Spots Global Cancer Trial Database for A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
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Trial Identification
Brief Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Official Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Study ID: NCT04172675
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
Detailed Description: This study enrolls participants with high risk NMIBC and FGFR mutations or fusions. Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical mitomycin C \[MMC\] or hyperthermic MMC). The study consists of screening period, treatment phase, follow-up phase, and long-term extension phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States
USC Institute of Urology, Los Angeles, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Urological Research Network, Hialeah, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Simmons Cancer Institute, Springfield, Illinois, United States
University of Kansas, Westwood, Kansas, United States
Albany Medical College, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
NYU Langone Health, New York, New York, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates, Sanborn, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
The Urology Group, Cincinnati, Ohio, United States
The Ohio State University- James Cancer Hospital, Columbus, Ohio, United States
Oregon Health And Science University, Portland, Oregon, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
University of Pittsburgh Medical Center - Cancer Centers, Pittsburgh, Pennsylvania, United States
Urology Associates, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
University of Washington, Seattle, Washington, United States
Medical College of Wisconsin Froedtert Hospital, Milwaukee, Wisconsin, United States
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires, Buenos Aires, , Argentina
CEMIC Saavedra, Ciudad Autonoma de Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de, , Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Cordoba, , Argentina
Centro Urologico Profesor Bengio, Cordoba, , Argentina
Hospital Privado de Cordoba, Cordoba, , Argentina
Flinders Medical Centre, Bedford Park, , Australia
St. Vincent's Hospital Sydney, Darlinghurst, , Australia
Macquarie University, Macquarie University, , Australia
Peter MacCallum Cancer Centre, Melbourne, , Australia
AZ Maria Middelares, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU Sart-Tilman, Liege, , Belgium
Algemeen Ziekenhuis Delta, Roeselare, , Belgium
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Oncocentro Ceará, Fortaleza, , Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge, Goiania, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Hospital Nossa Senhora da Conceicao S A, Porto Alegre, , Brazil
Instituto de Medicina Integral Professor Fernando Figueira, Recife, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP, Ribeirão Preto, , Brazil
Comite de Etica em Pesquisa em Seres Humanos do Hospital Pro-Cardiaco CEP HPC, Rio de Janeiro, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo Andre, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo, , Brazil
Nanjing Drum Tower Hospital, Nanjing, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, , China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
Fakultni nemocnice u sv. Anny v Brne, Brno, , Czechia
Krajská nemocnice Liberec, Liberec, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Hopital Pellegrin CHU Bordeaux, Bordeaux, , France
CHU Gabriel-Montpied, Clermont Ferrand, , France
Hopital Huriez, Lille, , France
Hôpital Edouard Herriot, Lyon Cedex 03, , France
Institut Paoli Calmettes, Marseille Cedex 9, , France
Hôpital Universitaire Pitié-Salpêtrière, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, , France
Hopital Bichat Claude Bernard, Paris, , France
CHU De Poitiers, Poitiers, , France
Chu Rennes Hopital Pontchaillou, Rennes Cedex, , France
Hopital Charles Nicolle, Rouen, , France
CHP Saint Gregoire, Saint Gregoire, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, , France
Centre Hospitalier Universitaire de Nancy - Hôpital Central, Vandœuvre-lès-Nancy Cedex, , France
Gustave Roussy, Villejuif Cedex, , France
Urologicum Duisburg, Duisburg, , Germany
Klinikum Herne - Urologie, Herne, , Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lubeck, , Germany
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik, Muenchen, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Praxisklinik Urologie Rhein/Ruhr - Germany, Mülheim an der Ruhr, , Germany
MVZ Urologie 24 gGmbH, Nuernberg, , Germany
Studienpraxis Urologie Drs. Feyerabend, Nuertingen, , Germany
CUROS - Uberörtliche urologische Gemeinschaftspraxis, Wesseling, , Germany
Health Care Global Enterprises pvt Ltd, Bangalore, , India
Rajiv Gandhi Cancer Institute & Research Centre, Delhi, , India
King Georges Medical University, Lucknow, , India
Meenakshi Mission Hospital and Research Center, Madhurai, , India
Muljibhai Patel Urological Hospital, Nadiad, , India
CIMET s Inamdar Multispeciality Hospital, Pune, , India
Ente Ecclesiastico Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, , Italy
Ospedale Regionale Umberto Parini, Aosta, , Italy
Fondazione Istituto G. Giglio, Cefalu, , Italy
Ospedale Civile di Guastalla, Guastalla, , Italy
Azienda Ospedaliera ''Vito Fazzi'', Lecce, , Italy
UOC Oncologia Ospedale Provinciale di Macerata, Macerata, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IRCCS Ospedale San Raffaele, Milan, , Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS, Napoli, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Juntendo University Hospital, Bunkyo Ku, , Japan
Tokyo Medical and Dental University Hospital, Bunkyo-Ku, , Japan
Asahi General Hospital, Chiba, , Japan
Hakodate Goryoukaku Hospital, Hakodate, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Hitachi General Hospital, Hitachi, , Japan
St Marianna University Hospital, Kanagawa, , Japan
Nagoya University Hospital, Nagoya, , Japan
JOHAS Osaka Rosai Hospital, Osaka, , Japan
Gunma Prefectural Cancer Center, Ota, , Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki, , Japan
Toranomon Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Fujita Health University Hospital, Toyoake, , Japan
University of Tsukuba Hospital, Tsukuba-City, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Pratia MCM Krakow, Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie, Rzeszow, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM, Szczecin, , Poland
City Clinic Sp. z o.o., Warszawa, , Poland
Medical Concierge Centrum Medyczne, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny, Wroclaw, , Poland
Fund. Puigvert, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Corporacio Sanitari Parc Tauli, Sabadell, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital- Linkou, Taoyuan County, , Taiwan
The Christie NHS Foundation Trust Christie Hospital, Manchester, , United Kingdom
Universirty of Sheffield Teaching Hospitals NHS Trust, Sheffield, , United Kingdom
Lister Hospital, Stevenage, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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