lead_sponsor: BeiGene

summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

ReferenceCitation: Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.

location_facility: Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio

location_facility: The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Rostov Research Institute of Oncology (RRIO)

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The Fifth Medical Center of Chinese PLA General Hospital

location_facility: Guangdong Province Traditional Chinese Medical Hospital

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Cancer Hospital of Guangxi Medical University

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Smilow Cancer Hospital at Yale-New Haven - Neurology

location_facility: Quanzhou First Hospital - Radiotherapy/Nuclear Medicine

location_facility: SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin

location_facility: Gachon University Gil Medical Center - Oncology

location_facility: Chi Mei Medical Center - YongKang - Chi Mei Medical Center

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre

location_facility: China Medical University Hospital - Oncology - Taichung

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Beatson West of Scotland Cancer Centre - Oncology

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Medical University of South Carolina Hollings Cancer Center

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

location_facility: Arkhangelsk Regional Clinical Oncological Dispensary

location_facility: Affiliated Hospital of Jiangnan University

location_facility: National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology

location_facility: Shandong Cancer Hospital and Institute, Shandong First Medical University

location_facility: Royal Marsden NHS Foundation Trust Sutton

location_facility: Chi Mei Hospital, Liouying - Department of Oncology

location_facility: Keimyung University Dongsan Medical Center

location_facility: University of Texas Health Science Center of San Antonio

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

location_facility: The First Affiliated Hospital of Xiamen University - Oncology

location_facility: Kansai Rosai Hospital - Gastroenterological Surgery

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

location_facility: CHA Bundang Medical Center, CHA University - Oncology

location_facility: Orenburg Regional Clinical Oncology Center

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

location_facility: Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic

location_facility: SMG-SNU Boramae Medical Center - Oncology

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: Kobe City Medical Center General Hospital - Medical Oncology

location_facility: Sir Run Run Shaw Hospital, Zhejiang University

location_facility: National Cancer Center Hospital East - Gastrointestinal Oncology

location_facility: Osaka University Hospital - Medical Oncology

location_facility: Peking Union Medical College Hospital - Oncology

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: Hiroshima University Hospital - Gastrointestinal Surgery

location_facility: Ballarat Oncology & Haematology Services

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: The Sixth Affiliated Hospital of Sun Yat-Sen University

location_facility: Fujian Provincial Cancer Hospital - Oncology

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Kaohsiung Veterans General Hospital - Thoracic Surgery

location_facility: The Christie NHS Foundation Trust - Oak Road Treatment Centr

location_facility: The First People's Hospital of Changzhou - Oncology

location_facility: The Affiliated Hospital of Xuzhou Medical University - Radiology

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Saitama Cancer Center - Gastroenterology

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Hospital Universitario Central de Asturias

location_facility: Seoul National University Bundang Hospital - Hematology/Oncology

location_facility: Groupe Hospitalier Paris Saint Joseph - Oncologie

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie

location_facility: Kyushu Medical Center - Gastroenterological Surgery

location_facility: National Cancer Center Hospital - Gastrointestinal Oncology

location_facility: The First Affiliated Hospital of Zhengzhou University - Oncology

location_facility: Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie

location_facility: Kanagawa Cancer Center - Gastroenterological surgery

location_facility: Korea University Guro Hospital - Hematology-Oncology

location_facility: Anhui Medical University - The Second Hospital

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Centre Hospitalier Universitaire de Poitiers

title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

location_country:
Germany
Italy
Poland
United Kingdom
Romania
Australia
Japan
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Russian Federation
France


study_start_date_type: Actual

acronym: PROTEUS

intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

ReferenceType: derived

ReferenceCitation: Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Universitatsklinikum Schleswig Holstein Campus Lubeck

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy

location_facility: CHUM - Centre hospitalier universitaire de Montreal

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital)

location_facility: Kobe City Medical Center General Hospital

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia

location_facility: Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: CAMC Memorial Hospital, Charleston Area Medical Center Physicians

location_facility: Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Fakultni nemocnice Plzen, Urologicka klinika

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Praxisgemeinschaft f. Onkologie u. Urologie - Germany

location_facility: ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

location_facility: Kliniken Nordoberpfalz, Klinik für Urologie

location_facility: CHU de Quebec-Universite Laval-Hopital de l'Enfant-Jesus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Great Lakes Physician PC d/b/a Western New York Urology Associates

location_facility: Ochsner LSU Health Shreveport - Regional Urology

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Seoul National University Bundang Hospital

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Emory University - Winship Cancer Institute

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

location_facility: Mayo Clinic - Division Of Hematology/oncology

location_facility: Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

status: Active, not recruiting

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

type: Registry Identifier

source: euctr

enrollment_type: Actual

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Australia
Brazil
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: MAGNITUDE

summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie

location_facility: Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital)

location_facility: Southern Alberta Institute of Urology / Prostate Cancer Centre

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Pyatigorsk Interdistrict Oncology Dispensary

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fakultni nemocnice Plzen, Urologicka klinika

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma

location_facility: Clinical Diagnostic Centre of Nizhny Novgorod Region

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Guangzhou First Municipal People's Hospital

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: Fujian Medical University Union Hospital

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Thomayerova nemocnice, Onkologicka klinika

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Cukurova University, Faculty of Medicine

location_facility: Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Drug clinical trial ethics committee of Ningbo First Hospital

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Southwest Hospital, The Third Military Medical University

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Beijing Cancer Hospital of Peking University

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: A.O.U. Città della Salute e della Scienza

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

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: MC Haaglanden Lok Antoniushove - Afd.Interne - INT

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Specialized Hospital for Active Treatment in Oncology EAD

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Oncologia Medica A - Ist Naz Tumori G Pascale

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

location_facility: Private Medical Institution Euromedservice

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: University of Florida Health Jacksonville

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Tianjin Medical University Cancer Hospital

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: State Institution National Cancer Institute

title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: DUO-O

lead_sponsor: AstraZeneca

summary: This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

sponsor_collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

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:
Finland
Germany
Poland
Japan
Brazil
Turkey
Canada
France
Hungary
Denmark
United States
Romania
Belgium
China
Peru
Italy
Austria
Korea, Republic of
Spain
Bulgaria


title: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

summary: Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

status: Enrolling by invitation

enrollment_type: Anticipated

lead_sponsor: United Therapeutics

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Portugal
Hungary
Denmark
United States
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

location_facility: University Health Network-Toronto General Hospital

location_facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

location_facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: The Ohio State University Wexner Medical Center

location_facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

location_facility: The Lady Davis Carmel Medical Center, 7 Michal st.

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

location_facility: Xiangya Hospital Central South University

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

location_facility: University of Cincinnati-Medical Science Building

location_facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital

location_facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.

location_facility: Medical College of Wisconsin/Froedtert Hospital

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Balcalı, Çukurova Üniversitesi Kardiyoloji ABD

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

location_facility: Centro Hospitalar de Santo António, E.P.E.

location_facility: University of California Davis Medical Center

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

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

location_facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

location_facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

location_facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

location_facility: UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

location_facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Hospital Clinic de Barcelona, C/ Villarroel, 170

location_facility: Carilion Clinic Pulmonary and Sleep Medicine

location_facility: Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü

location_facility: Washington University School of Medicine

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

location_facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

location_facility: Gachon University Hospital Gil Medical Center

location_facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

location_facility: The Methodist Hospital Research Institute

location_facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

location_facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

location_facility: Royal Free London NHS Foundation Trust, Pond Street

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

location_facility: Gazi University Medical Faculty Hospital

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

location_facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

location_facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Centro Cardiologico Monzino, IRCCS U.O. Scompenso

location_facility: University of Iowa Hospitals and Clinics

location_facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Unidad de Investigacion Clinica en Medicina, S.C.

location_facility: Clinical Center of Serbia, Koste Todorovica 8

location_facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

location_facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

location_facility: University General Hospital of Alexandroupolis

location_facility: Fuwai Central China Cardiovascular Hospital

location_facility: VA Greater Los Angeles Healthcare System

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc

location_facility: Copenhagen University Hospital (Rigshospitalet)

status_simplified: Unknown


title: A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

acronym: BOREAS

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.

status: Recruiting

ReferenceType: background

ReferenceCitation: Al-Ali, H.K.; Delgado, R.G.; Lange, A.; Pluta, A.; McLornan, D.; Vachhani, P.; Damaj, G.L.; Jost, P.J.; Rejto, L.; Hus, M.; et al. KRT-232, A First-In-Class, Murine Double Minute 2 Inhibitor, for Myelofibrosis Relapsed or Refractory to Janus-Associated Kinase Inhibitor Treatment. Eha. Libr. 2020, 295035, S215

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
Czechia
Canada
France
Lithuania
Portugal
Hungary
Hong Kong
United States
Romania
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: University Campus of Patras - Hematology

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Gaziantep University Faculty of Medicine

location_facility: Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele

location_facility: Perpetual Succour Hospital - Hemat/Transfusion Med

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Military Medical Academy, Multiprofile for active treatment, Sofia

location_facility: Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre

location_facility: Klinikum Rechts der Isar der Technischen Universität München Apotheke

location_facility: Specialized Hospital for Active Therapy of Hematological Disorders

location_facility: Oaxaca Site Management Organization OSMO

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k.

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Spitalul Clinic Municipal Filantropia Craiova

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

location_facility: Assaf Harofeh Medical Center - Hematology

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv

location_facility: Keimyung University Dongsan Medical Center

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

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

location_facility: H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique

location_facility: Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona

location_facility: A.O. San Gerardo di Monza - L'Ospedale San Gerardo di Monza e l'Università di Milano

location_facility: Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

location_facility: Sociedad de Metabolismo y Corazón S.C. - Oncology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universidad Autonoma de Nuevo Leon (UANL) - Hospital Universitario "Dr. Jose Eleuterio Gonzalez

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su

location_facility: University of the Philippines - Philippine General Hospital

location_facility: A.O. Citta della Salute e della Scienza di Torino

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Arcispedale S. Maria Nuova, AO di Reggio Emilia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Ondokuz Mayis University Medical Faculty - Hematology

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Washington University School of Medicine

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Hospital Privado - Centro Medico de Cordoba - Oncology

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Instituto Português de Oncologia de Coimbra

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

location_facility: Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa

location_facility: Acibadem City Clinic Tokuda Hospital, Sofia

location_facility: Brookdale University Hospital and Medical Center

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Inonu University Turgut Ozal Medical Center

location_facility: Srinagarind Hospital (KhonKaen University)

location_facility: New York Presbyterian/Weill Cornell Medical Center

location_facility: UNICAMP - Universidade Estadual de Campinas Hemocentro

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Spitalul Clinic Judetean de Urgenta Tg Mures

location_facility: Ramathibodi Hospital - Mahidol University - Hematology

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia

location_facility: UKE - Universitätsklinikum Hamburg-Eppendorf

location_facility: Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Chiayi Branch

location_facility: Hospital A C Camargo - Fundacao Antonio Prudente

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden

summary: The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Celgene

location_country: Germany Italy Netherlands Austria Spain Greece France

location_facility: Private hospital "Iatriko Psychikou", Athens

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: General University Hospital of Alexandroupolis

location_facility: Ospedale di Busto Arsizio - ASST Valle Olona

location_facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

location_facility: Policlinico Umberto I , Universita La Sapienza

location_facility: Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

location_facility: HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg

location_facility: CHU de Caen, institut d'hematologie de basse Nomandie

location_facility: Ospedale Policlinico San Martino - IRCCS

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: Hospital Clínico Universiatrio de Salamanca

location_facility: General Anti-Cancer Hospital "Agios Savvas"

location_facility: Salzburger Landeskliniken - Universitaetsklinikum Salzburg

location_facility: LKH Graz Medizinische Universitätsklinik

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Theageneio General Hospital, Thessaloniki

location_facility: Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza

location_facility: General University Hospital of Athens "LAIKO", Athens

location_facility: Azienda Ospedaliero - Universiaria di Parma

location_facility: Praxis fuer Haematolgie, Onkologie und Palliativmedizin

location_facility: Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin

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

location_facility: Azienda Ospedaliero Universitaria Pisana


intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

ReferenceCitation: Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
Bristol-Myers Squibb
Nektar Therapeutics

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

status: Completed

title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

study_completion_date_type: Actual

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Portugal
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel

status_simplified: Completed


title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

summary: The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

status: Terminated

ipd_sharing: No

lead_sponsor: Chengdu Kanghong Biotech Co., Ltd.

location_country:
Italy
Slovakia
Hungary
Israel
Denmark
United Kingdom
United States
China
Latvia
Czechia
Bulgaria
France


acronym: SOLOIST-WHF

lead_sponsor: Lexicon Pharmaceuticals

summary:
Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

The total occurrences of HHF and urgent visit for HF
The occurrence of CV death
The occurrence of all-cause mortality
The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score
Change in estimated glomerular filtration rate (eGFR)

ReferenceCitation: Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Helsinki - Helda

version: publishedVersion

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: HELDA - Digital Repository of the University of Helsinki;pure.rug.nl

unpaywall_oa_status: green

publisher_dissemination: American College of Physicians

ReferenceCitation: Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Lexicon Pharmaceuticals
Sanofi

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title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure

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, blank 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 trial participants.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

location_country:
Belarus
Italy
Poland
United Kingdom
Brazil
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Russian Federation
France

location_facility: Adnan Menderes University Training and Research Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Weill Cornell Medical College - NY Presbyterian Hospital

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: White Plains Hospital Center for Cancer Care

location_facility: H. Clinico Universitario de Santiago de Compostela

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Russian Scientific Center of Roentgenoradiology

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

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Clinical Diagnostic Centre of Nizhny Novgorod Region

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Pusan National University Yangsan Hospital

location_facility: AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Private Medical Institution Euromedservice

location_facility: Institut de Cancerologie de Ouest (ICO) Site Paul Papin

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellin

location_facility: Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Nottingham University Hospitals NHS Trust


summary: The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

ReferenceType: result

ReferenceCitation: Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Van Cutsem E, Kato K, Ajani J, Shen L, Xia T, Ding N, Zhan L, Barnes G, Kim SB. Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life. ESMO Open. 2022 Aug;7(4):100517. doi: 10.1016/j.esmoop.2022.100517. Epub 2022 Jul 1.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

location_facility: AO Citta della Salute e della Scienza di Torino - Presidio O

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

location_facility: AOU - Seconda Università degli Studi di Napoli

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Universitatsklinikum Koln, Innere Medizin I

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Kobe City Medical Center General Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Hamatologisch-Onkologische Praxis Eppendorf (HOPE)

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: The First Hospital, Sun Yat-sen University

location_facility: Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital

location_facility: The Royal Marsden NHS Foundation Trust - Haemato-Oncology

location_facility: Fourth Hospital of Hebei Medical University

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)

location_facility: Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Harbin Medical University Cancer Hospital

location_facility: The First People's Hospital Of Changzhou

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Comprehensive Cancer Center-Gustave Roussy

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Anhui Medical University - The Second Hospital

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Universitaetsmedizin Mannheim, II. Medizinische Klinik

title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

location_country:
Germany
Italy
United Kingdom
Japan
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
France


lead_sponsor: Merck Sharp & Dohme LLC

summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

ReferenceCitation: Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.

ReferenceCitation: Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

oa_host_type: publisher

publisher_dissemination: Oxford University Press

location_facility: Peking Union Medical College Hospital ( Site 0809)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0383)

location_facility: Euroclinic Hospital Bucharest ( Site 0510)

location_facility: Azienda Ospedaliera San Gerardo ( Site 0308)

location_facility: National Cancer Center Hospital ( Site 0767)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

location_facility: Pauls Stradins Clinical University Hospital ( Site 0911)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0769)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0603)

location_facility: Providence Saint Joseph Medical Center ( Site 0061)

location_facility: IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0723)

location_facility: Providence Regional Cancer Partnership ( Site 0065)

location_facility: Hospital Privado de Comunidad. ( Site 0130)

location_facility: Northwest Oncology and Hematology ( Site 0001)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0267)

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)

location_facility: Fukushima Medical University Hospital ( Site 0772)

location_facility: UPMC Pinnacle Health System - East Location ( Site 0063)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

location_facility: Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0382)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)

location_facility: MI Odessa Regional Oncological Centre ( Site 0608)

location_facility: Tri-Service General Hospital ( Site 0726)

location_facility: Plymouth Hospitals NHS Trust ( Site 0443)

location_facility: Municipal Clinical Oncology Center ( Site 0523)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0280)

location_facility: Hospital de Caridade de Ijui ( Site 0153)

location_facility: National Taiwan University Hospital ( Site 0721)

location_facility: Peking University Third Hospital ( Site 0812)

location_facility: Evangelische Lungenklinik Berlin ( Site 0274)

location_facility: Banner MD Anderson Cancer Center ( Site 0028)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0273)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0060)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0019)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0314)

location_facility: National Cancer Center Hospital East ( Site 0761)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 0509)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)

location_facility: Hôpital Avicenne - Service d oncologie medicale ( Site 0249)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0311)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)

location_facility: Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0725)

location_facility: OHSU Center for Health & Healing ( Site 1006)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 0277)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 0039)

location_facility: White Plains Hospital Center for Cancer Care ( Site 0007)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0313)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0150)

location_facility: University of Nebraska Medical Center ( Site 0047)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)

location_facility: Virginia Cancer Specialists, PC ( Site 0080)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0145)

location_facility: Riga East Clinical University Hospital ( Site 0912)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: Ashland-Bellefonte Cancer Center ( Site 0021)

location_facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0458)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0158)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

location_facility: Kyiv City Clinical Oncological Center ( Site 0601)

location_facility: Tianjin Medical University General Hospital ( Site 0806)

location_facility: Heartlands Hospital in Birmingham ( Site 0455)

location_facility: SMG-SNU Boramae Medical Center ( Site 0707)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0572)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0705)

location_facility: Zhejiang Cancer Hospital.... ( Site 0814)

location_facility: University Malaya Medical Centre ( Site 0781)

location_facility: Nacionalinis Vezio Institutas ( Site 0931)

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)

location_facility: Southeastern Regional Medical Center ( Site 0051)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0804)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 0491)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 0385)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0264)

location_facility: Cherkassy Regional Oncological Center ( Site 0613)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 1100)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)

location_facility: John Wayne Cancer Institute ( Site 0049)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)

location_facility: Spitalul clinic Judetean de urgenta Constanta ( Site 0508)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0526)

location_facility: Helen F. Graham Cancer Center & Research Institute ( Site 0015)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 0505)

location_facility: Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)

location_facility: UMass Memorial Medical Center ( Site 0030)

location_facility: China Medical University Hospital ( Site 0724)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0524)

location_facility: Saint Francis Cancer Center ( Site 0096)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)

location_facility: Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)

location_facility: Nottingham City Hospital Campus ( Site 0441)

location_facility: Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)

location_facility: Inova Schar Cancer Institute ( Site 0032)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0242)

location_facility: Centrul Medical Medicover Victoria ( Site 0514)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

location_facility: Instituto do Cancer do Ceara ( Site 0152)

location_facility: VA Pittsburgh Healthcare System ( Site 0052)

location_facility: Stanford University, Stanford Cancer Center ( Site 0046)

location_facility: University of Arizona Cancer Center - Dignity Health ( Site 0062)

location_facility: St Joseph Heritage Healthcare ( Site 0040)

location_facility: Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

location_facility: McGill University Health Centre ( Site 0111)

location_facility: City Clinical Hosp.4 of DCC ( Site 0607)

location_facility: Zhongshan Hospital of Fudan University ( Site 0808)

location_facility: Miami Cancer Institute-Baptist Hospital ( Site 0068)

location_facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0822)

location_facility: Southwestern Regional Medical Center, Inc. ( Site 0054)

location_facility: Aichi Cancer Center Hospital ( Site 0765)

location_facility: Tokyo Medical University Hospital ( Site 0771)

location_facility: HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0258)

location_facility: Hospital Universitari Vall d Hebron ( Site 0389)

location_facility: University of Arizona Cancer Center ( Site 0012)

location_facility: Western Regional Medical Center, Inc. ( Site 0050)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)

location_facility: Pacific Cancer Medical Center, Inc. ( Site 0004)

location_facility: Juntendo University Hospital ( Site 0768)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)

location_facility: S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)

location_facility: University of Iowa Hospital and Clinics ( Site 0010)

location_facility: Princess Margaret Cancer Centre ( Site 0109)

location_facility: Florence Nightingale Krankenhaus ( Site 0874)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0816)

location_facility: Medical Rehabilitation Center ( Site 0534)

location_facility: Universitaetsklinikum Schleswig Holstein ( Site 0871)

location_facility: Taipei Veterans General Hospital ( Site 0722)

location_facility: Hiroshima University Hospital ( Site 0762)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)

location_facility: Fudan University Shanghai Cancer Center ( Site 0813)

location_facility: LKI Lungenfachklinik Immenhausen ( Site 0268)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)

location_facility: Emily Couric Clinical Cancer Center ( Site 0013)

location_facility: UPMC Hillman Cancer Centers ( Site 0041)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0605)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)

location_facility: Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

location_facility: National Medical Research Radiology Centre ( Site 0535)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0139)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0388)

location_facility: Hospital Provincial del Centenario ( Site 0131)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 0303)

location_facility: Hospital Universitario Austral ( Site 0127)

title: A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Lithuania
United States
Latvia
Ukraine
Romania
Belgium
China
Malaysia
Estonia
Italy
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


lead_sponsor: Bayer

summary:
This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.

The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.

At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

ReferenceCitation: Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, Garcia Del Muro X, Joly F, Papai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2023 Jan 20;41(3):629-639. doi: 10.1200/JCO.21.02303. Epub 2022 Oct 14.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Wiley

location_facility: Severance Hospital, Yonsei University Health System

location_facility: IRST Istituto Scientifico Romagnolo per studio e cura tumori

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: Huadong Hospital, Affiliated to Fudan University

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Kobe City Medical Center General Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary

location_facility: Fifth Medical Center, General Hospital of the Chinese People

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: Hospital General Universitario de Valencia

location_facility: Saitama Medical University International Medical Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: FuJian Medical University Union Hospital

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Princess Margaret Hospital-University Health Network

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

location_facility: Herlev Hospital - Oncology Research Dept.

location_facility: Niigata University Medical and Dental Hospital

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Hadassah Hebrew University Hospital Ein Kerem

title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

location_country:
Finland
Germany
Ireland
Poland
Australia
Japan
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma

summary: The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

lead_sponsor: Ichnos Sciences SA

sponsor_collaborators:
Ichnos Sciences SA
Glenmark Pharmaceuticals S.A.

location_country:
United States
France

location_facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

location_facility: Mayo Clinic Cancer Center (MCCC) - Rochester

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: University of Arkansas for Medical Sciences (UAMS)

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

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University of Wisconsin Hospital and Clinics