107
Participants
Start Date
February 28, 2020
Primary Completion Date
July 12, 2024
Study Completion Date
February 27, 2025
Erdafitinib
Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.
Investigator Choice (Gemcitabine)
Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
Investigator Choice (Mitomycin C)
Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
St Vincent s Hospital Sydney, Darlinghurst
Macquarie University, Macquarie University
Peter MacCallum Cancer Centre, Melbourne
UZ Leuven, Leuven
CHU Sart-Tilman, Liège
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba
Flinders Medical Centre, Bedford Park
Hosp Clinic de Barcelona, Barcelona
Algemeen Ziekenhuis Delta, Roeselare
AZ Maria Middelares, Ghent
National Taiwan University Hospital, Taipei
NYU Langone Health, New York
National Cancer Center, Goyang-si
Montefiore Medical Center, The Bronx
Ospedale Regionale Umberto Parini, Aosta
Taipei Veterans General Hospital, Taipei
Albany Medical College, Albany
Institut Paoli Calmettes, Marseille
Great Lakes Physician PC d/b/a Western New York Urology Associates, Sanborn
University of Pittsburgh Medical Center - Cancer Centers, Pittsburgh
MidLantic Urology, Bala-Cynwyd
IRCCS Ospedale San Raffaele, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck
Hosp. Univ. Ramon Y Cajal, Madrid
Hosp. Univ. 12 de Octubre, Madrid
Hosp. Univ. La Paz, Madrid
Levine Cancer Institute, Charlotte
Emory University Winship Cancer Institute, Atlanta
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse
Urological Research Network, Hialeah
Hopital Pellegrin CHU Bordeaux, Bordeaux
Chang Gung Memorial Hospital- Linkou, Taoyuan
Chu Rennes Hopital Pontchaillou, Rennes
CHP Saint Gregoire, Saint-Grégoire
Azienda Ospedaliera Universitaria Integrata Verona, Verona
Urology Associates, Nashville
Hosp. Univ. Marques de Valdecilla, Santander
China Medical University Hospital, Taichung
Taichung Veterans General Hospital, Taichung
Kyungpook National University Chilgok Hospital, Daegu
Ospedale Civile di Guastalla, Guastalla
The Ohio State University- James Cancer Hospital, Columbus
Klinikum Herne - Urologie, Herne
The Urology Group, Cincinnati
Praxisklinik Urologie Rhein/Ruhr - Germany, Mülheim
Instituto Valenciano de Oncologia, Valencia
Urologicum Duisburg, Duisburg
Universitaetsklinikum Muenster, Münster
Pusan National University Hospital, Busan
CUROS - Uberörtliche urologische Gemeinschaftspraxis, Wesseling
Medical College of Wisconsin Froedtert Hospital, Milwaukee
Centre Hospitalier Universitaire de Nancy - Hôpital Central, Vandœuvre-lès-Nancy
Chonnam National University Hwasun Hospital, Jeollanam-do
Hopital Huriez, Lille
Northwestern University, Chicago
UOC Oncologia Ospedale Provinciale di Macerata, Macerata
Simmons Cancer Institute, Springfield
CHU Gabriel-Montpied, Clermont-Ferrand
University of Kansas, Westwood
Hôpital Edouard Herriot, Lyon
Ente Ecclesiastico Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti
Studienpraxis Urologie Drs. Feyerabend, Nürtingen
Azienda Ospedaliera ''Vito Fazzi'', Lecce
Hôpital Universitaire Pitié-Salpêtrière, Paris
Groupe Hospitalier Diaconesses Croix Saint Simon, Paris
UT Southwestern Medical Center, Dallas
Hopital Bichat Claude Bernard, Paris
Hopital Charles Nicolle, Rouen
Fondazione G Pascale Istituto Nazionale Tumori IRCCS, Napoli
The Urology Center of Colorado, Denver
Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik, München
Urological Associates of Southern Arizona, P.C., Tucson
CHU De Poitiers, Poitiers
Fondazione Istituto G. Giglio, Cefalù
USC Institute of Urology, Los Angeles
MVZ Urologie 24 gGmbH, Nuremberg
Gustave Roussy, Villejuif
Oregon Health And Science University, Portland
University of Washington, Seattle
Rajiv Gandhi Cancer Institute & Research Centre, Delhi
Fudan University Shanghai Cancer Center, Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Nanjing Drum Tower Hospital, Nanjing
King Georges Medical University, Lucknow
Muljibhai Patel Urological Hospital, Nadiād
CIMET s Inamdar Multispeciality Hospital, Pune
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan
Health Care Global Enterprises pvt Ltd, Bangalore
Meenakshi Mission Hospital and Research Center, Madurai
Sociedade Beneficente de Senhoras Hospital Sirio Libanes, Buenos Aires
CEMIC Saavedra, Buenos Aires
Hospital Britanico de Buenos Aires, Buenos Aires
Hospital Italiano de Buenos Aires, Ciudad Autonoma de
Centro Urologico Profesor Bengio, Córdoba
Hospital Privado de Cordoba, Córdoba
Liga Paranaense de Combate ao Cancer, Curitiba
Oncocentro Ceará, Fortaleza
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge, Goiânia
Liga Norte Riograndense Contra O Cancer, Natal
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Hospital Nossa Senhora da Conceicao S A, Porto Alegre
Instituto de Medicina Integral Professor Fernando Figueira, Recife
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP, Ribeirão Preto
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo, São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, São Paulo
Fakultni nemocnice u sv. Anny v Brne, Brno
Krajská nemocnice Liberec, Liberec
Vseobecna fakultni nemocnice v Praze, Prague
Fakultni nemocnice v Motole, Prague
Azienda Ospedaliera Sant Andrea, Roma
Juntendo University Hospital, Bunkyō City
Tokyo Medical and Dental University Hospital, Bunkyō City
Asahi General Hospital, Chiba
Hakodate Goryoukaku Hospital, Hakodate
Saitama Medical University International Medical Center, Hidaka
Hitachi General Hospital, Hitachi
St Marianna University Hospital, Kanagawa
Nagoya University Hospital, Nagoya
JOHAS Osaka Rosai Hospital, Osaka
Gunma Prefectural Cancer Center, Ōta-ku
Osaka Medical and Pharmaceutical University Hospital, Takatsuki
Toranomon Hospital, Tokyo
The Cancer Institute Hospital of JFCR, Tokyo
Fujita Health University Hospital, Toyoake
University of Tsukuba Hospital, Tsukuba
Yokohama City University Medical Center, Yokohama
Uniwersyteckie Centrum Kliniczne, Gdansk
Pratia MCM Krakow, Krakow
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie, Rzeszów
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM, Szczecin
Medical Concierge Centrum Medyczne, Warsaw
City Clinic Sp. z o.o., Warsaw
Uniwersytecki Szpital Kliniczny, Wroclaw
Chungbuk National University Hospital, Cheongju-si
Korea University Anam Hospital, Seoul
Seoul National University Hospital, Seoul
Kangbuk Samsung Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Samsung Medical Center, Seoul
Fund. Puigvert, Barcelona
Corporacio Sanitari Parc Tauli, Sabadell
The Christie NHS Foundation Trust Christie Hospital, Manchester
Universirty of Sheffield Teaching Hospitals NHS Trust, Sheffield
Lister Hospital, Stevenage
Janssen Research & Development, LLC
INDUSTRY