title: A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

summary:
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.

The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Hungary
Hong Kong
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Israel

location_facility: Azienda Ospedaliero Universitaria Luigi Vanvitelli

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie

location_facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

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

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE - Hospital de Sao Joao

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD

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

location_facility: Ente Ospedaliero IRCCS Saverio De Bellis

location_facility: Severance Hospital Yonsei University Health System

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

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz

location_facility: Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Presbyterian Intercommunity Hospital Health Whitter Hospital

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera

location_facility: Personal Oncologia de Precisao e Personalizada

location_facility: Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

location_facility: Haematologisch Onkologische Praxis Eppendorf

location_facility: Centre Hospitalier de L Universite de Montreal

location_facility: Lux med onkologia sp zoo szpital szamocka

location_facility: US Oncology Research Investigational Products Center

location_facility: Hospital Haroldo Juacaba - Instituto do Cancer do Ceara

location_facility: Fundacao Antonio Prudente AC Camargo Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

location_facility: Seoul National University Bundang Hospital

location_facility: Regional Kliniken Holding Klinikum Ludwigsburg

location_facility: Fundacao Pio 12 Hospital de Amor de Barretos

location_facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Translational Research in Oncology - US Inc

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Yale New Haven Hospital Yale Cancer Center

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: The Oncology Institute Clinical Research

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing

location_facility: Translational Research in Oncology US Inc, Trio Central Pharmacy

location_facility: Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord

location_facility: Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach

location_facility: United States Oncology Regulatory Affairs Corporate Office


type: Registry Identifier

title: Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Gilead Sciences

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Israel

location_facility: Hospital Clinicl universitario virgen de la Arrixaca

location_facility: Japanese Red Cross Wakayama Medical Center

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil

location_facility: Hospital Regional Universitario de Malaga-Hospital Civil

location_facility: Florida Cancer Specialists (Administration and Drug Shipment)

location_facility: ASST Papa Giovanni XXIII, Oncologia Medica

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie

location_facility: Centor Hospital of the National Center for Global Health and Medicine

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi

location_facility: Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Henry Dunant Hospital Center, 4th Oncology Department

location_facility: Hospital de Clínicas de Porto Alegre - HCPA

location_facility: Kobe City Medical Center General Hospital

location_facility: ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia

location_facility: National Hospital Organization Himeji Medical Center

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

location_facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)

location_facility: Cryptex Investigación Clínica, S.A. de C.V.

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral

location_facility: Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC

location_facility: Required Centre Hospitalier Regional de Rimouski

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica

location_facility: Sunshine Coast University Private Hospital

location_facility: Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals

location_facility: Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle

location_facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Metropolitan General, Oncology department

location_facility: ASST Grande Ospedale Metropolitano Niguarda SC Oncologia

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale

location_facility: Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol

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

location_facility: General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii

location_facility: University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: AOU Policlinico G Rodlico-Oncologia Medica

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Samson Assuta Ashdod University Hospital

location_facility: USOR - Arizona Oncology Associates Tucson - Wilmot

location_facility: Chu Montpellier Hopital Arnaud de Villeneuve

location_facility: Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie

location_facility: Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung

location_facility: Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: University of Wisconsin Clinical Science Center

location_facility: University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

location_facility: Pan American Center For Oncology Trials, LLC

location_facility: Hospital Universitario Fundacion Jimenez Dias

location_facility: University General Hospital of Larissa, Oncology Department-1St Internal Medical Division

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center

location_facility: Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute

location_facility: Froedtert Hospital/Medical College of Wisconsin

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie

location_facility: General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Panamerican Clinical Research S.A. de C.V

location_facility: East Suffolk and North Essex NHS Foundation Trust

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie

location_facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

summary: The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Greece
Israel

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: St. Luke's Cystic Fibrosis Center of Idaho

location_facility: Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

location_facility: General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: Charite Paediatric Pulmonology Department

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Children's Hospital of the King's Daughters

location_facility: Abteilung fuer Pulmologie Klinikum Wels-Grieskirchen

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: University Hospital Limerick (Pediatrics)

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The University of Texas Southwestern Medical Center

location_facility: Schneider Children's Medical Center of Israel

location_facility: University of California Davis Medical Center

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Institute of Tuberculosis and Lung Diseases

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Nemours Children's Specialty Care, Pensacola

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Oklahoma Health Sciences Center

location_facility: CF Therapeutics Development Center of Western New York

location_facility: University of Miami Miller School of Medicine

location_facility: Spectrum Health Medical Group Adult Cystic Fibrosis Care Center

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: University of Utah - Primary Children's Medical Center

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Washington University School of Medicine

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

location_facility: Banner University of Arizona Medical Center

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Centre hospitalier universitaire de Nancy, Hôpital de Braboi

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Lund University Skanes Universitetssjukhus

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Sheba Medical Center - The Edmond and Lili Safra Children's Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Pediatric Hospital Polanki named of Maciej Płażyński

location_facility: Northwell Health- Long Island Jewish Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: University of Mississippi Medical Center

location_facility: Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

location_facility: University Hospital and UW Health Clinics

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: General Hospital of Thessaloniki "Papanikolaou"

status_simplified: Completed


type: Other Identifier

title: Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

acronym: PsABIOnd

summary: The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
Argentina
Australia
Japan
Canada
France
Colombia
Switzerland
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur

location_facility: Evang. Krankenhaus Gemein. Betriebgesm. Mbh

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Hôpital Lariboisière - Centre Viggo Petersen

location_facility: Ospedale Regionale Cardarelli-Università degli Studi del Mol

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: Hippokration General Hospital of Athens, B' Internal Medicine Clinic,

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: NHS Grampian - Aberdeen Royal Infirmary (ARI)

location_facility: Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

location_facility: 'Agios Andreas' General Hospital of Patras

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

location_facility: University General Hospital of Rio Patras

location_facility: Seoul National University Bundang Hospital

location_facility: Akademiskt Specialistcentrum centrum för reumatologi

location_facility: Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

location_facility: Praxis fur Klinische Studien und Praxis fur Orthopadie

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Toho University Medical Center, Ohashi Hospital

location_facility: Centre de Recherche Musculo Squelettique

location_facility: Bakoulev Scientific Center For Cardiovascular Surgery Rams

location_facility: FGBU Research Institute of Rheumatology named V.A.Nasonova

location_facility: Soonchunhyang University Cheonan Hospital

location_facility: Brandusa Florica Medicine Professional Corporation

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: CHR Orléans - Nouvel Hôpital Orléans La Source

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)

summary: Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

ipd_sharing: Yes

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Mauritius
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Iceland
Kenya
India
Romania
Belgium
China
Malaysia
Estonia
Puerto Rico
Philippines
Italy
Norway
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Stanford University Medical Center School of Medicine

location_facility: Wake Forest U of Health Sciences-Cardiology Dept

location_facility: Adventist HealthCare Shady Grove Medical Center

location_facility: Advanced Research for Health Improvement LLC

location_facility: The Heart Group Cardiovascular Associates Inc

location_facility: University of Florida - Shands Jacksonville UF Health Jacksonville

location_facility: Cardiovascular and Vein Center of Florida

location_facility: Cardiovascular Institute of the South Dept of Cardiovascular Inst

location_facility: Cardiovascular Research Of Northwest Indiana, Llc

location_facility: North Shore Diabetes and Endocrine Associates

location_facility: Akron Hospital Summa Health System Akron Hospital

location_facility: Methodist Physicians Clinic Heart Consultants

location_facility: MidMichigan Medical Center Midland Main Center

location_facility: Alaska Cardiology Reserach Foundation, NFP

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Apex Cardiology Research Associates of Jackson

location_facility: Metro Health Univ of MI Health Metro Health U Of Mi Health

location_facility: Clinical Trials Management, LLC Clinical Trials Mgmt-Covington

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Emerson Clinical Research Institute, LLC

location_facility: University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland

location_facility: Novant Health Heart and Vascular Institute

location_facility: Ponce Medical School Foundation Inc Centro Med Episcopal San Lucas

location_facility: North Memorial Heart and Vascular Institute

location_facility: Albany Medical College Div of Community Endocrinology

location_facility: Cardiovascular Associates Research Main Center


title: A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

summary:
This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).

The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

ReferenceType: derived

ReferenceCitation: Cheminant M, Lhermitte L, Bruneau J, Sicard H, Bonnafous C, Touzart A, Bourbon E, Ortonne N, Genestier L, Gaulard P, Palmic P, Suarez F, Frenzel L, Naveau L, Bazarbachi A, Dussiot M, Waast L, Avettand-Fenoel V, Brouzes C, Pique C, Lepelletier Y, Asnafi V, Marcais A, Hermine O. KIR3DL2 contributes to the typing of acute adult T-cell leukemia and is a potential therapeutic target. Blood. 2022 Sep 29;140(13):1522-1532. doi: 10.1182/blood.2022016765.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Germany Spain Belgium France

location_facility: Cliniques universitaires Saint-Luc - Université catholique de Louvain

location_facility: CH de Bretagne Atlantique - Hopital Chubert

location_facility: UNIVERSITAT LEIPZIG - Klinik fur Hamatologie, Zelltherapie und Hamostaseo

location_facility: CHU de Dijon BOURGOGNE - Hôpital François Mitterand

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: HELORA - Hôpital de La LouvièreSite Jolimont

location_facility: Hospital Universitario Fundacion Jimenez Diaz - Hematologia

location_facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme

location_facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

location_facility: GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizini

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CH de la Côte Basque - Hôpital de Bayonne


acronym: WAYFIND

summary: The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.

sponsor_collaborators:
Gilead Sciences
Novo Nordisk A/S

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of Alabama at Birmingham Hospital

location_facility: The Institute for Liver Health DBA Arizona Liver Health

location_facility: Clinical Research Institute of Ohio, LLC

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Yale Center for Clinical Investigation, Church Street Research Unit

location_facility: Velocity Clinical Research, Salt Lake City

location_facility: Schiff Center for Liver Diseases/ University of Miami

location_facility: Allied Health Clinical Research Organization, LLC

location_facility: Tulane University Health Sciences Center

location_facility: Gastrointestinal (GI) Specialists of Georgia

location_facility: Michigan Medicine - University of Michigan

location_facility: Monash Health, Monash Medical Centre (Clayton)

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: University of Florida Hepatology Research at the Clinical and Translational Research Building

location_facility: Digestive Health Research of Southern California

location_facility: Toronto Digestive Disease Associates Specialty Research

location_facility: Diabetes and Glandular Disease Clinic, P.A.

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond

location_facility: Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: Walter Reed National Military Medical Center

location_facility: Center for Research at Southwest Gastroenterology Associates, PC

location_facility: Wlliam Osler Health System - Brampton Civic Hospital

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: University of California, San Francisco - Liver Clinic

location_facility: Atrium Health Transplant and Center for Liver Disease

location_facility: Indiana University Health Enterprise Clinical Research Operations

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi

location_facility: Gastrointestinal Associates of Northeast Tennessee

location_facility: Northwell Health Center for Liver Diseases

location_facility: University of California, San Diego - Altman Clinical and Translational Research Institute

location_facility: Asheville Gastroenterology, a Division of Digestive Health Partners, PA

location_facility: Hospital Universitario La Paz Edificio de Malemidad

location_facility: Hospital Clinico Universitario de Santiago

location_facility: The Institution For Liver Health dba Arizona Liver Health

location_facility: Virginia Commonwealth University Health Clinical Research Services Unit

location_facility: Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of California, Davis Medical Center

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Hospital General Universiatrio Gregorio Maranon

location_facility: The University Of Vermont Medical Center

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: Keck Medical Center of USC Healthcare Consultation II

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: International Medical Investigational Centers, Inc.

location_facility: Toronto General Hospital - University Health Network

location_facility: Rush University Medical Group - Department of Hepatology

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Nice - Hopital L'archet

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic

location_facility: Internal Medicine Digestive and Liver Diseases Clinical Trials

location_facility: Encore Borland-Groover Clinical Research

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

location_facility: Hospital Universitario y Politecnlo la Fe

location_facility: GI Alliance (Patients Seen, IP Shipment & Fibroscan)

location_facility: London Health Sciences Centre - University Hospital

location_facility: DHR Health Institute for Research and Development Cancer Research Center

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: (G.I.R.I.) Gastrointestinal Research Institute

location_facility: Digestive Health Research of North Texas

location_facility: University of California, San Francisco - Fresno

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital

title: A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

source: euctr

location_country:
Australia
Japan
United States
Spain
Canada
Puerto Rico
France


title: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

summary: The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Australia
Japan
Turkey
Canada
France
Portugal
Slovakia
Hungary
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

summary:
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

ipd_sharing_description:
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Costa Rica
Japan
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
Latvia
Kenya
Ukraine
Uganda
North Macedonia
India
Romania
Belgium
China
Malaysia
Peru
Egypt
Philippines
Italy
Guatemala
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Israel

location_facility: UPMC Western Maryland - Schwab Family Cancer Center

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Praxis fuer gynaekologische onkologie Prof. Dr. me

location_facility: CBCC Global Research Inc., at Comprehensive Blood and Cancer Center

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

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

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Oncologia S.A.C. - Instituto Peruano de Oncología & Radioterapia

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Investigación Médica de Alta Especialidad

location_facility: East Avenue Medical Center; Breast Care Center

location_facility: North Coast Cancer Institute - Port Macquarie

location_facility: Stamford Hospital; Clincal Trials Office - 1st Fl - Bennett Cancer Cente

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

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics

location_facility: Kailash Cancer Hospital and Research Center

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Metropolitan Hospital First Oncology Clinic

location_facility: Office of Alma Magdalena Astorga-Ramos, MD

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

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

location_facility: Fundacion Arturo Lopez Perez; Quimioterapia

location_facility: Southern Cross Research South Africa (PTY) LTD

location_facility: Excellentis Clinical Trial Consultants; Clinical Research

location_facility: Clinica Universidad Navarra; Servicio de Farmacia

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Ac?badem Adana Hospital, Oncology Department

location_facility: Shalinitai Meghe Medical College and Hospital

location_facility: Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre

location_facility: Cleveland Clinic; Taussig Cancer Institute

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: PHI Clinical Hospital Dr Trifun Panovski Bitola

location_facility: Cardinal Santos Medical Center; Department of Internal Medicine, Section of Endocrinology

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

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

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Harbin Medical University Cancer Hospital

location_facility: Wenzhou Medical College - The First Affiliated Hospital GCP

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzia? Onkologii Klinicznej

location_facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

location_facility: Centro Odonito Medico Linus Pauling - Clinica de O

location_facility: Liverpool Hospital; Cancer Therapy Centre

location_facility: General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

location_facility: Pamela Youde Nethersole Eastern Hospital; Department Of Pediatrics

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Chopda Medicare & Research Centre pvt. Ltd

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: Massachusetts General Hospital; Lurie Center for Autism

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Hospital HM Nuestra Señora de la Esperanza

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

location_facility: Complex Oncology Center Burgas; Medical Oncology Department

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Kinghorn Cancer Centre; Pharmacy Department

location_facility: National Hospital Organization Osaka National Hospital

location_facility: University of Missouri-Columbia; Ellis Fischel Cancer Center

location_facility: Narodowy Instytut Onkologii im. M.Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Oddzia? Gliwice

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Instituto de Investigaciones Metabólicas (IDIM); Diabetes

location_facility: Sujan Surgical Cancer Hospital And Amravati Cancer Foundation

location_facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología

location_facility: Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

location_facility: Hospital de Clinicas de Porto Alegre HCPA PPDS

location_facility: Consultorio Oncologico-Hospital Metropolitano San

location_facility: Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology

location_facility: A.ö. Krankenhaus der Barmherzigen Brüder

location_facility: Shengjing Hospital of China Medical University

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Valley Breast Care and Women's Health Center

location_facility: ALEXANDRIA UNI; Clinical Research Center

location_facility: Saint Louis University Hospital of Sacred Heart

location_facility: Praxis fur Haematologie und Internistische Onkologie

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: Instituto de Oncologia Clínica de Piracicaba

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: Himalaya Cancer Hospital & Research Institute

location_facility: General Hospital Djordje Joanovic - Zrenjanin

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: University of Florida; UF Health Shands Cancer Hospital

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

location_facility: Clinical Center University of Sarajevo; Oncology Institute

location_facility: Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Air Force Military Medical University Xijing Hospital

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Kantonsspital Winterthur Medizin Pneumologie

location_facility: Rocky Mountain Cancer Centers (Longmont) - USOR

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

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

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

location_facility: KLES Dr Prabhakar Kore Hospital and Medical Research Centre

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Stefanie Spielman Comprehensive Breast Center

location_facility: Centro Oncologioco MD Anderson Internacional; Servicio de Farmacia

location_facility: Medical Technology Center for Research and Services

location_facility: Centro de Oncologia da Bahia; Centro Médico Iguatemi

location_facility: Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Hämatologie und Onkologie Ravensburg / Wangen

location_facility: University of Athens Medical School - Regional General Hospital Alexandra

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay Lac Saint Jean

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: UPMC Williamsport, Divine Providence Campus

location_facility: Spital STS AG Thun - Berner Oberland ; Onkologie Zentrum

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Xiangya Hospital Central South University

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: Fondazione Policlinico Universitario A Gemelli; Farmacia Interna

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Kiran Hospital Multi Super Speciality Hospital and Research Center

location_facility: Centro de Investigación Clínica ? Clínica Viedma

location_facility: Soon Chun Hyang University Cheonan Hospital

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

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Regional Municipal Non-Commercial Enterprise Bukovynian Clinical Oncology Center

location_facility: Luzerner Kantonsspital LUKS; Studienzentrale Onkologie

location_facility: SI Institute for general and urgent surgery n.a. V.T.Zaitseva of NAMS of Ukraine

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: University Hospitals Cleveland Medical Center

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: University of Santo Tomas Hospital; Pharmacy

location_facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Hirslanden Klinik St. Anna Brustzentrum/Chirurgie

location_facility: Westmead Hospital; Pharmacy Distribution Centre

location_facility: Sociedad de Oncología y hematología del Cesar Ltda

location_facility: Gynäkologisch Onkologische Praxis Hannover

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Klinik Arast?rma Merkezi

location_facility: Penn State Univ. Milton S. Hershey Medical Center; Department of Investigational Drug Services

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Spitalul Clinic de Obstetrica si Ginecologie Filantropia; Sectorul 1 BUCURE?TI

location_facility: SRH Wald-Klinikum Gera; Brustzentrum Ostthüringen

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: State Cancer Institute, Indira Gandhi Institute of Medical Sciences (IGIMS)

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Complejo Hospitalario de Navarra; Servicio de Farmacia

location_facility: Consultorio Oncologico-Hospital Metropolitano Linc

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Facharztpraxis für Gynäkologie und Geburtshilfe PD Dr. med. Christian Kurbacher

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Centro de Investigación en Artritis y Osteoporosis - PPDS

location_facility: Guangdong Provincial Maternity and Child Care Cent

location_facility: University of Maryland; St. Joseph Medical Center

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Hemato Oncology Clinic Ahmedabad Pvt Ltd

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

location_facility: Torrance Memorial Physician Network/Cancer Care

location_facility: Hospital Universitario Juan Ramon Jimenez

location_facility: IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Centre Hospitalier Departemental de Vendee

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

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Universidade de Caxias do Sul - Rio Grande do Sul

location_facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM

location_facility: Hospital Senhora da Oliveira ? Guimaraes, E.P.E

location_facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

location_facility: Centro Hospitalar Trás Os Montes E Alto Douro EPE

location_facility: Baylor College of Medicine Medical Center

location_facility: University College London Hospitals; Clinical Research Facility

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Instituto de Investigación en Ciencias Médicas S.A.

location_facility: Lokmanya Holistic Cancer Care and Research Center (LMRC)

location_facility: Memorial Health University Cancer Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Farmacia

location_facility: Kasr Al Ainy School of Medicine-Cairo University

location_facility: Clínica Integral Internacional de Oncología S de RL de CV

location_facility: Virginia Commonwealth University - Massey Cancer Center

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

location_facility: Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi

location_facility: Institute Jules Bordet; Med Onc & Translational Rsch

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: All India Institute of Medical Sciences, Bhubaneswar

location_facility: Timisoara Emergency County Clinical Hospital

location_facility: USOR - Texas Oncology - San Antonio Northeast

location_facility: Social Medical Corporation Hakuaikai Sagara Hospital

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Clínica Médica Especializada en Hematología

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Szpital Morski Im. Pck; Oncology & Radiotherapy Dept

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Hospital Nossa Senhora da Conceição; Ambulatório de Pneumologia

location_facility: Sandton Oncology Medical Group (Pty) Ltd

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Hospital Universitario HM Sanchinarro ? CIOCC; Farmacia - Ensayos Clínicos

location_facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

location_facility: Hsin-Chu Branch of National Taiwan University Hospital

location_facility: Centro Medico Integral de Cancerologia CEMIC

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Metropolitan Hospital Fourth Oncology Clinic

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital General Universitario de Alicante

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Universitätsspital Bern; Departement Herz & Gefässe

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Seoul National University Bundang Hospital

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre; Hospital Dom Vicente Scherer

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

location_facility: Pauls Stradins Clinical University Hospital

location_facility: GZA Ziekenhuizen Antwerpen campus Sint-Augustinus

location_facility: Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie

location_facility: Univerzitna nemocnica s poliklinikou Milosrdni bratia spol s r o

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Second People's Hospital of Neijiang

location_facility: Ltd Israel-Georgia Medical Research Clinic Helsicore

location_facility: University General Hospital of Heraklion

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Baguio General Hospital and Medical Center

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: University of Pittsburgh Medical Center; Division of Hematology-Oncology

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Christian Medical College-Ranipet Campus

location_facility: Communal Non-Profit Enterprise Chernihiv Medical Center of Modern Oncology of CRC

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Oncoclinicas do Brasil Servicos Medicos As

location_facility: University of Kentucky; Markey Cancer Center

location_facility: Hämatologisch/onkologische Gemeinschaftspraxis; Dres. Brudler/Heinrich/Bangerter


title: A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

acronym: VOLGA

summary:
A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).

Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.

In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Vietnam
Turkey
Chile
Canada
Serbia
France
Colombia
Portugal
Hong Kong
United States
Ukraine
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity

acronym: DIRECTION

summary: This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

ReferenceCitation: Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
United States
Canada
Puerto Rico
France

location_facility: Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonction

location_facility: Parkinson's Disease Treatment Center of S.W. Florida

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Parkinson's & Movement Disorders Institute

location_facility: Centre Hospitalier de Saint Amand Montrond

location_facility: UMass Memorial Medical Center - University Campus

location_facility: University of South Florida Health-Morsani Center for Advanced Healthcare

location_facility: Siskin Hospital for Rehabilitation - Neurology

location_facility: HonorHealth Scottsdale Osborn Medical Center

location_facility: Penn State Health Physical Medicine and Rehabilitation - Neurology

location_facility: Texas Institute for Neurological Disorders

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Cleveland Clinic - Neurological Institute

location_facility: Rehabilitation Associates of the Main Line

location_facility: North Texas Institute of Neurology & Headache

location_facility: Virginia Tech - Carilion School of Medicine

location_facility: Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

location_facility: Centre Hospitalier de Saint-Amand-les-Eaux

location_facility: Hopital Albert Chennevier (CHU Henri Mondor)

location_facility: Weill Cornell Medicine Clinical and Translational Science Center

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Carilion Clinic Institute of Orthopaedics and Neurosciences

location_facility: Hotel Dieu Shaver Health And Rehabilitation Centre

location_facility: Ki Health Partners LLC D/B/A New England Institute for Clinical Research

intervention_type: Biological


title: A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

summary: This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

lead_sponsor: Nanobiotix

location_country:
Finland
Germany
Japan
Czechia
Canada
Serbia
France
Portugal
Hungary
United States
Romania
Belgium
China
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Georgia
Israel

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: Centre Hospitalier Regional Universitaire Brest

location_facility: Ambroise Paré Clinic Group - Hartmann Clinic

location_facility: National Cheng Kung University (NCKU) Hospital

location_facility: Severance Hospital Yonsei University Health System

location_facility: University Specialized Hospital for Active Treatment in Oncology EAD

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

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Multi-profile Hospital for Active Treatment Uni Hospital

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Centre de Lutte contre le Cancer - Centre Oscar Lambret

location_facility: Evex Hospitals - Kutaisi Referral Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of North Carolina at Chapel Hill

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Lee Moffitt Cancer Center and Research Institute

location_facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Affiliated Hospital of Xuzhou Medical University

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Rechts der Isar Hospital of the Technical University of Munich

location_facility: Guangxi Medical University Affiliated Wuming Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital


title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)

acronym: UPSTAND

summary:
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.

Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_country:
Poland
Bulgaria
Hungary
Argentina
Israel
Australia
Kuwait
Switzerland
Mexico
Belgium
United Arab Emirates
Spain
Greece
Canada
Russian Federation
France

location_facility: Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213

location_facility: Complejo Hospitalario Universitario de Santiago /ID# 249025

location_facility: Hospital Universitario Canarias /ID# 249043

location_facility: Chelyabinsk Regional Clinical Hospital /ID# 244741

location_facility: Paratus Clinical Research Woden /ID# 231460

location_facility: KAT Atttica General Hospital /ID# 243063

location_facility: Nebbiolo Clinical Research Center /ID# 231167

location_facility: Hospital Virgen de la Concha /ID# 249026

location_facility: CHU Lille - Hôpital Roger Salengro /ID# 228820

location_facility: AP-HP - Hopital Saint-Antoine /ID# 228795

location_facility: Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765

location_facility: "Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791

location_facility: CHR Orleans - Hopital de la Source /ID# 234258

location_facility: Hospital Universitario Son Llàtzer /ID# 249032

location_facility: CHU Amiens-Picardie Site Sud /ID# 228821

location_facility: Hospital Universitario 12 de Octubre /ID# 249033

location_facility: Republican hospital named after V.A. Baranov /ID# 231173

location_facility: Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509

location_facility: GBUZ RM "Mordovia Republican Central Clinical Hospital" /ID# 244738

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 241111

location_facility: Hospital Universitario Virgen Macarena /ID# 249039

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228829

location_facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940

location_facility: Complejos Hospitalario Universitario de Badajoz /ID# 249036

location_facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479

location_facility: University General Hospital of Patras /ID# 243795

location_facility: Hospital Universitario Virgen del Rocio /ID# 249038

location_facility: GH Diaconesses Croix Saint-Simon /ID# 238548

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 239936

location_facility: CHU de Besancon - Jean Minjoz /ID# 242499

location_facility: CHU Toulouse - Hopital Purpan /ID# 228818

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228836

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042

location_facility: Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092

location_facility: CHU Grenoble - Hopital Michallon /ID# 228792

location_facility: Hospital Universitario Ramon y Cajal /ID# 249035

location_facility: Yaroslavl State Medicat University /ID# 231168

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 240980

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 243796

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947

location_facility: Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435

location_facility: Arthur Karasik Medicine Professional Corporation /ID# 241932

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938

location_facility: The Chaim Sheba Medical Center /ID# 241305

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933

location_facility: Hospital Universitario Torrecardenas /ID# 252804

location_facility: General Hospital of Athens Laiko /ID# 241128

location_facility: The Baruch Padeh Medical Center Poriya /ID# 249797

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937

location_facility: CHU de Besancon - Jean Minjoz /ID# 230528

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939

location_facility: 424 General MILITARY Hospital /ID# 241127

location_facility: Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra "Surgut Dist /ID# 242369

location_facility: Clinic of Samara State Medical University /ID# 241166

location_facility: CHU de Rennes - Hospital Sud /ID# 228842

location_facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 246284

location_facility: Hospital Clinico Universitario de Valladolid /ID# 252001

location_facility: Orenburg State Medical University /ID# 233183

location_facility: Royal Prince Alfred Hospital /ID# 232417

location_facility: Regional Clinical Hospital of Kaliningrad region /ID# 238475

location_facility: Hospital Universitario Lucus Augusti /ID# 255820

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 231440

location_facility: Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232

location_facility: Euromedica Blue Cross Gen Clin /ID# 244945

location_facility: Military Medical Academy n.a. Kirov /ID# 242363

location_facility: Hospital Universitario Nuestra Señora de Candelaria /ID# 249044

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 231172

location_facility: "Prof. Anastas Batalov AIPSMP-VBR" EOOD /ID# 249788

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 238961

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 230548

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 241124

location_facility: Lau Bacchus Professional Medicine Corp /ID# 242591

location_facility: The Lady Davis Carmel Medical Center /ID# 241867

location_facility: ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789

location_facility: Hospital Universitario de Jaen /ID# 249041

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225

location_facility: Barwon Rheumatology Services /ID# 230068

location_facility: Tel Aviv Sourasky Medical Center /ID# 241864

location_facility: ChUZ Clinical Hospital RZD-Medicine /ID# 233185

location_facility: Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823

location_facility: General Hospital of Athens Ippokratio /ID# 241133

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 238334

location_facility: Hospital Universitario Mutua Terrassa /ID# 249031

location_facility: Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 249030

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 231171


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

acronym: frontMIND

summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

lead_sponsor: MorphoSys AG

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Thailand
Turkey
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hungary
United States
Ukraine
Romania
Malaysia
Philippines
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility:
Morphsys Research Site
Morphosys research site
MorphoSys Research Site
Morphosys Research Site


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome (SELECT MDS-1)

summary: This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.

lead_sponsor: Syros Pharmaceuticals

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Austria
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Western General Hospital in NHS Lothian Edinburgh Scotland

location_facility: Ospedali Marche Nord Centro Ematologia e Trapianti

location_facility: Morristown Medical Center- Atlantic Hematology Oncology

location_facility: Fakultni nemocnice Olomouc (University Hospital Olomouc)

location_facility: Hospital Universitario Central de Asturia

location_facility: American Oncology Partners of Maryland, PA

location_facility: SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)

location_facility: Montefiore Medical Center & Albert Einstein College of Medicine

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Centre Hospitalier de la Côte Basque Hématologie Clinique

location_facility: Sandwell and West Birmingham Hospital NHS Trust

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: CHU Grenoble Alpes Hôpital Nord Michallon

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Novant Health Cancer Institute - Forsyth

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Hospital del Mar Secretaria d'Hematologia Clínica

location_facility: Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Markhot Ferenc Oktatókórház és Rendelőintézet, Belgyógyászati- és Infektológiai Centrum

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Debrecen University Medical and Health Science Centre

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Salzburg Cancer Research Institute (SCRI)

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_facility: Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona


title: An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

acronym: SOTERIA

summary:
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.

The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Czechia
Canada
Serbia
France
Colombia
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
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Netherlands
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Mexico
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location_facility: Instituto Medico Rio Cuarto ( Site 1907)

location_facility: Aarhus Universitetshospital, Skejby ( Site 3801)

location_facility: Kaohsiung Veterans General Hospital ( Site 3702)

location_facility: Hospital Dr. Jose Maria Cullen ( Site 1902)

location_facility: David Geffen School of Medicine at UCLA ( Site 1068)

location_facility: Cleveland Clinic Foundation ( Site 1065)

location_facility: Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)

location_facility: University of Nebraska Medical Center ( Site 1053)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Maastricht University Medical Center ( Site 2603)

location_facility: Onassis Cardiac Surgery Center ( Site 3602)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)

location_facility: Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)

location_facility: Gachon University Gil Medical Center ( Site 3103)

location_facility: Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)

location_facility: Medizinische Universitat Innsbruck ( Site 2004)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

location_facility: Institute of Cardiovascular Diseases Dedinje ( Site 2903)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: Universitaetsklinik Regensburg ( Site 1503)

location_facility: The Catholic University Seoul St. Mary's Hospital ( Site 3104)

location_facility: The George Washington University Medical Faculty Associates ( Site 1025)

location_facility: Norrlands Universitetssjukhus ( Site 3205)

location_facility: Royal Free London NHS Foundation Trust ( Site 1202)

location_facility: Hospital Clinic de Barcelona ( Site 1602)

location_facility: UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 3201)

location_facility: Seoul National University Hospital ( Site 3102)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: China Medical University Hospital ( Site 3701)

location_facility: Centro Oncologico de Rosario ( Site 1905)

location_facility: Sir Mortimer B Davis Jewish General Hospital ( Site 2103)

location_facility: University of Rochester Medical Center - PPDS ( Site 1039)

location_facility: St Boniface General Hospital ( Site 2106)

location_facility: Universita "La Sapienza" Policlinico Umberto I ( Site 2402)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 3601)

location_facility: The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 3404)

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)

location_facility: University of Iowa Hospital and Clinics ( Site 1050)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)

location_facility: Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)

location_facility: Medical University of South Carolina - PPDS ( Site 1003)

location_facility: University of California San Francisco ( Site 1019)

location_facility: Universataet des Saarlandes ( Site 1513)

location_facility: Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)

location_facility: University of Texas Southwestern Medical Center ( Site 1038)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1609)

location_facility: University of Washington Medical Center ( Site 1067)

location_facility: University of New Mexico Health Sciences Center ( Site 1048)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)

location_facility: The Ohio State University Wexner Medical Center ( Site 1032)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1601)

location_facility: Duke University Medical Center ( Site 1026)

location_facility: The Prince Charles Hospital ( Site 1104)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: University of South Florida ( Site 1043)

location_facility: Renown Regional Medical Center ( Site 1055)

location_facility: University of Alberta Hospital ( Site 2101)

location_facility: Hospital Universitario de Toledo ( Site 1607)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1605)

location_facility: Hospital Universitario de Son Espases ( Site 1611)

location_facility: Klinički Bolnički Centar Split ( Site 3901)

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3902)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

location_facility: Hospital Universitario La Paz ( Site 1610)

location_facility: Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)

location_facility: Hospital Provincial del Centenario ( Site 1912)

location_facility: Mayo Clinic Jacksonville - PPDS ( Site 1045)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 1401)

location_facility: Golden Jubilee National Hospital ( Site 1204)

location_facility: Hopital Civil - CHU Strasbourg ( Site 1307)

location_facility: Norton Pulmonary Specialists ( Site 1066)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: Hospital São Lucas da PUCRS ( Site 1801)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: Medizinische Universitat Wien ( Site 2001)

location_facility: University Clinical Center Nis ( Site 2904)

location_facility: Assuta Ashdod Medical Center ( Site 1710)

location_facility: Medizinische Universität Graz ( Site 2003)

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)

location_facility: Instituto do Coracao - HCFMUSP ( Site 1803)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: St. Joseph's Healthcare Hamilton ( Site 2105)

location_facility: Instituto Cardiovascular de Rosario ( Site 1906)

location_facility: University of Cincinnati Medical Center ( Site 1035)

location_facility: Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)

location_facility: National Cheng Kung University Hospital ( Site 3703)

location_facility: Chonnam National University Hospital ( Site 3105)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)

location_facility: University of California Irvine ( Site 1086)

location_facility: The University of North Carolina at Chapel Hill ( Site 1042)

location_facility: The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)

location_facility: Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)

location_facility: Skanes Universitetssjukhus Lund ( Site 3203)

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)

location_facility: Radboud University Nijmegen Medical Centre ( Site 2605)

location_facility: Jeffrey S.Sager MD Medical Corporation ( Site 1060)

location_facility: Universitatsklinikum Leipzig ( Site 1508)

location_facility: Fundacion Neumologica Colombiana ( Site 3403)

location_facility: Tufts Medical Center - PPDS ( Site 1012)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: Attikon University General Hospital of Athens ( Site 3604)

location_facility: Waikato District Health Board ( Site 2702)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

location_facility: CHU de la Miletrie Poitiers ( Site 1316)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)

location_facility: Evangelismos General Hospital of Athens ( Site 3605)

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)

location_facility: University of California San Diego ( Site 1002)

location_facility: Centro Hospitalar E Universitário De Coimbra ( Site 3502)

location_facility: C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)

location_facility: Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

location_facility: Saint Vincents Hospital Sydney ( Site 1102)

location_facility: Institute for pulmonary diseases of Vojvodina ( Site 2906)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)