lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

sponsor_collaborators: EMD Serono Research & Development Institute, Inc.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

location_facility: CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia

location_facility: University Clinic for Pulmonary Diseases

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

location_facility: CI Kryvyi Rih Oncological Dispensary of DRC

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

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Murmansk Regional Clinical Hospital named after Bayandin

location_facility: Harbin Medical University Cancer Hospital

location_facility: Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

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

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

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

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Seconda Università degli Studi di Napoli

location_facility: The Catholic University of Korea, Yeouido St. Mary's Hospital

location_facility: Okmeydani Research and Training Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)

location_facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Kartal Lutfi Kirdar Research and Training Hospital

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: SBIH "Samara Regional Clinical Oncological Dispensary"

location_facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

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

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Clinical Center Nis, Pulmonary Diseases Clinic

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Gallipoli Medical Research Foundation Ltd

location_facility: Adana Numune Training and Research Hospital

location_facility: SBIH "Leningrad Regional Oncological Dispensary"

location_facility: Fundación Oftalmológica de Santander - FOSCAL

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

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

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

location_facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

location_facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

location_facility: Baskent University Adana Application and Research Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente

location_facility: FSBHI Clinical research institute of phthisiopulmonology

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Hammoud Hospital University Medical Center

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Kemerovo SPI Regional Clinical Oncology Dispensary

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: University of Pretoria Oncology Department

location_facility: RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: American University of Beirut Medical Center

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: University General Hospital of Heraklion

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: SI S.P.Grygoriev Institute of Medical Radiology of NAMSU

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Ukraine
Romania
Lebanon
Belgium
China
Peru
Estonia
Italy
Cyprus
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


study_start_date_type: Actual

acronym: ELEVATE UC 12

intervention_type: Drug

lead_sponsor: Arena Pharmaceuticals

summary: The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: LTD Israeli-Georgian medical research clinic Helsicore

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Republican Clinical Hospital, ARENSIA Exploratory Medicine

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: SZTE AOK I.st dept. of Internal Medicine.

location_facility: Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum

location_facility: FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov

location_facility: The University of Texas at Austin Dell Medical School

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Government Medical College and Super Speciality Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga

location_facility: Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital San Juan de Dios Fundacion Cardiomet-Cequin

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: General Hospital "Dr. Tomislav Bardek" Koprivnica

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Marshall University Department of Clinical Research

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

location_facility: Clinica de la Mujer Centro de Investigaciones

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Iwate Medical University Uchimaru Medical Center

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Washington University School of Medicine

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie

location_facility: Instituto de Investigaciones Clínicas Quilmes SRL

location_facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

location_facility: Shiga University of Medical Science Hospital

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: Clinica farallones centro de investigaciones clinicas CIC

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Saint George Hospital University Medical Center

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Kocaeli University Research and Training Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: Great Lakes Medical Research, LLC - Harrisburg

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Karkonoskie Centrum Badan Klinicznych Lexmedica

location_facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Great Lakes Medical Research, LLC - Mentor

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: Medical center "Nov Rehabilitatsionen Tsentar" EOOD

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Spitalul Clinic Judetean de Urgenta Craiova

location_facility: KH der Barmherzigen Brüder Linz, Interne Abteilung

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: LLC "Multidisciplinary Medical Clinic "Anthurium"

location_facility: A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I

location_facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

location_facility: Hospital General Universitario de Alicante

location_facility: Hôpital Rangueil Service Gastro-entérologie et pancreatologie

location_facility: University Hospital Antwerp Gastroenterology and Hepatology Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Dr. Peter Bossuyt - GI Clinical Research Center

location_facility: S.C Delta Health Care S.R.L, Ponderas Academic Hospital

location_facility: Fundación Respirar- Centro Médico Dra. De Salvo

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

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

status: Completed

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Lebanon
Belgium
Moldova, Republic of
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Georgia
Russian Federation
Israel

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Daiichi Sankyo, Inc.

summary: This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

ReferenceType: background

ReferenceCitation: Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Hospital El Carmen Dr. Luis Valentin Ferrada

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: Instituto de Cardiologia do Rio Grande do Sul

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA"

location_facility: IMIP - Instituto de Medicina Integral Professor Fernando Figueira

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Hospital Nacional de Niños Benjamín Bloom

location_facility: Clinical Hospital Centre Cavale Blanche BREST

location_facility: Saint George University Hospital Medical Center

location_facility: Unidad de Cirugía Cardiovascular de Guatemala (UNICAR)

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: HMCG - Hospital e Maternidade Dr. Christovão da Gama

location_facility: University of Szeged, Department of Pediatrics

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Spectrum Health Helen DeVos Children's Hospital Grand Rapids

location_facility: Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Miami Miller School of Medicine

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi

location_facility: Unidad Nacional de Oncología Pediátrica (UNOP)

location_facility: Semmelweis University 2nd Department of Pediatrics

location_facility: Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology

location_facility: University Hospital Centre Zagreb, University of Zagreb School of Medicine

location_facility: American University of Beirut Medical Center

location_facility: UNIFESP - Universidade Federal de São Paulo

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

location_facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Children's Hospital & Clinics of Minnesota

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta

location_facility: Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Mersin University Health Research and Practice Hospital

location_facility: CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education

location_facility: Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases

location_facility: Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic"

title: A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

type: Registry Identifier

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Germany
Argentina
Brazil
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Portugal
Hungary
Denmark
United States
Kenya
Ukraine
India
Romania
Lebanon
El Salvador
Malaysia
Guatemala
Norway
Singapore
Netherlands
Korea, Republic of
Spain
Panama
Taiwan
Bulgaria
Russian Federation
Israel

ipd_sharing: Yes


title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone

acronym: REGENETEN

summary: The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.

status: Terminated

lead_sponsor: Smith & Nephew, Inc.

location_country:
United Kingdom
Hong Kong
Singapore
Australia
Switzerland
United States
Canada
France

location_facility: University Hospitals Coventry and Warwickshire

location_facility: The Royal Orthopaedic Hospital NHS Foundation Trust

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Royal National Orthopaedic Hospital NHS Trust

location_facility: Liverpool University Hospitals NHS Foundation Trust

intervention_type: Device

status_simplified: Unknown


acronym: IASIS

lead_sponsor: Cardeas Pharma

summary: To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

ReferenceType: derived

ReferenceCitation: Kollef MH, Ricard JD, Roux D, Francois B, Ischaki E, Rozgonyi Z, Boulain T, Ivanyi Z, Janos G, Garot D, Koura F, Zakynthinos E, Dimopoulos G, Torres A, Danker W, Montgomery AB. A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial. Chest. 2017 Jun;151(6):1239-1246. doi: 10.1016/j.chest.2016.11.026. Epub 2016 Nov 24.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

title: A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)

location_country:
Hungary
United States
Spain
Greece
Turkey
Puerto Rico
France

ipd_sharing: Undecided


title: A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM.

Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world.

Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: AbbVie

location_country:
Germany
Italy
Japan
United States
Spain
France

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222372

location_facility: Nagoya City University Hospital /ID# 222408

location_facility: National Cancer Center Hospital East /ID# 239436

location_facility: Dana-Farber Cancer Institute /ID# 222174

location_facility: University of Texas Southwestern Medical Center /ID# 223811

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 223014

location_facility: Emory University, Winship Cancer Institute /ID# 222922

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 223224

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222258

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 222303

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 223839

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 222302

location_facility: Universitaetsklinikum Muenster /ID# 222504

status_simplified: Ongoing


type: Other Identifier

type: U.S. NIH Grant/Contract

title: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

ReferenceCitation: Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Martin M, Kelly CM, Ruiz-Borrego M, Gil-Gil M, Arce-Salinas CH, Brain EGC, Lee ES, Pierga JY, Bermejo B, Ramos-Vazquez M, Jung KH, Ferrero JM, Schott AF, Shak S, Sharma P, Lew DL, Miao J, Tripathy D, Pusztai L, Hortobagyi GN. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021 Dec 16;385(25):2336-2347. doi: 10.1056/NEJMoa2108873. Epub 2021 Dec 1.

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central

lead_sponsor: National Cancer Institute (NCI)

location_country:
Ireland
Colombia
Mexico
United States
Korea, Republic of
Saudi Arabia
Spain
Canada
Puerto Rico
France

location_facility: UCHealth University of Colorado Hospital

location_facility: Saint Vincent Hospital Cancer Center at Oconto Falls

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Saint Mary's Oncology/Hematology Associates of Marlette

location_facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

location_facility: Smilow Cancer Hospital Care Center at Saint Francis

location_facility: McLaren Cancer Institute-Northern Michigan

location_facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

location_facility: University of Kansas Cancer Center - Lee's Summit

location_facility: Ascension Columbia Saint Mary's Hospital - Milwaukee

location_facility: NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: TidalHealth Nanticoke / Allen Cancer Center

location_facility: Marshfield Clinic - Wisconsin Rapids Center

location_facility: Smilow Cancer Hospital Care Center - Guilford

location_facility: Kaiser Permanente Medical Center-Vacaville

location_facility: Cleveland Clinic Wooster Family Health and Surgery Center

location_facility: East Bay Medical Oncology Hematology Medical Associates-Antioch

location_facility: Wellmont Medical Associates Oncology and Hematology-Johnson City

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Kansas City NCI Community Oncology Research Program

location_facility: Michiana Hematology Oncology PC-Plymouth

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Rocky Mountain Cancer Centers-Greenwood Village

location_facility: Cancer Centers of Southwest Oklahoma Research

location_facility: Rocky Mountain Regional VA Medical Center

location_facility: Novant Health New Hanover Regional Medical Center

location_facility: Southeastern Medical Oncology Center-Clinton

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: University of Washington Medical Center - Montlake

location_facility: UPMC Washington Hospital Radiation Oncology

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: The Cancer Institute of New Jersey Hamilton

location_facility: Hawaii Cancer Care Inc - Waterfront Plaza

location_facility: American Fork Hospital / Huntsman Intermountain Cancer Center

location_facility: Western Illinois Cancer Treatment Center

location_facility: Geisinger Medical Center-Cancer Center Hazleton

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Smilow Cancer Hospital-Waterbury Care Center

location_facility: Providence Regional Cancer System-Shelton

location_facility: Natalie Warren Bryant Cancer Center at Saint Francis

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Atlantic Health Sciences Corporation-Saint John Regional Hospital

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: PEI Cancer Treatment Centre-Queen Elizabeth Hospital

location_facility: Cleveland Clinic Cancer Center Independence

location_facility: Christiana Care Health System-Wilmington Hospital

location_facility: UPMC-Heritage Valley Health System Beaver

location_facility: Anchorage Associates in Radiation Medicine

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: UPMC Hillman Cancer Center in Coraopolis

location_facility: Saint Joseph Radiation Oncology Resource Center

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Northeast Alabama Regional Medical Center

location_facility: Great Lakes Cancer Management Specialists-Macomb Professional Building

location_facility: Gaston Hematology and Oncology Associates

location_facility: Guthrie Medical Group PC-Robert Packer Hospital

location_facility: Grupo Espanol de Investigacion en Cancer de Mama

location_facility: Yale-New Haven Hospital North Haven Medical Center

location_facility: Freeport Memorial Hospital/Leonard C Ferguson Cancer Center

location_facility: Forrest General Hospital / Cancer Center

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: Siteman Cancer Center at Christian Hospital

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hematology and Oncology Associates-Oakland

location_facility: Mid-Illinois Hematology Oncology Associates Limited

location_facility: Legacy Emanuel Hospital and Health Center

location_facility: Fort Wayne Medical Oncology and Hematology Inc-Parkview

location_facility: Saint Louis Cancer and Breast Institute-South City

location_facility: Saint Mary's Oncology/Hematology Associates of West Branch

location_facility: Cleveland Clinic Cancer Center Beachwood

location_facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

location_facility: Louisiana State University Health Science Center

location_facility: Cleveland Clinic Cancer Center Mansfield

location_facility: Louisiana Hematology Oncology Associates LLC

location_facility: William E Kahlert Regional Cancer Center/Sinai Hospital

location_facility: Sidney Kimmel Cancer Center Washington Township

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - Valley

location_facility: George Washington University Medical Center

location_facility: Siteman Cancer Center at Saint Peters Hospital

location_facility: UPMC-Johnstown/John P. Murtha Regional Cancer Center

location_facility: Wellmont Holston Valley Hospital and Medical Center

location_facility: UH Seidman Cancer Center at Landerbrook Health Center

location_facility: Kaiser Permanente-Gaithersburg Medical Center

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: Sainte Genevieve County Memorial Hospital

location_facility: Institut de Cancerologie de l'Ouest-Rene Gauducheau

location_facility: Michiana Hematology Oncology PC-South Bend

location_facility: Novant Health Cancer Institute - Matthews

location_facility: Sanford USD Medical Center - Sioux Falls

location_facility: Marshfield Medical Center-EC Cancer Center

location_facility: Hematology Oncology Associates of Illinois - Skokie

location_facility: Palo Alto Medical Foundation-Camino Division

location_facility: Saint Vincent Hospital Cancer Center at Saint Mary's

location_facility: The Research Institute of the McGill University Health Centre (MUHC)

location_facility: Long Beach Memorial Medical Center-Todd Cancer Institute

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: UPMC Jefferson Regional Radiation Oncology

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Alta Bates Summit Medical Center-Herrick Campus

location_facility: Ascension Providence Hospitals - Southfield

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: Heartland Hematology and Oncology Associates Incorporated

location_facility: AtlantiCare Health Park-Cape May Court House

location_facility: Mercyhealth Hospital and Cancer Center - Janesville

location_facility: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: Suburban Community Hospital and Cancer Center

location_facility: Yale-New Haven Hospital Saint Raphael Campus

location_facility: IU Health Central Indiana Cancer Centers-East

location_facility: Lovelace Medical Center-Saint Joseph Square

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Ascension Columbia Saint Mary's Hospital Ozaukee

location_facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus

location_facility: Saint Alphonsus Cancer Care Center-Caldwell

location_facility: University Medical Center of Southern Nevada

location_facility: Aurora Health Care Germantown Health Center

location_facility: Tulane University Health Sciences Center

location_facility: Harrison HealthPartners Hematology and Oncology-Bremerton

location_facility: Trillium Health Partners - Queensway Health Centre

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Columbus NCI Community Oncology Research Program

location_facility: Kaiser Permanente - Largo Medical Center

location_facility: Cleveland Clinic Cancer Center Strongsville

location_facility: The University of Kansas Cancer Center-South

location_facility: Carolina Blood and Cancer Care Associates PA-Lancaster

location_facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay

location_facility: Saint James Community Hospital and Cancer Treatment Center

location_facility: Northwest NCI Community Oncology Research Program

location_facility: Kaiser Permanente-Capitol Hill Medical Center

location_facility: The Don and Sybil Harrington Cancer Center

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Smilow Cancer Hospital-Orange Care Center

location_facility: Seattle Cancer Care Alliance at EvergreenHealth

location_facility: Pulmonary Medicine Center of Chattanooga-Hixson

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Marshfield Clinic Cancer Center at Sacred Heart

location_facility: Institut Curie-Centre Rene Huguenin Saint Cloud

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: Central Illinois Hematology Oncology Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: CHI Saint Vincent Cancer Center Hot Springs

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Centre d'Oncologie et de Radiotherapie Pays Basque

location_facility: Mary Bird Perkins Cancer Center - Covington

location_facility: Smilow Cancer Hospital-Derby Care Center

location_facility: Medical Oncology Hematology Consultants PA

location_facility: Novant Health Cancer Institute - Mooresville

location_facility: University of Kentucky/Markey Cancer Center

location_facility: Southeast Nebraska Cancer Center - 68th Street Place

location_facility: Southern Illinois University School of Medicine

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: Steward Saint Elizabeth's Medical Center

location_facility: Hinsdale Hematology Oncology Associates Incorporated

location_facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

location_facility: Cancer Center of Kansas-Wichita Medical Arts Tower

location_facility: Hematology Oncology Associates of Illinois-Highland Park

location_facility: Karmanos Cancer Institute at McLaren Greater Lansing

location_facility: University of Tennessee Health Science Center

location_facility: Ascension Saint Francis - Reiman Cancer Center

location_facility: Harbin Clinic Medical Oncology and Clinical Research

location_facility: Washington University School of Medicine

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: Henry Ford Macomb Hospital-Clinton Township

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Kapiolani Medical Center for Women and Children

location_facility: University of Cincinnati Cancer Center-UC Medical Center

location_facility: University of Kansas Cancer Center - North

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Radiation Oncology Centers of Nevada Central

location_facility: Mercy Clinic-Rolla-Cancer and Hematology

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: Dayton NCI Community Oncology Research Program

location_facility: Michiana Hematology Oncology PC-Crown Point

location_facility: Gaston Hematology and Oncology Associates-Belmont

location_facility: Kaiser Permanente-Woodlawn Medical Center

location_facility: Palo Alto Medical Foundation-Gynecologic Oncology

location_facility: Great Lakes Cancer Management Specialists-Doctors Park

location_facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Texas Tech University Health Sciences Center-Lubbock

location_facility: Fairview Clinics and Surgery Center Maple Grove

location_facility: Providence Willamette Falls Medical Center

location_facility: Memorial Health University Medical Center

location_facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson

location_facility: Smilow Cancer Hospital Care Center - Waterford

location_facility: Avera McKennan Hospital and University Health Center

location_facility: Central Vermont Medical Center/National Life Cancer Treatment

location_facility: Hematology and Oncology Associates of North East Pennsylvania

location_facility: Saint Luke's Cancer Institute - Meridian

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Tenaya

location_facility: Novant Health Cancer Institute - Huntersville

location_facility: Novant Health Carolina Surgical - Randolph

location_facility: UC Comprehensive Cancer Center at Silver Cross

location_facility: Genesys Regional Medical Center-West Flint Campus

location_facility: BCCA-Cancer Centre for the Southern Interior

location_facility: Doctors Medical Center- JC Robinson Regional Cancer Center

location_facility: Saint Vincent Hospital Cancer Center Green Bay

location_facility: Southeast Clinical Oncology Research Consortium NCORP

location_facility: UH Seidman Cancer Center at Saint John Medical Center

location_facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore

location_facility: Saint Alphonsus Cancer Care Center-Nampa

location_facility: Marshfield Medical Center-River Region at Stevens Point

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: Michigan Breast Specialists-Macomb Township

location_facility: UMass Memorial Medical Center - University Campus

location_facility: Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

location_facility: Providence Saint Mary Regional Cancer Center

location_facility: Olive View-University of California Los Angeles Medical Center

location_facility: Green Bay Oncology Limited at Saint Mary's Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: Lowcountry Hematology Oncology PA-Mount Pleasant

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: Smilow Cancer Hospital Care Center-Fairfield

location_facility: Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: Cleveland Clinic Cancer Center/Fairview Hospital

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Cleveland Hematology and Oncology Associates PC

location_facility: Saint Alphonsus Medical Center-Baker City

location_facility: Kaiser Permanente Tysons Corner Medical Center

location_facility: Saint Alphonsus Cancer Care Center-Boise

location_facility: Saint Luke's Cancer Institute - Twin Falls

location_facility: Atrium Medical Center-Middletown Regional Hospital

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: Virginia Mason Bainbridge Island Medical Center

location_facility: Baptist Health Madisonville/Merle Mahr Cancer Center

location_facility: University Hospitals Parma Medical Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Puyallup

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: LSU Health Sciences Center at Shreveport

location_facility: Berkshire Medical Center - Cancer Center

location_facility: Florida Hospital Memorial Medical Center

location_facility: East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

location_facility: Associates In Hematology Oncology PC-Upland

location_facility: Regional West Medical Center Cancer Center

location_facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: University of Alabama at Birmingham Cancer Center

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: Maine Center for Cancer Medicine-Scarborough

location_facility: Tacoma/Valley Radiation Oncology Centers-Gig Harbor

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: California Pacific Medical Center-Pacific Campus

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

location_facility: Kaiser Permanente-Deer Valley Medical Center

location_facility: Ochsner LSU Health Monroe Medical Center

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: UC Irvine Health/Chao Family Comprehensive Cancer Center

location_facility: Saint Rose Ambulatory and Surgery Center

location_facility: Hattiesburg Clinic - Hematology/Oncology Clinic

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

location_facility: Northern Indiana Cancer Research Consortium

location_facility: McGill University Department of Oncology

location_facility: University of Vermont and State Agricultural College

location_facility: AtlantiCare Regional Medical Center -Main Campus

location_facility: Toledo Community Hospital Oncology Program CCOP

location_facility: Scotland Memorial Hospital-Laurinburg Cancer Center

location_facility: Southeastern Medical Oncology Center-Goldsboro

location_facility: Tacoma/Valley Radiation Oncology Centers-Jackson Hall

location_facility: McLaren Cancer Institute-Central Michigan

location_facility: Virginia Mason Federal Way Medical Center

location_facility: Our Lady of the Lake Physicians Group - Medical Oncology

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: Coborn Cancer Center at Saint Cloud Hospital

location_facility: McFarland Clinic - Trinity Cancer Center

location_facility: Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

location_facility: Clinique Victor Hugo-Centre Jean Bernard

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - North

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

location_facility: South Georgia Medical Center/Pearlman Cancer Center

location_facility: Valley Medical Oncology Consultants-Castro Valley

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: Christus Saint Vincent Regional Cancer Center

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Indiana University/Melvin and Bren Simon Cancer Center

location_facility: University of Maryland Shore Medical Center at Easton

location_facility: Saint Mary's Hospital and Regional Medical Center

location_facility: Cancer Center-Metro Medical Center Bayamon

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: Hopital Prive Drome Ardeche-Clinique Pasteur

location_facility: Michigan Cancer Research Consortium NCORP

location_facility: Prisma Health Cancer Institute - Laurens

location_facility: Green Bay Oncology at Saint Vincent Hospital

location_facility: Presbyterian - Saint Lukes Medical Center - Health One

location_facility: Oncology Hematology Associates of Saginaw Valley PC

location_facility: Siteman Cancer Center at West County Hospital

location_facility: University of Cincinnati Cancer Center-West Chester

location_facility: PeaceHealth United General Medical Center

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: Trinity Health IHA Medical Group Hematology Oncology - Canton

location_facility: Saint Patrick Hospital - Community Hospital

location_facility: Minnesota Oncology Hematology PA-Maplewood

location_facility: Lowcountry Hematology Oncology PA-North Charleston

location_facility: Arnot Ogden Medical Center/Falck Cancer Center

location_facility: Columbus Oncology and Hematology Associates Inc

location_facility: Institut de Cancerologie de l'Ouest- Angers

location_facility: Mayo Clinic Health System-Franciscan Healthcare

location_facility: Kansas Institute of Medicine Cancer and Blood Center

location_facility: Wayne State University/Karmanos Cancer Institute

location_facility: The James Graham Brown Cancer Center at University of Louisville

location_facility: Comprehensive Cancer Centers of Nevada-Horizon Ridge

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: HealthCare Partners Medical Group Oncology/Hematology-San Martin

location_facility: Franciscan Research Center-Northwest Medical Plaza

location_facility: Garneau, Stewart C MD (UIA Investigator)

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: Memorial Regional Cancer Center Day Road

location_facility: Saint Luke's Cancer Institute - Fruitland

location_facility: AMITA Health Cancer Institute and Outpatient Center

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: West Virginia University Charleston Division

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: Montefiore Medical Center-Weiler Hospital

location_facility: Radiation Oncology Centers of Nevada Southeast

location_facility: Novant Health Presbyterian Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Carolina Blood and Cancer Care Associates PA

location_facility: Cooper Hospital University Medical Center

location_facility: Cancer Research Consortium of West Michigan NCORP

location_facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton

location_facility: East Bay Medical Oncology Hematology Associates Inc

location_facility: Comprehensive Cancer Centers of Nevada - Northwest

location_facility: HaysMed University of Kansas Health System

location_facility: Seoul National University Bundang Hospital

location_facility: Cotton O'Neil Cancer Center / Stormont Vail Health

location_facility: Michiana Hematology Oncology PC-Mishawaka

location_facility: Genesis Healthcare System Cancer Care Center

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Mountain Blue Cancer Care Center - Swedish

location_facility: MidHudson Regional Hospital of Westchester Medical Center

location_facility: Centra Lynchburg Hematology-Oncology Clinic Inc

location_facility: Montefiore Medical Center - Moses Campus

location_facility: Instituto Nacional De Cancerologia de Mexico

location_facility: Owensboro Health Mitchell Memorial Cancer Center

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: Smilow Cancer Hospital-Torrington Care Center

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Southeastern Medical Oncology Center-Jacksonville

location_facility: Franciscan Saint Anthony Health-Michigan City

location_facility: Vanderbilt-Ingram Cancer Center Cool Springs

location_facility: Minnesota Oncology Hematology PA-Woodbury

location_facility: University of Kansas Health System Saint Francis Campus

location_facility: Wichita NCI Community Oncology Research Program

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Providence Regional Cancer System-Aberdeen

location_facility: Great Lakes Cancer Management Specialists-Rochester Hills

location_facility: Halifax Health Medical Center-Centers for Oncology

location_facility: Hematology Oncology Associates of Fredericksburg Inc

location_facility: Michigan Breast Specialists-Grosse Pointe Woods

location_facility: CHU de Quebec-Hopital du Saint-Sacrement (HSS)

location_facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Palo Alto Medical Foundation Health Care

location_facility: UPMC Cancer Centers - Arnold Palmer Pavilion

location_facility: Constantinou, Costas L MD (UIA Investigator)

location_facility: Texas Tech University Health Sciences Center-El Paso

location_facility: Harrison HealthPartners Hematology and Oncology-Poulsbo

location_facility: Toledo Clinic Cancer Centers-Bowling Green

location_facility: UH Seidman Cancer Center at Lake Health Mentor Campus

location_facility: Wilcox Memorial Hospital and Kauai Medical Clinic

location_facility: Dana Farber Community Cancer Care-Quincy

location_facility: Northeast Georgia Medical Center-Gainesville

location_facility: Lincoln Medical and Mental Health Center

location_facility: Wellmont Medical Associates Oncology and Hematology-Bristol

location_facility: Dell Seton Medical Center at The University of Texas

location_facility: Penn State Milton S Hershey Medical Center

location_facility: UPMC Uniontown Hospital Radiation Oncology

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Lowcountry Hematology Oncology PA-West Ashley

location_facility: Kaiser Permanente - Kensington Medical Center

location_facility: Departemental Hospitalier Roche-sur-Yon (Les Oudairies)

location_facility: Providence Regional Cancer System-Centralia

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: State University of New York Upstate Medical University

location_facility: The Dana-Farber Cancer Institute at Londonderry

location_facility: University Hospitals Sharon Health Center

location_facility: Delaware Health Center-Grady Cancer Center

location_facility: Illinois CancerCare-Community Cancer Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Saint Joe's

location_facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation

location_facility: Mercy Clinic Oncology and Hematology-Ardmore

location_facility: Trinity Health Saint Mary Mercy Livonia Hospital

location_facility: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

location_facility: Saint Joseph Regional Medical Center-Mishawaka

location_facility: Centre Hospitlier Intercommunal de Creteil

location_facility: University Health Network-Princess Margaret Hospital

location_facility: Delaware Clinical and Laboratory Physicians PA

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Clinical Saint-Pierre/Centre Catalan d?Oncologie

location_facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

location_facility: SSM Health Saint Louis University Hospital

location_facility: Cheshire Medical Center-Dartmouth-Hitchcock Keene

location_facility: Franciscan Saint Francis Health-Beech Grove

location_facility: Michiana Hematology Oncology PC-Westville

location_facility: Skagit Regional Health Cancer Care Center

location_facility: ThedaCare Regional Medical Center - Appleton

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Academic Hematology Oncology Specialists

location_facility: Northwestern Medicine Cancer Center Kishwaukee

location_facility: Groupe Hospitalier Public du Sud de l'Oise Senlis

location_facility: Great Plains Health Callahan Cancer Center

location_facility: Genesee Cancer and Blood Disease Treatment Center

location_facility: Northwell Health/Center for Advanced Medicine

location_facility: Faith Regional Health Services Carson Cancer Center

location_facility: Peninsula Cancer Institute-Cancer Specialists of Tidewater

location_facility: Providence Cancer Institute Clackamas Clinic

location_facility: University of Kansas Cancer Center-Overland Park

location_facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

location_facility: Valley Medical Oncology Consultants-Fremont

location_facility: Kootenai Clinic Cancer Services - Post Falls

location_facility: SwedishAmerican Regional Cancer Center/ACT

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Alta Bates Summit Medical Center - Summit Campus

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: MU Health - University Hospital/Ellis Fischel Cancer Center

location_facility: Penn State Health Saint Joseph Medical Center

location_facility: Comprehensive Cancer Centers of Nevada-Summerlin

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Marion L Shepard Cancer Center at Vidant Beaufort Hospital

location_facility: UH Seidman Cancer Center at Southwest General Hospital

location_facility: Ottawa Regional Hospital and Healthcare Center

location_facility: Atrium Health University City/LCI-University

location_facility: Cone Health Cancer Center at Alamance Regional


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions

acronym: PLATINUM

summary:
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.

This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

ReferenceType: result

ReferenceCitation: Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.

ReferenceCitation: Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: hybrid

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

lead_sponsor: Boston Scientific Corporation

location_country:
Finland
Germany
Poland
Portugal
New Zealand
United Kingdom
Singapore
Denmark
Australia
Japan
Netherlands
Austria
Belgium
United States
Latvia
Malaysia
France

location_facility: Ohio Health Research and Innovation Institute

location_facility: Providence Health & Services - Washington

location_facility: St. Luke's Hospital / Mid America Heart Institute

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

location_facility: Cooper Hospital/University Medical Center

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Tokyo Women's Medical University Hospital

location_facility: Southern Illinois University Memorial Medical Center

location_facility: Medical Center of the Rockies (Loveland)

location_facility: Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier

location_facility: University of California Davis Medical Center

location_facility: Saiseikai Yokohama-City Eastern Hospital

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

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

location_facility: Washington University School of Medicine

location_facility: Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases

location_facility: Aspirus Heart and Vascular Institute - Research and Education

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital

location_facility: Jewish Hospital and St. Mary's Healthcare

location_facility: MediQuest Research Group Inc. at Munroe Regional Medical Center

location_facility: Banner Good Samaritan Regional Medical Center

location_facility: Wake Forest University School of Medicine


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and well tolerated.

status: Recruiting

title: A Randomized, Two-arm, Placebo-controlled, Participant, Investigator and Sponsor-blinded, Proof-of-concept Study Investigating the Efficacy, Safety and Tolerability of QUC398 in Patients With Symptomatic Knee Osteoarthritis

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Norway
Denmark
Australia
United States
Spain
France


title: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

acronym: SLEek

summary: The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Canada
France
Colombia
Hungary
United States
China
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634

location_facility: Virginia Mason Medical Center /ID# 211457

location_facility: Chonnam National University Hospital /ID# 211695

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 211829

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 214267

location_facility: Rheumatology Research Unit Sunshine Coast /ID# 211902

location_facility: NYU Langone Orthopedic Center /ID# 213620

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482

location_facility: Hospital Universitario y Politecnico La Fe /ID# 211720

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827

location_facility: EIRAKU Internal Medicine Clinic /ID# 215419

location_facility: Taichung Veterans General Hospital /ID# 211957

location_facility: Valerius Medical Group & Research Center /ID# 211599

location_facility: The Center for Rheumatology and Bone Research /ID# 211610

location_facility: Guangdong Provincial People's Hospital /ID# 211811

location_facility: Arthritis and Rheumatism Associates /ID# 211411

location_facility: NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548

location_facility: Hospital Universitario Virgen de Valme /ID# 212721

location_facility: Xiangya Hospital Central South University /ID# 212919

location_facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 212326

location_facility: Leids Universitair Medisch Centrum /ID# 214413

location_facility: ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063

location_facility: Trinity Universal Research Associates - Carrollton /ID# 211527

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 213846

location_facility: RM Pharma Specialists S.A de C.V. /ID# 211879

location_facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483

location_facility: Deerbrook Medical Associates /ID# 212251

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737

location_facility: Centrum Medyczne Pratia Warszawa /ID# 218176

location_facility: People's Hospital of Xinjiang /ID# 211821

location_facility: KonKuk University Medical Center /ID# 213410

location_facility: Wallace Rheumatic Studies Center, LLC /ID# 211600

location_facility: Taipei Veterans General Hosp /ID# 212216

location_facility: Beth Israel Deaconess Medical Center /ID# 212321

location_facility: St Vincent's Hospital Melbourne /ID# 212311

location_facility: IRIS Research and Development, LLC /ID# 213053

location_facility: Universitaetsklinikum Duesseldorf /ID# 212408

location_facility: Hospital Universitario Basurto /ID# 212722

location_facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861

location_facility: Kumamoto Shinto General Hospital /ID# 215347

location_facility: Seoul National University Hospital /ID# 211740

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685

location_facility: Investigaciones Clinicas Tucuman /ID# 211942

location_facility: Universitair Medisch Centrum Utrecht /ID# 214415

location_facility: Medical Care & Research SA de CV /ID# 212682

location_facility: Accurate Clinical Management /ID# 213571

location_facility: Taipei Medical University Hospital /ID# 221600

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 211719

location_facility: Ohio State University - Wexner Medical Center /ID# 211636

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858

location_facility: University of Colorado Hospital /ID# 211314

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 211895

location_facility: Manchester University NHS Foundation Trust /ID# 211838

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 212796

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145

location_facility: Medstar Health Research Institute /ID# 213335

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 211329

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 214052

location_facility: Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 211894

location_facility: Diex Recherche Sherbrooke Inc. /ID# 217734

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195

location_facility: Centro Integral en Reumatologia S.A de C.V /ID# 211876

location_facility: Aprillus Asistencia e Investigacion /ID# 211630

location_facility: China Medical University Hospital /ID# 212179

location_facility: Hospital Universitario de Galdakao /ID# 212803

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 211931

location_facility: CHU Strasbourg - Hopital Civil /ID# 211981

location_facility: Inland Rheum Clin Trials Inc. /ID# 213617

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 211832

location_facility: National Taiwan University Hospital /ID# 211752

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674

location_facility: Arthritis & Osteo Medical Ctr /ID# 228235

location_facility: Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679

location_facility: East Bay Rheumatology Medical /ID# 211638

location_facility: Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 212042

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770

location_facility: The Queen Elizabeth Hospital /ID# 211901

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988

location_facility: West Broward Rheumatology Associates /ID# 211881

location_facility: Clinica Universitaria Bolivari /ID# 211897

location_facility: Vrije Universiteit Medisch Centrum /ID# 214424

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 213189

location_facility: Fukushima Medical University Hospital /ID# 213913

location_facility: Premier Rheumatology of Oklahoma /ID# 213850

location_facility: Peking Union Medical College Hospital /ID# 211614

location_facility: Centro de Investigaciones Medicas Tucuman /ID# 212714

location_facility: Linkou Chang Gung Memorial Hospital /ID# 211751

location_facility: Rheumatology and Pulmonary Clinic /ID# 211398

location_facility: West Texas Clinical Research /ID# 211529

location_facility: University of Iowa Hospitals and Clinics /ID# 215246

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971

location_facility: Huashan Hospital, Fudan University /ID# 213976

location_facility: The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402

location_facility: Allegheny Health Network Research Institute /ID# 211607

location_facility: St. Josephs Health Care Centre /ID# 212331

location_facility: Royal Brisbane and Women's Hospital /ID# 212667

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146

location_facility: Hospital Universitario 12 de Octubre /ID# 211757

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 212946


acronym: PERUSE

lead_sponsor: Hoffmann-La Roche

summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

ReferenceCitation: Bachelot T, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Bondarenko I, Paluch-Shimon S, Wardley A, Merot JL, du Toit Y, Easton V, Lindegger N, Miles D; PERUSE investigators. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol. 2019 May 1;30(5):766-773. doi: 10.1093/annonc/mdz061.

oa_host_type: publisher

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

location_facility: Hippokratio Hospital; 2Nd Internal Medicine

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Hospital de Barbastro; Servicio de Oncologia

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Hospital Virgen de los Lirios; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Centro Médico Docente La Trinidad; Servicio de Gastroenterología

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: Uni Oncology Inst. ; Chemo - Radiation Dept

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Zaporozhye Regional Oncology Hospital; Dept of Oncology

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: Hospital Quiron Barcelona; Servicio de Oncologia

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Hospital de Cabueñes; Servicio de Oncologia

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Hospital de Sagunto; Servicio de Oncologia

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Hospital Pereira Rossell; Oncology Department

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

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

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Fondazione Del Piemonte; Medical Oncology

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: University Hospital of Larissa; Oncology

location_facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Hameed Latif Hospital; Department of Oncology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Hospital of Patras Medical Oncology

location_facility: Shifa International Hospital; Department of Oncology

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

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: Hospital de Rio Hortega; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

location_facility: Hospital General Universitario de Guadalajara; Servicio de Oncologia

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

location_facility: Gynaekologicum Bremen; Prof. Dr. Willibald Schröder

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Helsinki University Central Hospital; Oncology Clinics

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: King Abdul Aziz Medical City, King Fahd National Guard; Oncology

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Ospedale Maggiore Della Carita; Oncologia Medica

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

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Hopital Prive Drome Ardeche; Hopital De Jour

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

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

location_facility: American University of Beirut - Medical Center

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

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

location_facility: Royal United Hospital; Oncology Department

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Västmanlands sjukhus Västerås, Onkologkliniken

location_facility: Hospital de Basurto; Servicio de Oncologia

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

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Huddersfield Royal Infirmary - Pharmacy department

location_facility: Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

location_facility: Hospital Central De Las FF.AA.; Servicio De Oncologia

location_facility: Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Eastbourne District Hospital; Department of Pharmacy

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

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

location_facility: Southwest Hospital , Third Military Medical University

location_facility: Hospital do Espirito Santo; Servico de Oncologia Medica

title: A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

location_country:
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