do Distrito Federal

location_facility: Centro de Investigacion Clinica del Pacifico, S.A. de C.V.

location_facility: Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS

location_facility: NZOZ "PRO CORDIS" Sopockie Centrum Badan Kardiologicznych

location_facility: CISSS des Laurentides-Point de Service de St-Jerome- Comite d'ethique de la recherche

location_facility: Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

location_facility: Suzhou Kowloon Hospital Shanghai Jiaotong University School of Medicine

location_facility: Centrum for klinisk provning-Sahlgrenska Universitetssjukhus

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Russian Cardiology Research And Production Complex of Ministry of Health of Russian Federation

location_facility: Abington Memorial Hospital (administrative only)

location_facility: Centre hospitalier de Jolimont-Lobbes - Centre de Recherche Medicale de Jolimont

location_facility: SBEI of HPE "First Pavlov State Medical University of St. Petersburg" of the MOH of the RF

location_facility: Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.

location_facility: Clinical Research Center, Phramongkutklao Hospital

location_facility: Centrul Medical Dr. Negrisanu SRL, Diabet Zaharat, Nutritie si Boli Metabolice

location_facility: Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Hoffmann-La Roche

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Peru
Guatemala
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Panama
Poland
Thailand
Norway
El Salvador
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Switzerland
Philippines
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Mexico
Czechia
Israel
Georgia
Spain

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Western General Hospital; Edinburgh Breast Unit

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Tokai University Hospital, Breast Surgery

location_facility: Burnside War Memorial Hospital, Clinical Trials Centre

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

location_facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery

location_facility: Epworth HealthCare; Clinical Trials Centre

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: Kaiser Permanente - Sacramento; Oncology Pharmacy

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Regional health authority A vitalite health network

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: YORK DISTRICT HOSPITAL; Haematology/Oncology Department

location_facility: Khechinashvili University Hospital ;Breast Unit

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: National Cancer Center; Medical Oncology

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Yeovil District Hospital; Macmillan Cancer Unit

location_facility: University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: University of Virginia Health System; Hematology/Oncology Division

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Nagoya City University Hospital; Breast Surgery

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Hyogo College Of Medicine; Breast And Endocrine Surgery

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: National Cancer Centre; Medical Oncology

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Haematology & Oncology Clinics of Australia Research Centre

location_facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: National Cancer Center Hospital; Medical Oncology

location_facility: Gunma Prefectural Cancer Center; Breast Oncology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: US oncology research at Minnesota Oncology

location_facility: Gunma University Hospital; Department of Breast and Endocrine Surgery

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Henry Ford Hospital; Hematology Oncology

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Kaiser Permanente - Walnut Creek; Oncology Pharmacy

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Institut d'oncologie de l'Orangerie; Chimiotherapie

location_facility: Universitetssjukhuset Örebro, Onkologiska kliniken

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Städtische Kliniken Frankfurt am Main Höchst

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Kaiser Permanente - Roseville; Oncology Pharmacy

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Showa University Hospital; Breast Surgery

location_facility: Hospital San Jose Del Tec. de Monterrey; Oncology

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Jichi Medical University; Breast Oncology

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Osaka International Cancer Institute; Breast and Endocrine Surgery

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Kaiser Permanente - South SF; Oncology Clinical trials

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Scientific Research Institute n.a. N.N. Petrov

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Musgrove Park Hospital; Department Clinical Research, Beacon Centre

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Florida Cancer Specialists; Saint Petersburg

location_facility: Cheltenham General Hospital; Gloucestershire Oncology Centre

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

lead_sponsor_type: industriel

status_simplified: Completed


summary: This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.

study_type: Observational

time_perspective: Retrospective

location_country:
Italy
France
Russian Federation
Australia
Spain
Turkey
Czech Republic


title: A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer

summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_country: Italy Switzerland France Romania Ireland Belgium Spain

location_facility: Institut de Cancérologie del'Ouest - site René Gauducheau

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: 'Parc Tauli Sabadell Hospital Universitari

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: AZ Groeninge Kortrijk - Campus Vercruysselaan

location_facility: Adelaide and Meath incorporating National Children's hospital department

location_facility: INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse

intervention_type: Other

status_simplified: Ongoing


type: Other Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

acronym: SPARTAN

summary: The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

ReferenceType: derived

ReferenceCitation: Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2021 Nov 19. doi: 10.1007/s12325-021-01885-6. [Epub ahead of print]

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

sequence: first

family: Oudard

full_name: Stephane Oudard

given: Stephane

sequence: additional

family: Uemura

full_name: Hiroji Uemura

given: Hiroji

family: Joniau

full_name: Steven Joniau

given: Steven

family: Dearden

full_name: Lindsay Dearden

given: Lindsay

family: Capone

full_name: Camille Capone

given: Camille

family: Van Sanden

full_name: Suzy Van Sanden

given: Suzy

family: Diels

full_name: Joris Diels

given: Joris

family: Hadaschik

full_name: Boris A. Hadaschik

given: Boris A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Advances in Therapy

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum in: BMC Urol. 2020 Oct 22;20(1):166.

family: Koroki

full_name: Yosuke Koroki

given: Yosuke

family: Iwaki

full_name: Yuki Iwaki

given: Yuki

family: Imanaka

full_name: Keiichiro Imanaka

given: Keiichiro

family: Kambara

full_name: Takeshi Kambara

given: Takeshi

family: Lopez-Gitlitz

full_name: Angela Lopez-Gitlitz

given: Angela

family: Smith

full_name: Andressa Smith

given: Andressa

full_name: Hirotsugu Uemura

given: Hirotsugu

currency_apc_doaj: GBP

evidence: oa repository (via OAI-PMH title and first author match)

ReferenceCitation: Smith MR, Mehra M, Nair S, Lawson J, Small EJ. Relationship Between Metastasis-free Survival and Overall Survival in Patients With Nonmetastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2020 Apr;18(2):e180-e189. doi: 10.1016/j.clgc.2019.10.030. Epub 2019 Nov 6.

ReferenceCitation: Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, Graff JN, McQuarrie K, Li S, Hudgens S, Lawson J, Lopez-Gitlitz A, Yu MK, Smith MR, Small EJ. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1404-1416. doi: 10.1016/S1470-2045(18)30456-X. Epub 2018 Sep 10.

ReferenceCitation: Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.

name: From the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montreal (F.S.); Guy’s, King’s and St. Thomas’ Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg–Essen and German Cancer Consortium (DKTK)–University Hospital Essen, Essen, and Ruprecht-Karls-University Heidelberg, Heidelberg — both in Germany (B.A.H.); Veterans Affairs Portland...

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Turin - Institutional Research Information System University of Turin

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Austria
Czechia
Israel
New Zealand
Spain


ReferenceCitation: Berger T, Brochet B, Brambilla L, Giacomini PS, Montalbán X, Vasco Salgado A, Su R, Bretagne A. Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. Mult Scler J Exp Transl Clin. 2019 Dec 2;5(4):2055217319887191. doi: 10.1177/2055217319887191. eCollection 2019 Oct-Dec. Erratum in: Mult Scler J Exp Transl Clin. 2020 Apr 29;6(2):2055217320921146.

name: Universitätsklinik für Neurologie, Medizinische Universität, Austria

family: Berger

full_name: T Berger

given: T

name: Groupe Hospitalier Pellegrin Hôpital Pellegrin, France

family: Brochet

full_name: B Brochet

given: B

name: IRCCS Foundation Neurological Institute Carlo Besta, Italy

family: Brambilla

full_name: L Brambilla

given: L

name: Montreal Neurological Institute & Hospital, McGill University Health Center, Canada

family: Giacomini

full_name: PS Giacomini

given: PS

name: Division of Neurology, St Michael’s Hospital, University of Toronto, Canada

name: Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Spain

family: Montalbán

full_name: X Montalbán

given: X

name: Hospital Professor Doutor Fernando Fonseca, E.P.E., Portugal

family: Vasco Salgado

full_name: A Vasco Salgado

given: A

family: Su

full_name: R Su

given: R

family: Bretagne

full_name: A Bretagne

currency_apc_doaj: USD

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Hospital Prof. Dr. Fernando Fonseca - The Institutional Repository of Hospital Prof. Dr. Fernando Fonseca

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing–remitting multiple sclerosis in a real-world clinical setting: PROTEC

lead_sponsor: Biogen

location_country: Italy Austria Spain France Czechia Slovakia Hungary Belgium Portugal Canada Slovenia

acronym: PROTEC

title: A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting

summary:
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.

The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.


title: A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML).

acronym: OPTIM-DASA

summary:
This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC).

The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.

The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.

The study will be conducted in selected FILMC and Canadian centers.

The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.

ReferenceCitation: Rousselot P, Mollica L, Guilhot J, Guerci A, Nicolini FE, Etienne G, Legros L, Charbonnier A, Coiteux V, Dartigeas C, Escoffre-Barbe M, Roy L, Cony-Makhoul P, Dubruille V, Gardembas M, Huguet F, Réa D, Cayssials E, Guilhot F, Bergeron A, Molimard M, Mahon FX, Cayuela JM, Busque L, Bouchet S. Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients. Br J Haematol. 2021 Jul;194(2):393-402. doi: 10.1111/bjh.17654. Epub 2021 Jun 30.

name: Department of Hematology and Oncology Centre Hospitalier de Versailles Le ChesnayFrance

name: UMR1184 IDMIT Department Université Paris‐Saclay Commissariat à l'énergie atomique et aux énergies alternatives University of Versailles Saint‐Quentin‐en‐Yvelines Montigny‐Le‐Bretonneux France

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

name: Department of Hematology Hôpital Maisonneuve‐Rosemont University of Montréal Montréal Québec Canada

family: Mollica

full_name: Luigina Mollica

given: Luigina

name: Inserm CIC 1402 CHU de Poitiers PoitiersFrance

family: Guilhot

full_name: Joëlle Guilhot

given: Joëlle

name: Department of Hematology CHU Brabois Vandoeuvre NancyFrance

family: Guerci

full_name: Agnès Guerci

given: Agnès

name: Department of Hematology Centre Léon Bérard LyonFrance

family: Nicolini

full_name: Franck E. Nicolini

given: Franck E.

name: Department of Hematology Institut Bergonié BordeauxFrance

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

name: Department of Hematology Hôpital Paul Brousse VillejuifFrance

family: Legros

full_name: Laurence Legros

given: Laurence

name: Department of Hematology Institut Paoli Calmette MarseilleFrance

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

name: Department of Hematology Hôpital Huriez – CHRU LilleFrance

family: Coiteux

full_name: Valérie Coiteux

given: Valérie

name: Department of Hematology CHU de Tours ToursFrance

family: Dartigeas

full_name: Caroline Dartigeas

given: Caroline

name: Department of Hematology Centre Hospitalier Pontchaillou RennesFrance

family: Escoffre‐Barbe

full_name: Martine Escoffre‐Barbe

given: Martine

name: Department of Hematology Hôpital Henri Mondor AP‐HP CréteilFrance

family: Roy

full_name: Lydia Roy

given: Lydia

name: Department of Hematology Centre Hospitalier Annecy Genevois PringyFrance

family: Cony-Makhoul

full_name: Pascale Cony-Makhoul

given: Pascale

name: Department of Hematology Hôpital Hôtel‐Dieu CHU de Nantes NantesFrance

family: Dubruille

full_name: Viviane Dubruille

given: Viviane

name: Department of Hematology CHU d’Angers AngersFrance

family: Gardembas

full_name: Martine Gardembas

name: Department of Hematology Institut Universitaire du Cancer – Oncopole ToulouseFrance

family: Huguet

full_name: Françoise Huguet

given: Françoise

name: Department of Hematology Hôpital Saint‐Louis et EA3518 AP‐HP ParisFrance

family: Réa

full_name: Delphine Réa

given: Delphine

name: Department of Hematology CHU de Poitiers PoitiersFrance

family: Cayssials

full_name: Emilie Cayssials

given: Emilie

full_name: François Guilhot

given: François

name: Department of Pneumology Hôpital Saint‐Louis AP‐HP ParisFrance

family: Bergeron

full_name: Anne Bergeron

given: Anne

name: Clinical Pharmacology Department Centre Hospitalier Pellegrin CHU de Bordeaux BordeauxFrance

name: University of Bordeaux Ségalen BordeauxFrance

family: Molimard

full_name: Mathieu Molimard

given: Mathieu

family: Mahon

full_name: Francois-Xavier Mahon

given: Francois-Xavier

name: Hematology and Molecular Biology and EA3518 Hôpital Saint‐Louis AP‐HP Paris France

family: Cayuela

full_name: Jean-Michel Cayuela

given: Jean-Michel

location_facility: Queen elisabeth II Health Sciences Center

location_facility: Hôpital Général Juif - Sir. Mortimer B. Davis

location_facility: Hôpital de l'Enfant Jésus - Centre hospitalier affilié universitaire de Québec

location_facility: Pavillon Hôtel-Dieu de Québec - Centre hospitalier universitaire de Québec

location_facility: Southern Alberta Cancer Research Institute


ReferenceCitation: Gogas H, Dummer R, Ascierto PA, Arance A, Mandalà M, Liszkay G, Garbe C, Schadendorf D, Krajsová I, Gutzmer R, Sileni VC, Dutriaux C, Yamazaki N, Loquai C, Queirolo P, Jan de Willem G, Sellier AT, Suissa J, Murris J, Gollerkeri A, Robert C, Flaherty KT. Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS). Eur J Cancer. 2021 Jul;152:116-128. doi: 10.1016/j.ejca.2021.04.028. Epub 2021 Jun 4. Erratum in: Eur J Cancer. 2021 Oct 27;:.

family: Gogas

full_name: Helen Gogas

given: Helen

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Arance

full_name: Ana Arance

given: Ana

family: Mandalà

full_name: Mario Mandalà

given: Mario

family: Liszkay

full_name: Gabriella Liszkay

given: Gabriella

family: Garbe

full_name: Claus Garbe

given: Claus

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Krajsová

full_name: Ivana Krajsová

given: Ivana

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Sileni

full_name: Vanna Chiarion Sileni

given: Vanna Chiarion

family: Dutriaux

full_name: Caroline Dutriaux

family: Yamazaki

full_name: Naoya Yamazaki

given: Naoya

family: Loquai

full_name: Carmen Loquai

given: Carmen

family: Queirolo

full_name: Paola Queirolo

given: Paola

family: Jan de Willem

full_name: Groot Jan de Willem

given: Groot

family: Sellier

full_name: Abir Tadmouri Sellier

given: Abir Tadmouri

family: Suissa

full_name: Jeanne Suissa

given: Jeanne

family: Murris

full_name: Juliette Murris

given: Juliette

family: Gollerkeri

full_name: Ashwin Gollerkeri

given: Ashwin

family: Robert

full_name: Caroline Robert

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gogas HJ, Flaherty KT, Dummer R, Ascierto PA, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Sileni VC, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Gollerkeri A, Pickard MD, Robert C. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management. Eur J Cancer. 2019 Sep;119:97-106. doi: 10.1016/j.ejca.2019.07.016. Epub 2019 Aug 19.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Dummer R, Ascierto PA, Gogas HJ, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Chiarion Sileni V, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Moutouh-de Parseval LA, Pickard MD, Sandor V, Robert C, Flaherty KT. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1315-1327. doi: 10.1016/S1470-2045(18)30497-2. Epub 2018 Sep 12. Erratum in: Lancet Oncol. 2018 Oct;19(10):e509.

ReferenceCitation: Dummer R, Ascierto PA, Gogas HJ, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Chiarion-Sileni V, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Moutouh-de Parseval LA, Pickard MD, Sandor V, Robert C, Flaherty KT. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):603-615. doi: 10.1016/S1470-2045(18)30142-6. Epub 2018 Mar 21.

title: Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF -mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Greece
Australia
Russian Federation
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Switzerland
Netherlands
Singapore
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Fachklinik Hornheide Abteilung für Internistische Onkologie und Hämatologie

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Institut für Diagnostische und Interventionelle Radilogie

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Überörtliche Radiologische Gemeinschaftspraxis Dresden

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Universitätsklinik für Radiologie und Nuklearmedizin

location_facility: Institut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Azienza Ospedaliera Universitaria Senese

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Radboud University Nijmegen Medical Centre

location_facility: University of Illinois Hospital and Health Sciences System - Investigational Drug Service

location_facility: Instituto Nacional de Cardiología Ignacio Chavez

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Centre Hospitalier De L'Universite De Montreal Hospital Notre Dame

location_facility: Sir Charles Gairdner Hospital Pharmacy Department

location_facility: Investigational Drug Service, Department of Pharmacy (Investigational Product)

location_facility: Hôpital D'Instruction des Armées Desgenettes

location_facility: Klinik und Poliklinik für Augenheilkunde

location_facility: Oslo universitetssykehus HF, Utprøvingsenheten

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Erasmus MC-Daniel den Hoed Oncologisch Centrum

location_facility: Northern Virginia Ophthalmology Associates

location_facility: Universitätsklinikum Freiburg, Klinik für Radiologie

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Lack's Cancer Center at Mercy Health Saint Mary's

location_facility: Virginia Cancer Specialists (Leesburg) - USOR

location_facility: Medica Sur, S. A. B de C. V. (Centro de Investigación Farmacológica y Biotecnológica CIF-BIOTEC)

location_facility: University of Rochester Medical Center - PPDS

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Institut für diagnostische und interventionelle Radiologie

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Internistische Schwerpunktpraxis Kardiologie Hämatologie Onkologie

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hygeia Diagnostic and Therapeutic Centre of Athens

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Mercy Health Hauenstein Neuroscience Center Neuro-Ophthalmology (Clinic)

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Universitario Virgen De La Arrixaca

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Civile Maria Paternò Arezzo Ragusa

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Sifa Universitesi Bornova Egitim Arastirma Hastanesi

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Regional Universitario de Malaga ? Hospital General

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Institut für Diagnostische und Interventionelle Radiologie

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: IRCCS Giovanni Paolo II Cancer Institute

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: Diagnostische und interventionelle Radiologie und Neuroradiologie

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: Istituto Clinico Humanitas - Humanitas Cancer Center

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

title: A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

summary:
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
LGX818 300 mg QD monotherapy (denoted as LGX818 arm)