title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome

acronym: AEGIS-II

summary: This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

primary_purpose: Prevention

lead_sponsor: CSL Behring

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Georgia
Estonia
Latvia
Finland
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: 2080019 - Sjaellands Universitetshospital - Kardiologisk Afdeling

location_facility: 3000026 - University General Hospital Attikon

location_facility: 8401164 - University of Toledo Medical Center

location_facility: 8400504 - Integris Baptist Medical Center

location_facility: 8401000 - Advocate Lutheran General Hospital

location_facility: 8040037 - The Ivano-Frankivsk National Medical Univeristy

location_facility: 1520014 - Hospital Clinico Regional Dr. Guillermo Grant Benavente

location_facility: 8400320 - Black Hills Cardiovascular Research

location_facility: 1000054 - Multiprofile Hospital for Active Treatment "National Cardiac Hospital"

location_facility: 6430049 - Pokrovskaya Municipal Hospital

location_facility: 1000029 - Multiprofile Hospital for Active Treatment AD Haskovo

location_facility: 4840006 - Centro para el Desarrollo de la Medicina y de Asistencia Méd

location_facility: 4840022 - Centro de Atencion e Investigacion Cardiovascular del Potosi

location_facility: 2030073 - Karlovarska Krajska Nemocnice a.s.

location_facility: 8400576 - IU Health Ball Memorial Hospital Physicians, Inc

location_facility: 7920017 - Eskişehir Osmangazi Üniversitesi Tıp Fakültesi

location_facility: 6200021 - Centro Hospitalar do Alto Ave, EPE

location_facility: 7920018 - Cukurova University School Of Medicine Balcali Hospital

location_facility: 8260099 - The Royal Wolverhampton NHS Trust - New Cross Hospital

location_facility: 5780003 - Akershus Universitetssykehus HF

location_facility: 2030061 - Oblastní nemocnice Náchod, a.s

location_facility: 3000016 - General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: 3480020 - Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: 6430092 - Yaroslavl Regional Clinical Hospital

location_facility: 8400746 - Penn Presbyterian Medical Center

location_facility: 1910003 - Klinicki Bolnicki Centar Zagreb

location_facility: 4100016 - Veterans Health Service Medical Center

location_facility: 6420059 - Institutul de Urgenta pentru Boli Cardiovasculare si Transplant

location_facility: 6430047 - Novosibirsk Regional Clinical Hospital

location_facility: 8400622 - Mercy Medical Research Institute

location_facility: 0400031 - Universitatsklinik fuer Innere Medizin II, Kardiol

location_facility: 2030059 - Uherskohradišťská nemocnice a.s.

location_facility: 6880019 - KBC "Dr Dragiša Mišović-Dedinje"

location_facility: 8040008 - Kyiv City Clinical Hospital No. 1

location_facility: 8040009 - Kiev City Clinical Hospital No. 5

location_facility: 8400997 - CardioVascular Institute of North Colorado Cardiology Clinic

location_facility: 8400551 - Cardiovascular Research of Knoxville

location_facility: 0760039 - Hospital Evangelico de Vila Velha (HEVV)

location_facility: 3480022 - University of Szeged - Second Department of Medicine & Cardiology Centre

location_facility: 7240077 - Hospital Universitari Arnau de Vilanova de Lleida

location_facility: 2080020 - Hjertesygdomme | Regionshospitalerne i Viborg og Skive

location_facility: 1000044 - Second Multiprofile Hospital for Active Treatment - Sofia EA

location_facility: 7920022 - Marmara Universitesi Tip Fakultesi

location_facility: 3000025 - University General Hospital of Patras

location_facility: 1000043 - Multiprofile Hospital for Active Treatment Blagoevgrad AD

location_facility: 6160066 - IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angio

location_facility: 8400684 - UCHealth Memorial Hospital Central - Colorado Springs

location_facility: 6160078 - Nowy Szpital Uniwersytecki w Krakowie-Prokocimiu

location_facility: 3000023 - National and Kapodistrian University of Athens (NKUA) - Scho

location_facility: 6420051 - Institutul Inimii "Niculae Stancioiu"

location_facility: 6420088 - Institutul Inimii "Niculae Stancioiu"

location_facility: 2460006 - Helsinki University Central Hospital (HUCH)

location_facility: 6160077 - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach

location_facility: 8401175 - Overton Brooks V.A. Medical Center

location_facility: 7020006 - National Heart Center Singapore

location_facility: 0320040 - Instituto de Cardiología de Corrientes

location_facility: 5280031 - Meander Medisch Centrum - Locatie Amersfoort

location_facility: 1240093 - Halton Healthcare - Oakville Trafalgar Memorial Hospital

location_facility: 8400485 - V.A. North Texas Health Care System

location_facility: 4840004 - Hospital Cardiológica Aguascal

location_facility: 7920026 - Ondokuz Mayis Üniversitesi - Kardiyoloji Anabilim Dalı

location_facility: 6160086 - Dept. of Interventional cardiology and Angiology, Institute

location_facility: 8400661 - Norton Cardiovascular Associates

location_facility: 8400735 - Parkway Cardiology Associates, PC

location_facility: 2330005 - North Estonia Medical Centre Foundation

location_facility: 3480040 - Jahn Ferenc Dél-pesti Kórház és Rendelőintézet

location_facility: 0560022 - Centre Hospitalier Universitaire de Tivoli

location_facility: 0760081 - Hospital Universitário Cassiano Antonio Moraes (HUCAM)

location_facility: 7240030 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: 3760029 - Hadassah Medical Center-Mount Scopus

location_facility: 3920093 - Miyazaki Medical Association Hospital

location_facility: 4840045 - OCA Hospital - Monterrey International Research Center

location_facility: 8260043 - University Hospitals of Leicester NHS Trust - Glenfield

location_facility: 2500105 - CHU de Nimes - Hopital Universitaire Caremeau

location_facility: 5280042 - Elisabeth TweeSteden Ziekenhuis Vestiging Tilburg

location_facility: 0760085 - Hospital Universitário São José (HUSJ)

location_facility: 7240047 - Parc Taulí Sabadell Hospital Universitari

location_facility: 8260057 - Mid Essex Hospital Services NHS Trust - Broomfield Hospital

location_facility: 0320032 - Hospital Dr. Jose Maria Cullen

location_facility: 3800170 - Fondazione Poliambulanza Istituto Ospedaliero

location_facility: 8401233 - Cincinnati V.A. Medical Center

location_facility: 1000058 - Multiprofile Hospital for Active Treatment Plovdiv AD

location_facility: 8260093 - The London North West Healthcare NHS Trust - Northwick Park

location_facility: 8400688 - George Washington University Medical Center

location_facility: 6420049 - Spitalul Clinic Judetean de Urgenta Tîrgu - Mures

location_facility: 2760193 - CardioVaskulares Centrum Frankfurt

location_facility: 2760157 - SRH Klinikum Karlsbad-Langensteinbach GmbH

location_facility: 6160080 - Regional Public Specialty Hospital "Latawiec"

location_facility: 0400034 - Klinikum Klagenfurt am Wörthersee

location_facility: 0320071 - Hospital Provincial del Centenario

location_facility: 1580008 - Mackay Memorial Hospital - Tamsui Branch

location_facility: 4580002 - Hospital Umum Sarawak (HUS) - The Cardiac Centre

location_facility: 8400747 - Phoenix V.A. Health Care System

location_facility: 7640010 - King Chulalongkorn Memorial Hospital

location_facility: 7240068 - Hospital Universitario Marqués de Valdecilla

location_facility: 8400700 - Mercy Saint Vincent Medical Center

location_facility: 5280048 - Amphia Zienkenhuis - Locatie Molengracht Breda

location_facility: 1240066 - Centre Integre Universitaire de la Mauricie-et-du-Centre-du-Quebec

location_facility: 2760168 - Klinikum Frankfurt Höchst GmbH

location_facility: 1240107 - Clinique de Cardiologie de Levis

location_facility: 1000033 - University Multiprofile Hospital for Active Treatment

location_facility: 7920032 - Kocaeli Universitesi Tip Fakultesi - Kardiyoloji Anabilim Dalı Başkanı

location_facility: 4100021 - Chungbuk National University Hospital

location_facility: 8400975 - Central Arkansas Veterans Healthcare System

location_facility: 4580008 - Universiti Kebangsaan Malaysia Medical Centre

location_facility: 4840008 - Hospital Civil de Guadalajara - Nuevo Hospital Civil de Guadalajara

location_facility: 6160096 - 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

location_facility: 6420047 - Spitalul de Urgenta "Sf. Ioan Cel Nou" Suceava

location_facility: 7030006 - Univerzitna Nemocnica Bratislava - Nemocnica Staré Mesto

location_facility: 8040023 - Zhitomir Regional Clinical Hospital

location_facility: 2500092 - Centre Hospitalier Régional Metz-Thionville

location_facility: 8260134 - The Newcastle upon Tyne Hospitals NHS Foundation Trust - Fre

location_facility: 4840018 - Centro de Alta Especialidad Dr. Rafael Lucio

location_facility: 7920024 - Afyon Kocatepe University Medical Faculty Dept. Of Cardiology

location_facility: 1240083 - CHU de Quebec-Universite-Laval, HDQ

location_facility: 7240046 - Parc Taulí Sabadell Hospital Universitari

location_facility: 8401157 - Memorial Health University Medical Center

location_facility: 0560046 - AZ Groeninge - Campus Kennedylaan

location_facility: 3800129 - Azienda Ospedaliero-Universitaria Careggi

location_facility: 0760012 - Instituto de Cardiologia do Rio Grande do Sul

location_facility: 8400693 - University of California Los Angeles

location_facility: 3920115 - Matsusaka Chuo General Hospital

location_facility: 8400577 - Doylestown Cardiology Associates

location_facility: 3440004 - Queen Elizabeth Hospital (QEH)

location_facility: 0760036 - Hospital Geral Universitário de Cuiabá - HGU

location_facility: 0560023 - Centre Hospitalier Universitaire Brugmann

location_facility: 8400610 - Jesse Brown V.A. Medical Center

location_facility: 2500081 - CHU Besançon - Hôpital Jean Minjoz

location_facility: 3920111 - Ishikawa Prefectural Central Hospital

location_facility: 3480029 - Békés Megyei Pándy Kálmán Kórház

location_facility: 6160065 - III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokard

location_facility: 6430067 - Saratov State Medical University named after V.I. Razumovsky

location_facility: 2030031 - Nemocnice Jablonec nad Nisou, p.o.

location_facility: 6430110 - SBHI of Novosibirsk Region "City Clinical Hospital of Emergency Care #2"

location_facility: 4400006 - Public Institution Republican Panevezys Hospital

location_facility: 3920099 - Yokohama City University Medical Center

location_facility: 2030041 - Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice

location_facility: 7100010 - Clinical Projects Research SA (Pty) Ltd.

location_facility: 8260071 - Ashford and St Peter's Hospitals NHS Foundation Trust

location_facility: 1240062 - Saint Boniface General Hospital

location_facility: 6200018 - Centro Hospitalar e Universitário de Coimbra, EPE - Hospitai

location_facility: 1240092 - CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: 7240045 - Hospital Universitario Ramón y Cajal

location_facility: 0320069 - Hospital Italiano Regional del Sur

location_facility: 6420071 - Institutului de Boli Cardiovasculare Timişoara

location_facility: 0760034 - Hospital e Maternidade Celso Pierro

location_facility: 2680022 - Bokhua Memorial Cardiovascular Center

location_facility: 1240099 - Centre Hospital Saint Georges de Beauce

location_facility: 4840003 - Centro de Estudios Clínicos de Querétaro, SC

location_facility: 1580002 - Kaohsiung Veterans General Hospital

location_facility: 7920031 - Konya Necmettin Erbakan University Meram Medical Faculty - D

location_facility: 2760111 - Klinikum der Stadt Ludwigshafen gGmbH

location_facility: 8400334 - Cardiology Associates of North Mississippi

location_facility: 1910013 - Klinički bolnički centar Sestre milosrdnice

location_facility: 4100008 - Seoul National University Hospital

location_facility: 6420050 - Spitalul Universitar de Urgent

location_facility: 6200025 - Unidade Local de Saude de Matosinhos - Hospital Pedro Hispan

location_facility: 6200026 - Centro Hospitalar do Baixo Vouga

location_facility: 3000029 - University of Thessaly- General University Hospital of Laris

location_facility: 8040048 - Communal Institution of Healthcare "Kharkiv Municipal Clinic

location_facility: 3800106 - Università degli Studi di Roma "La Sapienza"

location_facility: 8400507 - The Saint Vincent Heart Center of Indiana

location_facility: 8401128 - Hillcrest Family Health Center

location_facility: 4100017 - Chungnam National University Hospital

location_facility: 6420044 - Spitalul Clinic Judetean de Ur

location_facility: 8400626 - Montefiore Medical Center - Albert Einstein College of Medicine

location_facility: 8401141 - Western Michigan University Homer Striker MD School of Medicine

location_facility: 6160061 - Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

location_facility: 3000008 - University of Ioannina School of Medicine - Michaelidion Cardiac Center

location_facility: 8400713 - University of South Alabama College of Medicine

location_facility: 8400361 - Midwest Cardiovascular Research

location_facility: 3920119 - Ehime Prefectural Central Hospital

location_facility: 6420045 - Spitalul Clinic Judeţean de Urgenţă Oradea

location_facility: 3800090 - Gruppo Ospedaliero San Donato - Policlinico San Marco

location_facility: 8401108 - University of Missouri Health System

location_facility: 8401120 - Northeast Georgia Medical Center

location_facility: 4840077 - Unidad de Investigacion en Salud (UIS)

location_facility: 7240053 - Hospital Universitari de Bellvitge (IDIBELL)

location_facility: 6160095 - Centrum Kardiologii Inwazyjnej i Angiologii w Krośnie

location_facility: 8040012 - Kharkiv City Clinical Hospital #8

location_facility: 8400625 - Michigan Heart and Vascular Institute

location_facility: 1000038 - Acibadem City Clinic University Hospital, EOOD

location_facility: 8401010 - Integrative Research Associates Inc.

location_facility: 8401127 - Tulane University Health Science Center

location_facility: 0320033 - Corporacion Medica de San Martin

location_facility: 2760167 - Ev. und Johanniter Klinikum Niederrhein, Kardiologie

location_facility: 3480025 - Dombovari Szent Lukacs Egeszsegugyi Kft

location_facility: 1580010 - China Medical University Hospital

location_facility: 0760077 - Instituto de Pesquisa Clinica de Campinas

location_facility: 3920116 - Nihon University Itabashi Hospital

location_facility: 4840020 - Centro de Estudios de Alta Especialidad de Sinaloa, S.C.

location_facility: 3760026 - The Baruch Padeh Medical Center

location_facility: 3480028 - Magyar Honvédség Egészségügyi Központ

location_facility: 2030052 - Všeobecná fakultní nemocnice v Praze

location_facility: 3800123 - AORN - Ospedali dei Colli Ospedale V. Monaldi

location_facility: 6160051 - Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: 0760009 - Santa Casa de Misericordia de Marilia

location_facility: 8260066 - Torbay and South Devon NHS Foundation Trust - Torbay Hospital

location_facility: 3480045 - Somogy Megyei Kaposi Mór Oktató Kórház

location_facility: 1240090 - New Brunswick Heart Centre Research Initiative

location_facility: 3000013 - University General Hospital of Thessaloniki AHEPA

location_facility: 4580016 - University Malaya Medical Centre

location_facility: 6430079 - Scientific-Research Institute of Complex Problems of Cardio

location_facility: 5280038 - Admiraal de Ruijter Ziekenhuis - Locatie Goes

location_facility: 2760139 - Staedtisches Klinikum Dresden-Friedrichstadt - I. Medizinisc

location_facility: 3000024 - University Hospital of Alexandroupolis

location_facility: 2680027 - Tbilisi State Medical University (TSMU) - S. Khechinashvili

location_facility: 4100022 - Hallym University Sacred Heart Hospital

location_facility: 4400004 - Hospital of Lithuanian University of Health Sciences - Kauno Klinikos

location_facility: 3920106 - Hyogo Prefectural Amagasaki General Medical Center

location_facility: 6160062 - Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Op

location_facility: 8400863 - Swedish Medical Center - Providence Campus

location_facility: 1240059 - Centre Hospitalier Pierre-Le Gardeur

location_facility: 8260102 - Queen Elizabeth Hospital Birmingham

location_facility: 3480019 - Debreceni Egyetem Klinikai Központ

location_facility: 3800087 - Azienda Ospedaliera Universitaria "Federico II"

location_facility: 7920029 - Cumhuriyet Universitesi Tip Fakultesi - Kardiyoloji Anabilim

location_facility: 2500162 - CHRU de Tours - Hopital Trousseau

location_facility: 2500120 - Centre Hospitalier Annecy Genevois

location_facility: 1240106 - McGill University Health Centre (MUHC)

location_facility: 8400572 - AtlantiCare Regional Medical Center

location_facility: 8400921 - Mission Research Institute, LLC

location_facility: 6420083 - Institutului de Boli Cardiovasculare Timişoara

location_facility: 1240078 - Kawartha Cardiology Clinical Trials

location_facility: 7920012 - Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

location_facility: 6880009 - Department of Cardiology, Clinical Center of Serbia and Belgrade

location_facility: 7240050 - Hospital de la Santa Creu i Sant Pau

location_facility: 2030040 - Oblastní Nemocnice Kladno, a.s.

location_facility: 8400543 - Cardiology Partners Research Institute

location_facility: 6430091 - City clinical hospital #15 n.a. O.M. Filatov

location_facility: 8400364 - Minneapolis Heart Institute Foundation

location_facility: 4100010 - The Catholic University of Korea, St. Vincent's Hospital

location_facility: 6430064 - City Hospital for Emergency Care of Rostov-on-Don

location_facility: 6420048 - Spitalul Judetean de Urgenta Pitesti-Arges

location_facility: 0320073 - Instituto Medico De Alta Complejidad - IMAC

location_facility: 0320017 - Entidades Vinculadas al Sanatorio Parque

location_facility: 3800107 - Università degli Studi "Magna Graecia" di Catanzaro

location_facility: 0320041 - Clinica y Maternidad Suizo Argentina (CyMSA)

location_facility: 6040025 - Hospital Alberto Sabogal Sologuren

location_facility: 6430115 - Pavlov First Saint Petersburg State Medical University

location_facility: 0560024 - Onze-Lieve-Vrouwziekenhuis VZW (OLV)

location_facility: 8040035 - Lviv Regional State Clinical-and-Diagnostic Cardiology Cente

location_facility: 0320021 - Sanatorio Medico de Diagnostico y Tratamiento S.A.

location_facility: 7920025 - Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi - Kardiyo

location_facility: 8040017 - National Institute of Therapy named after L.T. Malaya NAMS o

location_facility: 8400517 - Shands Jacksonville Medical Center

location_facility: 8260101 - United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital

location_facility: 3000007 - General Hospital of Nikea "Agios Panteleimon"

location_facility: 8400812 - Maine Medical Center Bramhall Campus

location_facility: 8400484 - Clearwater Cardiovascular and Interventional Consultants

location_facility: 1910024 - Klinički Bolnički Centar Split

location_facility: 2760146 - Innere Medizin I, Marienhaus Klinikum Eifel Bitburg

location_facility: 8260086 - Manchester University NHS Foundation Trust - Manchester Royal Infirmary

location_facility: 2680026 - Georgian-Dutch Hospital MEDISON

location_facility: 8400502 - Stroobants Cardiovascular Center

location_facility: 6880008 - Clinical Center of Serbia -- Division of Cardiology

location_facility: 0760053 - Fundação Bahiana de Cardiologia

location_facility: 8400596 - Long Beach Memorial Medical Center

location_facility: 6430068 - Regional Budgetary Healthcare Institution "Cardiology Dispensary"

location_facility: 8400557 - Clearwater Cardiovascular and Interventional Consultants

location_facility: 8400961 - Indiana Heart Physicians, Inc.

location_facility: 0760016 - Faculdade de Medicina de Sao Jose do Rio Preto-SP - Hospital

location_facility: 1580009 - National Taiwan University Hospital

location_facility: 2030057 - Fakultní Nemocnice Hradec Králové

location_facility: 1580004 - Shin Kong Wu Ho-Su Memorial Hospital

location_facility: 6430075 - First City Clinical Hospital named after E. E. Volosevich

location_facility: 0760069 - Hospital Universitario Evangelico de Curitiba

location_facility: 8400667 - Michigan Cardiovascular Institute

location_facility: 2030071 - Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha

location_facility: 0320013 - Hospital Municipal de Coronel Suárez

location_facility: 2760186 - Katholisches Klinikum Mainz - Klinik fuer Innere Medizin I

location_facility: 3760037 - Tel Aviv University Sackler School of Medicine - Meir Medica

location_facility: 3920128 - Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: 1000053 - Multiprofile Hospital For Active Treatment - Pazardzhik AD

location_facility: 3480035 - Tolna Megyei Balassa Janos Korhaz

location_facility: 8401189 - Cardiovascular Associates of the Delaware Valley

location_facility: 6160063 - Klinika Kardiologii i Kardiochirurgii 10 WSK

location_facility: 6430074 - St. Petersburg State Institution of Healthcare

location_facility: 3760038 - Tel Aviv Sourasky Medical Center

location_facility: 6160100 - Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

location_facility: 7920016 - Ankara Sehir Hastanesi Bilkent

location_facility: 8040021 - Heart Institute of the Ministry of Health of Ukraine

location_facility: 8400379 - John Muir Health and Cardiovascular Institute

location_facility: 6880023 - Kliničko Bolnički Centar Zvezdara

location_facility: 1000071 - University Multiprofile Hospital for Active Treatment "Dr. G"

location_facility: 2080016 - Medicinsk Afdeling - Herning Sygehus

location_facility: 0560020 - AZ Sint-Jan Brugge-Oostende AV

location_facility: 2500080 - CHU de Toulouse - Hopital Rangueil - Cardiologie

location_facility: 2760140 - Cardiologicum Hamburg - Studienzentrum

location_facility: 0320037 - Centro Privado de Cardiologia (CPC)

location_facility: 0760057 - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza

location_facility: 1240071 - Institut universitaire de cardiologie et de pneumologie de Quebec

location_facility: 7240035 - Complexo Hospitalario Universitario A Coruña

location_facility: 7240054 - Hospital Universitari Son Espases

location_facility: 7920021 - Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: 0320029 - Instituto Cardiovascular de Buenos Aires

location_facility: 3000010 - University Hospital of Ioannina

location_facility: 1700018 - Caja de Compensacion Familiar de Caldas

location_facility: 2030020 - Fakultní nemocnice Královské Vinohrady

location_facility: 4400005 - Vilnius University Hospital Santaros Klinikos

location_facility: 8400854 - The Chattanooga Heart Institute

location_facility: 2500107 - Centre Hospitalier Sud Francilien

location_facility: 3800085 - Azienda Socio-Sanitaria Territoriale della Valle Olona

location_facility: 1000056 - Acibadem City Clinic Tokuda Hospital, EAD

location_facility: 4100015 - Pusan National University Yangsan Hospital

location_facility: 1580001 - Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: 6420090 - Spitalul Clinic de Urgenţă "Bagdasar-Arseni"

location_facility: 8400910 - Cardiovascular Innovation and Research Center

location_facility: 8400751 - Providence Everett Medical Center

location_facility: 2680012 - Chapidze Emergency Cardiology Center

location_facility: 5280060 - Ziekenhuis Rivierenland - Cardiologie

location_facility: 8040010 - Dnipropetrovsk Medical Academy, Dnipropetrovsk Joint Emergen

location_facility: 0760037 - Hospital de Messejana Dr. Carlos Alberto Gomes Studart

location_facility: 1700012 - Fundación Oftalmológica de Santander - Clinica FOSCAL

location_facility: 8040036 - Regional Medical Center for Cardiovascular Diseases

location_facility: 8400890 - Revival Research Institute, LLC

location_facility: 1700017 - Fundación Cardiovascular de Colombia

location_facility: 2500042 - CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: 3920094 - Juntendo University Shizuoka Hospital

location_facility: 1000045 - MHAT City Clinic - Sv. Georgi EOOD

location_facility: 3480033 - Semmelweis University, Faculty of Medicine

location_facility: 4100014 - Yonsei University, Wonju Severance Christian Hospital

location_facility: 3920123 - Tokyo Women's Medical University Hospital

location_facility: 6040031 - Clínica Internacional - Sede San Borja

location_facility: 4580005 - Universiti Teknologi MARA (UiTM)

location_facility: 8400891 - John Muir Medical Center Walnu

location_facility: 6160082 - II Oddział Kardiologiczny PAKS

location_facility: 6430042 - Research Institute of Cardiology

location_facility: 7920015 - T.C. Saglik Bakanligi - Kartal Kosuyolu Yuksek Ihtisas Egitim

location_facility: 8401192 - South Orange County Surgical Medical Group

location_facility: 2680004 - Clinical Cardology Institute Ltd.

location_facility: 8400677 - Saint Joseph's Hospital Cardiac Catheterization Associates

location_facility: 4840033 - Virgen Cardiovascular Research S.C.

location_facility: 7240063 - Hospital Universitario Vall d'Hebron

location_facility: 1240061 - SMH Cardiology Clinical Trials Inc.

location_facility: 3800081 - Azienda Ospedaliera Universitaria "Federico II"

location_facility: 0760055 - Instituto Cardio Pulmonar da Bahia - Hospital

location_facility: 8040013 - Khmelnytskyi Regional Hospital

location_facility: 6880013 - General Hospital Sremska Mitrovica

location_facility: 4840014 - Investigacion Biomedica para el Desarrollo de Farmacos S.A d

location_facility: 6200014 - Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Santa

location_facility: 1910019 - Klinicki Bolnicki Centar Rijeka - Susak

location_facility: 3480018 - Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintéz

location_facility: 2760147 - GPR Klinikum Rüsselsheim II - Medizinische Klinik Innere Medizin

location_facility: 5280056 - Groene Hart Ziekenhuis - Gouda

location_facility: 2080015 - Koege Sygehus - University Hospital Sjaelland

location_facility: 0760061 - Hospital Universitario Maria Aparecida Pedrossian

location_facility: 2680013 - Tbilisi Heart and Vascular Clinic LTD

location_facility: 2760130 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: 3920114 - Toho University Ohashi Medical Center

location_facility: 7520011 - Karolinska Universitetssjukhuset - Huddinge

location_facility: 8400369 - HealthEast Saint Joseph's Hospital

location_facility: 8400718 - V.A. Pittsburgh Healthcare System

location_facility: 4840021 - Universidad Autonoma de Nuevo Leon - Hospital Universitario

location_facility: 1000070 - University Multiprofile Hospital for Active Treatment Alexa

location_facility: 1000057 - Specialized Hospital for Active Treatment in Cardiology EAD

location_facility: 7020005 - National University Hospital (S) Pte Ltd

location_facility: 7920023 - Ege Üniversitesi Tıp Fakültesi

location_facility: 6200022 - Centro Hospitalar e Universitário de Coimbra, EPE - Hospital

location_facility: 2680002 - Helsicore - Israeli Georgian Medical Research Clinic

location_facility: 8040016 - Lviv National Medical University named by Danylo Halitskyy

location_facility: 3800110 - Fondazione IRCCS Policlinico San Matteo

location_facility: 8401027 - UNC Hospitals Heart and Vascular Center at Meadowmont

location_facility: 8400322 - Wake Forest University Health Sciences, Dept. of Cardiovascular Medicine

location_facility: 7030014 - Univerzitna Nemocnica Bratislava - Nemocnica sv. Cyrila a Me

location_facility: 1240081 - Saint Jerome Medical Research, Inc.

location_facility: 6430063 - Lyubertsy Regional Hospital No. 2

location_facility: 7240064 - Hospital General Universitario de Alicante

location_facility: 1000035 - "MHAT "Sveta Anna"" - Sofia AD

location_facility: 2080014 - Svendborg Sygehus, Ward "Forskningsenheden Afd M Svendborg"

location_facility: 3920133 - Kanagawa Cardiovascular and Respiratory Center

location_facility: 5280058 - Universitair Medisch Centrum Utrecht

location_facility: 8401103 - Orange Coast Memorial Hospital

location_facility: 1240063 - Heritage Medical Research Clinic

location_facility: 4280008 - Pauls Stradins Clinical University Hospital

location_facility: 8400574 - Aurora Denver Cardiology Associates

location_facility: 8401104 - Cardiovascular Institute of the South

location_facility: 2680018 - TSMU - Alexandre Aladashvili University Clinic

location_facility: 6420053 - Spitalul Clinic Judetean de Urgenta Brasov

location_facility: 8400779 - MedStar Clinical Research Center

location_facility: 8400563 - Cardiovascular Institute of the South

location_facility: 0320027 - Estudios Clínicos de los Arroyos

location_facility: 6160093 - Specjalistyczny Szpital im. dr Alfreda Sokolowskiego

location_facility: 8040050 - Regional Clinical Hospital - Emergency Medical Care

location_facility: 2680015 - Chapidze Emergency Cardiology Center

location_facility: 6040056 - Instituto Nacional Cardiovascular - INCOR

location_facility: 2500112 - Centre Hospitalier Régional Universitaire de Lille (CHRU)

location_facility: 8400998 - Beth Israel Deaconess Medical Center

location_facility: 1910008 - Specijalna Bolnica za Medicinsku Rehabilitaciju Krapinske Toplice

location_facility: 6880012 - Institute of Cardiovascular Diseases of Vojvodina

location_facility: 8400904 - Northeast Iowa Medical Education Foundation

location_facility: 2760106 - Universitätsklinikum Hamburg-Eppendorf (UKE)

location_facility: 8040032 - Ivano-Frankivskyy oblasnyy klinichnyy kardiologichnyy dyspan

location_facility: 3800075 - ASST degli Spedali Civili di Brescia

location_facility: 3800082 - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: 4840074 - Unidad de Investigación y Salud de Puebla S.C.

location_facility: 5280063 - Zuyderland Medisch Centrum, Heerlen

location_facility: 8400916 - Southeastern Cardiology & Cardiovascular Clinic

location_facility: 8400719 - V.A. San Diego Health Care System

location_facility: 6200017 - Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE - Hospital

location_facility: 8260088 - Kettering General Hospital NHS Foundation Trust

location_facility: 6420043 - Spitalul Universitar de Urgenta Bucuresti

location_facility: 8400862 - Cardiovascular Associates Research

location_facility: 2760190 - Asklepios Kliniken Hamburg GmbH

location_facility: 4100025 - Korea University Anam Hospital

location_facility: 6430116 - City hospital # 2 "Sosnovaya roscha"

location_facility: 8400847 - University of Rochester Medical Center-Strong Memorial Hospital

location_facility: 3920121 - Hokkaido Cardiovascular Hospital

location_facility: 6420052 - Spitalul Judeţean de Urgenţă "Dr. Constantin Opriş" Baia Mar

location_facility: 6420046 - Spitalului Universitar de Urgenţă Militar Central "Dr. Carol Davila"

location_facility: 7240043 - Hospital Universitario Fundación Alcorcón

location_facility: 8400613 - Jim Moran Heart and Vascular Center

location_facility: 0760038 - Instituto de Cardiologia do Distrito Federal (ICDF)

location_facility: 3000027 - GENERAL HOSPITAL Korgialenio - Benakio HRC

location_facility: 8400638 - Mid Michigan Regional Medical Center

location_facility: 8400996 - Southern Arizona V.A. Healthcare System

location_facility: 7240070 - Hospital Universitario Virgen Arrixaca

location_facility: 3800079 - Azienda Ospedaliera di Caserta "Sant'Anna e San Sebastiano"

location_facility: 7640018 - Maharat Nakhon Ratchasima Hospital

location_facility: 0760021 - Fundacao Hospitalar Sao Francisco de Assis

location_facility: 8401165 - Ascension Macomb-Oakland Hospital Warren Campus

location_facility: 8400759 - Winchester Cardiology and Vascular Medicine

location_facility: 7920030 - T. C. Saglık Bakanlıgı - Bagcılar Egitim ve Arastırma Hastan

location_facility: 8400496 - Advanced Cardiology Associates

location_facility: 0560036 - Universitair Ziekenhuis Leuven

location_facility: 7240032 - Hospital Universitari Joan XXIII de Tarragona

location_facility: 7240026 - Hospital General Universitario de Alicante

location_facility: 8400888 - Saint Jude Heritage Healthcare

location_facility: 7920014 - Mersin Üniversitesi Tip Fakültesi

location_facility: 2760184 - Praxis Dr. Med. Nicole Toursarkissian

location_facility: 6420060 - Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: 6430081 - Saint Petersburg State Medical Academy

location_facility: 6880024 - Opsta Bolnica "Dorde Joanovic" Zrenjanin

location_facility: 3480023 - Petz Aladar County Teaching Hospital

location_facility: 0760052 - Hospital Nossa Senhora da Conceicao (HNSC)

location_facility: 6430072 - Samara Regional Cardiology Dispensary

location_facility: 8400889 - NC Heart and Vascular Research

location_facility: 8400861 - Ascension Providence Rochester Hospital

location_facility: 0560019 - Centre Hospitalier Régional de Huy

location_facility: 4840025 - Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: 8400873 - Baptist Clinical Research Institute

location_facility: 2460011 - Turku University Hospital (TYKS)

location_facility: 3760035 - The Baruch Padeh Medical Center

location_facility: 8400881 - North Texas Research Associates

location_facility: 6200012 - Centro Hospitalar e Universitário do Algarve, EPE - Hospital

location_facility: 3760025 - Rabin Medical Center - Hasharon Hospital

location_facility: 7640020 - Buddhachinaraj Hospital Phitsanuloke

location_facility: 2760164 - Elisabeth-Krankenhaus Essen GmbH Klinik für Kardiologie und Angiologie

location_facility: 8400717 - V.A. Greater Los Angeles Healthcare System

location_facility: 8400500 - Tennova Health Care - Turkey Creek Medical Center

location_facility: 2760170 - Charite - UB - CVK - Medizinische Klinik

location_facility: 6420057 - Institutul de Boli Cardiovasculare "Prof. Dr. George I. M. Georgescu

location_facility: 8401178 - Jersey Shore University Medical Center Meridian Health

location_facility: 1000047 - University Hospital for Active Treatment & Emergency Medicine

location_facility: 6430060 - Regional State Budgetary Institution of Public Health

location_facility: 0760011 - Hospital Cardiologico Costantini

location_facility: 8400733 - Novant Health Heart and Vascular Institute

location_facility: 4580015 - Hospital Universiti Sains Malaysia

location_facility: 4280005 - SIA Rigas Austrumu Kliniska Universitates Slimnica - Gaileze

location_facility: 0760075 - Instituto D'Or de Pesquisa e Ensino

location_facility: 7030002 - Svet zdravia, a.s. - Všeobecná nemocnica Rimavská Sobota

location_facility: 7240034 - Hospital Clinico Universitario de Valencia

location_facility: 8260058 - Royal Devon & Exeter NHS Foundation Trust

location_facility: 8040019 - Cherkasy Regional Cardiological Center

location_facility: 8260065 - Milton Keynes Hospital NHS Foundation Trust

location_facility: 1700007 - Fundacion Cardiomet Eje Cafetero CEQUIN

location_facility: 3920109 - National Hospital Organization Kumamoto Medical Center

location_facility: 5280054 - Noordwest Ziekenhuisgroep - Alkmaar

location_facility: 6420079 - Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: 2500078 - Centre Hospitalier Louis Pasteur

location_facility: 8400503 - The Heart and Vascular Center / Holy Family Memorial

location_facility: 1240058 - University of Alberta Hospital

location_facility: 4840007 - Unidad de Prevención y Atención Cardiometabólica (UPAC)

location_facility: 2500091 - CHRU Montpellier - Arnaud de Villeneuve

location_facility: 4100013 - Kyung Hee University Medical Center

location_facility: 6430070 - Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

location_facility: 8401011 - Cardiology Partners Research Institute

location_facility: 6430107 - Clinical Hospital of the Russian Academy of Science

location_facility: 1700024 - Fundación Hospitalaria San Vicente de Paul

location_facility: 0760027 - CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: 0760041 - Hospital e Maternidade Dr. Christovao da Gama

location_facility: 8400482 - Amarillo Heart Clinical Research Institute

location_facility: 0760083 - Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: 1700006 - Hospital Universitario San Ignacio

location_facility: 8400836 - Our Lady of Lourdes Medical Center

location_facility: 1000024 - Multiprofile District Hospital

location_facility: 8400745 - Hoag Memorial Hospital Presbyterian

location_facility: 8400648 - Saint Luke's Cardiovascular Consultants

location_facility: 8401054 - Central Cardiology Medical Center

location_facility: 3760018 - Leviev Heart Center, Chaim Sheba Medical Center

location_facility: 7030001 - Nemocnica arm. Generala L. Svobodu Svidnik, a.s.

location_facility: 3920095 - Showa University Fujigaoka Hospital

location_facility: 0760068 - Gutierrez Cardiologia Clinica e Intervencionista Ltda.

location_facility: 6430050 - Kursk City Emergency Care Hospital

location_facility: 8400570 - Advanced Cardiology Specialists

location_facility: 0760018 - Pronto Socorro Cardiológico de Pernambuco (PROCAPE)

location_facility: 6420080 - Spitalul Clinic de Recuperare Cluj-Napoca

location_facility: 2500117 - Centre Chirurgical Marie Lannelongue

location_facility: 3760034 - Assaf Harofeh Medical Center - Cardiology Division

location_facility: 3920120 - National Cerebral and Cardiovascular Center

location_facility: 4840016 - Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: 4100024 - Seoul National University Bundang Hospital

location_facility: 0320019 - Hospital Británico de Buenos Aires

location_facility: 5280036 - Canisius-Wilhelmina Ziekenhuis

location_facility: 0320054 - Clínica Privada de Especialidades Médicas de Villa María

location_facility: 6430043 - Tula Regional Clinical Hospital

location_facility: 1520004 - Hospital Dr. Hernan Henriquez Aravena

location_facility: 2080022 - Amager Sygehus - Kardiologisk Klinik

location_facility: 6430045 - Penza Regional Clinical Hospital n.a. N.N.Burdenko

location_facility: 0320044 - Instituto Medico de la Fundacion de Estudios Clínicos

location_facility: 0760040 - Santa Casa de Misericordia de Pelotas

location_facility: 0760047 - Instituto de Cardiologia de Santa Catarina (ICSC)

location_facility: 0400028 - Medizinische Universitaet Innsbruck - Universitaetsklinik für Innere Medizin

location_facility: 8400544 - Cardiology Research Associates

location_facility: 8260055 - NHS National Waiting Times Centre Golden Jubilee National Hospital

location_facility: 3480026 - Zala Megyei Szent Rafael Kórház

location_facility: 8401144 - Saint Michael's Medical Center

location_facility: 3920118 - Sapporo Medical University Hospital

location_facility: 6430058 - State Budget Healthcare Institution of Novosibirsk Region "C

location_facility: 8040047 - Oleksandrivska Clinical Hospital

location_facility: 1240113 - Niagara Health System, St. Catherines Site

location_facility: 0560026 - Universitair Ziekenhuis Brussel

location_facility: 2760176 - Evangelisches Krankenhaus Witten

location_facility: 3920104 - Shizuoka City Shizuoka Hospital

location_facility: 6160083 - Wojewódzki Szpital Specjalistyczny im. Marii Skłodowskiej-Curie

location_facility: 6430048 - City Clinical Hospital No. 6 named after Karpovicha

location_facility: 0760035 - Loema - Instituto de Pesquisa Clinica

location_facility: 2030038 - Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze

location_facility: 1000072 - Multiprofile Hospital for Active Treatment - Dobrich AD

location_facility: 3000022 - University of Athens - Hippokration General Hospital

location_facility: 8400491 - Moses H. Cone Memorial Hospital

location_facility: 8400893 - Interventional Cardiology Medical Group

location_facility: 2080021 - Amager and Hvidovre Hospital - Medical Department

location_facility: 8400357 - Saint Luke's Boise Medical Center

location_facility: 8400694 - University of California San Diego Medical Center

location_facility: 4100020 - Kyung Hee University Hospital at Gangdong

intervention_type: Biological


type: EudraCT Number

title: A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies

summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
Italy
Austria
Australia
Netherlands
Thailand
Korea, Republic of
United States
France
Israel
Singapore
Turkey
Germany

location_facility: Memorial Sloan Kettering Cancer Center Onc. Dept..

location_facility: Thomas Jefferson University Hospital Onc Dept

location_facility: University of Colorado Dept. of Anschutz Cancer (3)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

lead_sponsor: Boehringer Ingelheim

source: euctr

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7.

location_country:
Philippines
India
United States
France

location_facility: 1218.61.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01018 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01031 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01030 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01016 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01048 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01040 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01042 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3309A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01046 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01044 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01015 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01024 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01053 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01027 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3311A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01007 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01017 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01023 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3310A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01049 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01052 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3313A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01028 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01043 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01020 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01014 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3312A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3307A Boehringer Ingelheim Investigational Site

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.


acronym: LUX-Lung 3

title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Märten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

ReferenceCitation: Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Märten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. Epub 2016 Sep 6.

ReferenceCitation: Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.

ReferenceCitation: Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.

ReferenceCitation: Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.

ReferenceCitation: Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.

ReferenceCitation: Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.

ReferenceCitation: Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.

location_country:
United Kingdom
Italy
Ukraine
United States
Peru
Romania
Philippines
Belgium
Japan
Hong Kong
Austria
Australia
Russian Federation
Argentina
Malaysia
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
Thailand
Korea, Republic of
France
Chile

location_facility: Lviv State Oncological Regional Treatment & Diagnostic CTR

location_facility: Chonnam National University Hwasun Hospital

location_facility: UNIFESP Departamento de Medicina de Pneumologia

location_facility: Clinical Trials and Research Associates Inc

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Republic Clinical Oncology Dispensary, Dept. Chemotherapy

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: Lehigh Valley Hospital / Lehigh Valley Health Network

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

location_facility: South Texas Institute of Cancer, Northwest Cancer Center

location_facility: FSBSI "N.N Blokhin Medical Research Center of Oncology"

location_facility: Hospital Dirección de Previsión de Carabineros

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Instituto de Medicina Nuclear de Bahía Blanca

location_facility: McGill University, Department of Oncology

location_facility: First Pavlov State Medical University Saint Petersburg

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Instituto Oncológico Limitada Viña del Mar

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Hematologiste et oncologue medical CHUM - Hopital Notre-Dame

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital São Lucas da Pontifícia Universidade Católica

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Markusovszky County Hospital, Szombathely

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Seoul National University Bundang Hospital

location_facility: Innovative Medical Research of South Florida

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Universitätsklinikum Benjamin Franklin, Berlin

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Centro de Pesquisa do Hospital Lifecenter

location_facility: Cross Cancer Institute (University of Alberta)

summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.


title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

acronym: ADVANCE-ON

summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Patel A; ADVANCE Collaborative Group, MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007 Sep 8;370(9590):829-40.

ReferenceCitation: ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.

ReferenceCitation: Wang N, Harris K, Hamet P, Harrap S, Mancia G, Poulter N, Williams B, Zoungas S, Woodward M, Chalmers J, Rodgers A. Cumulative Systolic Blood Pressure Load and Cardiovascular Risk in Patients With Diabetes. J Am Coll Cardiol. 2022 Sep 20;80(12):1147-1155. doi: 10.1016/j.jacc.2022.06.039.

ReferenceCitation: Oshima M, Jun M, Ohkuma T, Toyama T, Wada T, Cooper ME, Hadjadj S, Hamet P, Harrap S, Mancia G, Marre M, Williams B, Chalmers J, Woodward M, Perkovic V; ADVANCE Collaborative Group. The relationship between eGFR slope and subsequent risk of vascular outcomes and all-cause mortality in type 2 diabetes: the ADVANCE-ON study. Diabetologia. 2019 Nov;62(11):1988-1997. doi: 10.1007/s00125-019-4948-4. Epub 2019 Jul 13.

ReferenceCitation: Mohammedi K, Woodward M, Hirakawa Y, Zoungas S, Colagiuri S, Hamet P, Harrap S, Poulter N, Matthews DR, Marre M, Chalmers J; ADVANCE Collaborative Group. Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON study. Cardiovasc Diabetol. 2016 Sep 2;15(1):129. doi: 10.1186/s12933-016-0446-x.

ReferenceCitation: Wong MG, Perkovic V, Chalmers J, Woodward M, Li Q, Cooper ME, Hamet P, Harrap S, Heller S, MacMahon S, Mancia G, Marre M, Matthews D, Neal B, Poulter N, Rodgers A, Williams B, Zoungas S; ADVANCE-ON Collaborative Group. Long-term Benefits of Intensive Glucose Control for Preventing End-Stage Kidney Disease: ADVANCE-ON. Diabetes Care. 2016 May;39(5):694-700. doi: 10.2337/dc15-2322. Epub 2016 Mar 22.

ReferenceCitation: Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; ADVANCE-ON Collaborative Group. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014 Oct 9;371(15):1392-406. doi: 10.1056/NEJMoa1407963. Epub 2014 Sep 19.

lead_sponsor: The George Institute

location_country:
Poland
United Kingdom
Ireland
Italy
Estonia
Australia
Canada
Czech Republic
Lithuania
Netherlands
New Zealand
Hungary
Russian Federation
France
India
China
Malaysia
Philippines
Germany
Slovakia

location_facility: LCC 643 - 2nd Aff Hospital of Baotou Medical College

location_facility: LCC 902 - University of Malaya Medical Centre

location_facility: LCC 452 - Centre de recherche clinique de Laval

location_facility: LCC 618 - Hebei Academy of Medical Sciences

location_facility: LCC 424 - Research Institute of Cardiology

location_facility: LCC 273 - Institute Psychophysiology and Rehabilitation

location_facility: LCC 633 - Cardiovascular Institute & Fu Wai Hospital

location_facility: LCC 614 -The First Affiliated Hospital of Henan Medical University

location_facility: LCC 622 - The First People's Hospital of Lianyungang City

location_facility: LCC 468 - Calgary Metabolic Education and Research Centre

location_facility: Universiti Kebangsaan Malaysia & Universiti Teknologi MARA

location_facility: LCC 641 - The 2nd Aff Hospital of Harbin Medical University

location_facility: LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii

location_facility: LCC 653 - Aff Hospital of Anhui Medical University

location_facility: LCC 647 - First Hospital of Yang Quan City

location_facility: LCC 644 - Baotou Iron & Steel Corporation's Hospital,

location_facility: LCC 613 - Cardiovascular Institute of Shanxi Province

location_facility: LCC 630 - Beijing Hypertension League Institute

location_facility: LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University

location_facility: LCC 330 - Klinikyum der Universitat Munchen

location_facility: LCC 661 - Institute of Gerontology of Benxi City

location_facility: LCC 651 - Jiangsu Institute of Geriatrics,

location_facility: LCC 354 - Stichting Huisartsen Laboratorium

location_facility: LCC 356 - Huisartsenpraktijk Tollenslaan

location_facility: LCC 336 - Heart Center Foundation-DRC Ltd

location_facility: LCC 638 - Shanghai 6th People's Hospital

location_facility: LCC 636 - Chang Zheng Hospital of Shanghai

location_facility: LCC 627 - Peking Union Medical College Hospital

location_facility: LCC 816 - Peninsula Medical School Headquarters

location_facility: LCC 394 - II Oddzial Chorob Wewnetrznvch

location_facility: LCC 466 - Centre de recherche d'endocrinologie

location_facility: LCC 421 - St Petersburg State Medical University

location_facility: LCC 619 - The First Hospital of Ning Bo City Municipal

location_facility: LCC 639 - Metabolic Disease Hospital of Tianjin Medical University

location_facility: LCC 626 - First Hospital of Peking University

location_facility: LCC 109 - Rural Clinical Trials Research Unit

location_facility: LCC 616 - Center Hospital of Zhumadian City

location_facility: LCC 606 - Shandong Academy of Medical Sciences,

location_facility: LCC 646 - The 2nd Aff Hospital of Hebei Medical University

location_facility: LCC 658 - The 1st Aff Hospital of Guiyang Medical College

location_facility: LCC 642 - The Institute of Aged Gerontology of Inner Mongolia

location_facility: LCC 420 - Russian Peoples Friendship University

location_facility: LCC 809 - Royal Liverpool University Hospital

location_facility: LCC 453 - Centre hospitalier de l'Universite de Montreal

location_facility: LCC 660 - Shandong Academy of Medical Sciences

location_facility: LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke

location_facility: LCC 607 - People's Hospital of Binzhou City

location_facility: LCC 637 - Chinese Air Force General Hospital

location_facility: LCC 655 - The 1st Aff Hospital of Jiangxi Medical College

location_facility: LCC 467 - Queen Elizabeth II Health Science Centre

location_facility: LCC 632 - Dept Endocrinology Beijing 306 Hospital

location_facility: LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University

location_facility: LCC 315 - Hôpital Jean Bernard la Miletrie

location_facility: LCC 741 - Madras Diabetic Research Foundation

location_facility: LCC 620 - Municipal Hospital of Chengdou

location_facility: LCC 610 - Second Affiliated Hospital of Dalian Medical University

location_facility: LCC 376 - CH Avignon - Hôpital Henri Duffaut

location_facility: LCC 624 - The First Affiliated Hospital of Fujian Medical University


title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

lead_sponsor: Pfizer

ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Review.

ReferenceCitation: Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crinò L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.

ReferenceCitation: Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.

ReferenceCitation: Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Jänne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

ReferenceCitation: Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Hong Kong
Russian Federation
Australia
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands

location_facility: Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Santa Monica-UCLA Medical Center and Orthopaedic Hospital

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

location_facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)

location_facility: Zhongshan Hospital Fudan University / Respiratory Department

location_facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

location_facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

location_facility: Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department

location_facility: University General Hospital of Heraklion/ Department of Clinical Oncology

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: National Cancer Center, Center for Lung Cancer

location_facility: Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren

location_facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine

location_facility: Washington University, School of Medicine

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)

location_facility: Ingalls Memorial Hospital (Drug Shipment Only)

location_facility: University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika

location_facility: Georgia Cancer Specialists-Administrative Annex

location_facility: Pest Megyei Tudogyogyintezet, III. Osztaly

location_facility: Alberta Health Services, Holy Cross Site

location_facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

location_facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

location_facility: State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region

location_facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

location_facility: University of California, Irvine-Medical Center

location_facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

location_facility: Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.

location_facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

location_facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

location_facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

location_facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: Southampton University Hospitals NHS Trust

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Hospital General Universitari Vall D´Hebron

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav

location_facility: A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati

location_facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

location_facility: University of Pittsburgh Medical Center-Shadyside

location_facility: Centre Rene Gauducheau / Service d'Oncologie Medicale

location_facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP

location_facility: Ship Drug to: Investigational Drug Services

location_facility: Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA

location_facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

location_facility: Karolinska Universitetssjukhuset, Onkologiska kliniken

location_facility: Institut Catala Doncologia - Hospital Duran I Reynals

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Unviersity of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion

location_facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

location_facility: Shanghai Pulmonary Hospital/Dept. of Oncology

location_facility: Investigational Drug Service, Pharmacy Department, UNC Hospitals

location_facility: Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Taipei Veterans General Hospital, Chest Department

location_facility: Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Cancer Center of South Florida Foundation, Inc.

location_facility: University of California Davis Medical Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Hospital Universitario Central de Asturias

location_facility: MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi

location_facility: Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin

summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


title: Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

ReferenceCitation: Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Jänne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeño JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017.

ReferenceCitation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186. Review.

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Medical University of South Carolina - Hollings Cancer Center

location_facility: RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa

location_facility: Lisa Nakatsu, RPh (Drug Shipment Address)

location_facility: Ronald Reagen University of California-Los Angeles Medical Center

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

location_facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

location_facility: Zhongshan Hospital Fudan University / Respiratory Department

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Sarah Cannon Research Institute (Pharmacy)

location_facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

location_facility: SUNY Upstate Medical University, Regional Oncology Center

location_facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department

location_facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

location_facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: University General Hospital of Heraklion/ Department of Clinical Oncology

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: Drug Shipping Address: Ronald Reagen University of California-Los Angeles

location_facility: Karmanos Cancer lnstitute at Farmington Hllls

location_facility: National Cancer Center, Center for Lung Cancer

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill

location_facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: Samsung Medical Center, Sungkyunkwan Univ School of Medicine

location_facility: Pest Megyei Tudogyogyintezet, III. Osztaly

location_facility: Ingalls Memorial Hospital (Drug Shipment Only)

location_facility: Alberta Health Services, Holy Cross Site

location_facility: National Kyushu Cancer Center/Department of Thoracic Oncology

location_facility: Smilow Cancer Center at Yale New Haven, Oncology Pharmacy

location_facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

location_facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

location_facility: University of California, Irvine-Medical Center

location_facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

location_facility: Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera

location_facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

location_facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

location_facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

location_facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: The Harry and Jeanette Cancer Research Building

location_facility: National Institutes of Health National Cancer Institute

location_facility: University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of California, Irvine-Pharmacy

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Hospital General Universitari Vall D´Hebron

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: The Ohio State University Investigational Drug Services

location_facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav

location_facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

location_facility: Centre Rene Gauducheau / Service d'Oncologie Medicale

location_facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP

location_facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department

location_facility: Karolinska Universitetssjukhuset, Onkologiska kliniken

location_facility: MCG Health System Pharmacy (Drug Shipment Only)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia

location_facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: University of Hawaii - Cancer Research Center of Hawaii

location_facility: Memorial Sloan - Kettering Cancer Center

location_facility: Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Ship drug to: Investigational Drug Services

location_facility: Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory

location_facility: University of Texas Southwestern University Hospital - Zale Lipshy

location_facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

location_facility: Michael and Dianne Bienes Cancer Center, Holy Cross Hospital

location_facility: Beth Isreal Deaconess Medical Center, Pharmacy FD B18

location_facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

location_facility: UT Southwestern University Hospital - William P. Clements, Jr

location_facility: Indiana University Hospital Clarian Health

location_facility: University of Arkansas for Medical Sciences

location_facility: Sarah Cannon Research Institute (Administration)

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej

location_facility: DRUG SHIPMENT: University of Colorado Cancer Center

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Georgia Cancer Specialists - Administrative Annex

location_facility: Institut Catala D'Oncologia - Hospital Duran I Reynals

summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


title: A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Voi M, Gnant M, Hortobagyi G, Baselga J, Moynahan ME. Prevalence of ESR1 Mutations in Cell-Free DNA and Outcomes in Metastatic Breast Cancer: A Secondary Analysis of the BOLERO-2 Clinical Trial. JAMA Oncol. 2016 Oct 1;2(10):1310-1315. doi: 10.1001/jamaoncol.2016.1279. Erratum in: JAMA Oncol. 2019 Jan 1;5(1):122.

ReferenceCitation: Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA 3rd, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, Shtivelband M, Masuda N, Dakhil S, Anderson I, Robinson DM, He W, Garg A, McDonald ER 3rd, Bitter H, Huang A, Taran T, Bachelot T, Lebrun F, Lebwohl D, Baselga J. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016 Feb 10;34(5):419-26. doi: 10.1200/JCO.2014.60.1971. Epub 2015 Oct 26. Erratum in: J Clin Oncol. 2019 Feb 1;37(4):354. J Clin Oncol. 2019 Feb 1;37(4):355.

ReferenceCitation: Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA 3rd, Provencher L, Neven P, Gnant M, Shtivelband M, Wu C, Fan J, Feng W, Taran T, Baselga J. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†. Ann Oncol. 2014 Dec;25(12):2357-2362. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

ReferenceCitation: Rugo HS, Pritchard KI, Gnant M, Noguchi S, Piccart M, Hortobagyi G, Baselga J, Perez A, Geberth M, Csoszi T, Chouinard E, Srimuninnimit V, Puttawibul P, Eakle J, Feng W, Bauly H, El-Hashimy M, Taran T, Burris HA 3rd. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol. 2014 Apr;25(4):808-815. doi: 10.1093/annonc/mdu009. Epub 2014 Mar 10.

ReferenceCitation: Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25. Erratum in: Adv Ther. 2014 Sep;31(9):1008-9.

ReferenceCitation: Campone M, Beck JT, Gnant M, Neven P, Pritchard KI, Bachelot T, Provencher L, Rugo HS, Piccart M, Hortobagyi GN, Nunzi M, Heng DY, Baselga J, Komorowski A, Noguchi S, Horiguchi J, Bennett L, Ziemiecki R, Zhang J, Cahana A, Taran T, Sahmoud T, Burris HA 3rd. Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy. Curr Med Res Opin. 2013 Nov;29(11):1463-73. doi: 10.1185/03007995.2013.836078. Epub 2013 Sep 4.

ReferenceCitation: Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer. 2014 Nov;21(6):703-14. doi: 10.1007/s12282-013-0444-8. Epub 2013 Feb 13.

ReferenceCitation: Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Hong Kong
Austria
Australia
Turkey
Norway
Sweden
Egypt
Brazil
Canada
Hungary
Germany
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

location_facility: Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc

location_facility: Maryland Hematology/Oncology Associates, P.A.

location_facility: Trinitas Comprehensive Cancer Center Dept. of Trinitas

location_facility: The Angeles Clinic and Research Institute

location_facility: Frederick Memorial Hospital Dept. of FMH-IRB

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: University of Louisville / James Graham Brown Cancer Center SC

location_facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

location_facility: Southeast Nebraska Oncology Cancer Center

location_facility: Weill Cornell Medical College Weill Cornell Med. Ctr.

location_facility: Mercy Medical Center Medical Oncology & Hematology

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: Rush University Medical Center Study Coordinator

location_facility: Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma

location_facility: Hematology Oncology Association of Rockland

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

location_facility: Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2

location_facility: Florida Medical Clinic PA Dept.ofFloridaMedicalClinic

location_facility: St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

location_facility: Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA

location_facility: University of New Mexico Cancer Research Center Dept of UNM Cancer & Research

location_facility: Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Sharp Memorial Hospital SharpClinicalOncologyResearch

location_facility: St Joseph Heritage Healthcare Dept. of RRMG (4)

location_facility: University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (3)

location_facility: University of California San Francisco UCSF Medical Center

location_facility: Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ

location_facility: Memorial Hospital Memorial Cancer Institute

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)

location_facility: University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)

location_facility: Anne Arundel Health System Research Institute Wayson Pavilion

location_facility: Cancer Care Associates Dept.ofCancerCareAssoc. (2)

location_facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

location_facility: Hematology Oncology Clinic Hematology Oncology Clinic (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)

location_facility: Regional Cancer Care Associates Dept. of the CCHD

location_facility: Oncology Specialists, SC Dept.of Oncology Specialists

summary: There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.


status: Terminated

acronym: OLLTT

title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Poland
Brazil
Portugal
Spain
United Kingdom
Austria
Mexico
Netherlands
Czech Republic
United States
France
South Africa
Belgium
Germany

location_facility: Clínica Universitaria de Navarra, Dept. ORL

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Instituto Biomédico de Investigación A.C.

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Hospital Puerta del Hierro, Madrid- Servicio de ORL

location_facility: Centre Hospitalier de Bretagne Sud Service ORL-B9

location_facility: Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery

location_facility: Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag

location_facility: Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología

location_facility: Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia

location_facility: Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Monterrey International Research Center (MIRC)

location_facility: Hospital Universitario de Salamanca- Hospital Virgen de la Vega

location_facility: The university Hospitals of Leicester, Leicester Royal Infirmary

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: Hospital Clínico Barcelona, Dept. Of ORL

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: University of Kansas Department of Otolaryngology Head & Neck Surgery

location_facility: Hospital General de Chihuahua. "Dr. Salvador Anchondo"

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Unidad Médica de Especialidades del Noroeste (UMEN)

location_facility: ORL oddělení , Karlovarská krajská nemocnice a. s.

location_facility: Fundación Hospital de Alcorcón, Otorhinolaryngology

location_facility: ORL oddělení, Karlovarská krajská nemocncie a.s.

location_facility: University Hospital Leuven, ENT Department

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Montefiore Medical Center Attn: Anxiety and Depression Center

location_facility: Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.

location_facility: Erie County Medical Center, Department of Rehabilitation Medicine

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: UC Davis Health System Department of Otolaryngology

location_facility: Clin Pharm International GmbH, Zentrum Wien

location_facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

location_facility: Teaching University Hospital, ORL klinika

summary: The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

status_simplified: Unknown


title: A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

acronym: EFFICACY-HF

summary: This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

lead_sponsor: Vifor Pharma

location_country: Denmark France Israel Netherlands Germany