To learn more about biomarkers such as the FGFR mutations in this trial, please click here, or copy and paste this link into your browser: https://content.gtc-api.dev/sites/default/files/2020-08/GTC_OnlineEngagement-ENG09_Biomarkers_V1.0_040220_Final.mp4
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.
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
MMC/hyperthermic MMC). The study consists of Screening period, Treatment Phase and Follow-up
Phase.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | February 28, 2020 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Recurrence-Free Survival (RFS)
Primary Outcome 1 - Time Frame: Up to 4 years
Criteria:
Inclusion Criteria:
- Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the
bladder. Variant pathology are allowed
- Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
- Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG
experienced participants
- Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
- Must sign an informed consent form (ICF) (or their legally acceptable representative
must sign) indicating that he or she understands the purpose of, and procedures
required for, the study and is willing to participate in the study
- A woman of childbearing potential must have a negative pregnancy test (beta-hCG
[beta-human chorionic gonadotropin]) (urine or serum) within 7 days before
randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
- Adequate bone marrow, liver, and renal function as specified in the protocol
Exclusion Criteria:
- Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of
the bladder
- Histopathology demonstrating any small cell component, pure adenocarcinoma, pure
squamous cell carcinoma, or pure squamous CIS of the bladder
- Prior treatment with an FGFR inhibitor
- Active malignancies other than the disease being treated under study. The only allowed
exceptions are: (a) skin cancer treated within the last 24 months that is considered
completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal
CIS (c) history of localized breast cancer and receiving antihormonal agents, or
history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
- Current central serous retinopathy or retinal pigment epithelial detachment of any
grade
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Janssen Research & Development, LLC Clinical Trial
Role: Study Director
Affiliation: Janssen Research & Development, LLC
Name: Study Contact
Phone: 844-434-4210
Email: JNJ.CT@sylogent.com
Link: To learn how to participate in this trial please click here.
Facility | Status | Contact |
---|---|---|
Urological Associates of Southern Arizona, P.C. Tucson, Arizona 85741 United States |
Recruiting | |
USC Institute of Urology Los Angeles, California 48109 United States |
Recruiting | |
The Urology Center of Colorado Denver, Colorado 80211 United States |
Recruiting | |
Foothills Urology - Golden Off Golden, Colorado 80401-5027 United States |
Withdrawn | |
Urological Research Network Hialeah, Florida 33016 United States |
Recruiting | |
Tampa General Hospital Tampa, Florida 33578 United States |
Withdrawn | |
Emory University - Winship Cancer Institute Atlanta, Georgia 30322 United States |
Recruiting | |
Northwestern University Chicago, Illinois 60611 United States |
Not yet recruiting | |
Simmons Cancer Institute Springfield, Illinois 62702 United States |
Not yet recruiting | |
University of Kansas Westwood, Kansas 66205 United States |
Not yet recruiting | |
University of Kentucky Lexington, Kentucky 40536 United States |
Withdrawn | |
LSU Healthcare Network Metairie, Louisiana 70006 United States |
Withdrawn | |
Regional Urology Shreveport, Louisiana 71106 United States |
Withdrawn | |
MI Medicine Ann Arbor, Michigan 48109 United States |
Withdrawn | |
University of Missouri Columbia, Missouri 65212 United States |
Withdrawn | |
Albany Medical College Albany, New York 12208 United States |
Recruiting | |
Montefiore Medical Center Bronx, New York 10461 United States |
Recruiting | |
NYU Langone Health New York, New York 10017 United States |
Not yet recruiting | |
Strong Memorial Hospital University of Rochester Rochester, New York 16442 United States |
Withdrawn | |
Great Lakes Physician PC d/b/a Western New York Urology Associates Sanborn, New York 14132 United States |
Recruiting | |
Levine Cancer Institute Charlotte, North Carolina 28204 United States |
Recruiting | |
Ohio State University Columbus, Ohio 43210 United States |
Not yet recruiting | |
Oregon Health & Science University Portland, Oregon 97239 United States |
Not yet recruiting | |
Urologic Consultants of Southeastern PA Bala-Cynwyd, Pennsylvania 19004 United States |
Recruiting | |
Lancaster Urology Lancaster, Pennsylvania 17604 United States |
Withdrawn | |
University of Pittsburgh Medical Center - Cancer Centers Pittsburgh, Pennsylvania 15232 United States |
Not yet recruiting | |
Urology Associates Nashville, Tennessee 37209 United States |
Recruiting | |
UT Southwestern Medical Center Dallas, Texas 75390-8565 United States |
Recruiting | |
University of Washington Seattle, Washington 98008 United States |
Recruiting | |
William S. Middleton Memorial VA Madison, Wisconsin 53705 United States |
Not yet recruiting | |
Medical College of Wisconsin-Froedtert Hospital Milwaukee, Wisconsin 53226 United States |
Not yet recruiting | |
Hospital Sirio Libanes Buenos Aires, C1419AHN Argentina |
Not yet recruiting | |
Hospital Britanico de Buenos Aires Buenos Aires, Argentina |
Not yet recruiting | |
CEMIC Saavedra Ciudad Autonoma de Buenos Aires, C1431FWN Argentina |
Not yet recruiting | |
Hospital Italiano de Buenos Aires Ciudad Autonoma de, C1199ABB Argentina |
Not yet recruiting | |
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Cordoba, 5000 Argentina |
Not yet recruiting | |
Centro Urologico Profesor Bengio Cordoba, X5000KPH Argentina |
Not yet recruiting | |
Hospital Privado de Cordoba Cordoba, XX5016KEH Argentina |
Not yet recruiting | |
Flinders Medical Centre Bedford Park, 5042 Australia |
Not yet recruiting | |
St. Vincent's Hospital Sydney Darlinghurst, 2010 Australia |
Not yet recruiting | |
Macquarie University Macquarie University, 2109 Australia |
Not yet recruiting | |
Peter MacCallum Cancer Centre Melbourne, 3000 Australia |
Recruiting | |
Newcastle Private Hospital New Lambton Heights, 2305 Australia |
Withdrawn | |
ICON Cancer Care South Brisbane, 4101 Australia |
Withdrawn | |
Sydney Adventist Hospital Wahroonga, 2076 Australia |
Withdrawn | |
Princess Alexandra Hospital Woolloongabba, 4102 Australia |
Withdrawn | |
Cliniques Universitaires Saint Luc Brussel, 1200 Belgium |
Withdrawn | |
AZ Maria Middelares Gent, 9000 Belgium |
Recruiting | |
UZ Leuven Leuven, 3000 Belgium |
Recruiting | |
CHU Sart-Tilman Liege, 4000 Belgium |
Recruiting | |
Algemeen Ziekenhuis Delta Roeselare, 8800 Belgium |
Recruiting | |
Hospital Erasto Gaertner Curitiba, 81520-060 Brazil |
Recruiting | |
Oncocentro Ceará Fortaleza, 60135-237 Brazil |
Recruiting | |
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Goiânia, 74605-070 Brazil |
Recruiting | |
Liga Norte Riograndense Contra O Cancer Natal, 59075-740 Brazil |
Recruiting | |
Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, 90050170 Brazil |
Recruiting | |
Hospital Nossa Senhora da Conceicao Porto Alegre, 91410-330 Brazil |
Not yet recruiting | |
Instituto de Medicina Integral Professor Fernando Figueira Recife, 50070-550 Brazil |
Recruiting | |
Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto Ribeirão Preto, 14048 900 Brazil |
Recruiting | |
Centro de Tratamento de Tumores Botafogo - CTTB Rio de Janeiro, 22250-905 Brazil |
Recruiting | |
Instituto COI de Pesquisa, Educacao e Gestao Rio de Janeiro, 22793-080 Brazil |
Recruiting | |
Faculdade de Medicina Do Abc Santo André, 09060-650 Brazil |
Not yet recruiting | |
Instituto do Cancer do Estado de Sao Paulo ICESP Sao Paulo, 01246-000 Brazil |
Not yet recruiting | |
Hospital Do Servidor Publico Estadual Sao Paulo, 04039-004 Brazil |
Recruiting | |
Hospital Sirio Libanes São Paulo, 01308-050 Brazil |
Not yet recruiting | |
Nanjing Drum Tower Hospital Nanjing, 210008 China |
Not yet recruiting | |
Fudan University Shanghai Cancer Center Shanghai, 200032 China |
Not yet recruiting | |
Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai, 200240 China |
Not yet recruiting | |
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan, 430030 China |
Not yet recruiting | |
Fakultni nemocnice u sv. Anny v Brne Brno, 656 91 Czechia |
Not yet recruiting | |
Krajská nemocnice Liberec Liberec, 460 63 Czechia |
Recruiting | |
Urologicka klinika FNOL Olomouc, 775 20 Czechia |
Not yet recruiting | |
Vseobecna fakultni nemocnice v Praze Praha 2, 128 08 Czechia |
Not yet recruiting | |
Fakultni nemocnice v Motole Praha 5, 150 06 Czechia |
Not yet recruiting | |
Hôpital Pellegrin CHU Bordeaux Bordeaux, 33076 France |
Not yet recruiting | |
CHU Gabriel-Montpied Clermont Ferrand, 63000 France |
Recruiting | |
Hopital Huriez Lille, 59037 France |
Recruiting | |
Hôpital Edouard Herriot Lyon Cedex 03, 69437 France |
Recruiting | |
Institut Paoli Calmettes Marseille Cedex 9, 13273 France |
Recruiting | |
Hôpital Universitaire Pitié-Salpêtrière Paris, 75013 France |
Recruiting | |
Groupe Hospitalier Diaconesses Croix Saint Simon Paris, 75020 France |
Not yet recruiting | |
Hopital Bichat Claude Bernard Paris, 75877 France |
Recruiting | |
CHU De Poitiers Poitiers, 86021 France |
Recruiting | |
Chu Rennes - Hopital Pontchaillou Rennes Cedex, 35033 France |
Recruiting | |
Hopital Charles Nicolle Rouen, 76031 France |
Recruiting | |
CHP Saint Gregoire Saint Gregoire, 35760 France |
Recruiting | |
Institut Universitaire du Cancer Toulouse Oncopole Toulouse, 31000 France |
Not yet recruiting | |
Centre Hospitalier Universitaire de Nancy - Hôpital Central Vandoeuvre-Les-Nancy, 54500 France |
Not yet recruiting | |
Gustave Roussy Villejuif Cedex, 94800 France |
Not yet recruiting | |
GFO Kliniken Rhein Berg Bergisch-Gladbach, 51465 Germany |
Not yet recruiting | |
Urologicum Duisburg Duisburg, 47179 Germany |
Recruiting | |
Praxis Dr. med. Stefan Carl Emmendingen, 79312 Germany |
Withdrawn | |
Klinikum Herne - Urologie Herne, 44625 Germany |
Recruiting | |
Universitätsklinikum Schleswig Holstein Campus Lübeck Lubeck, 23538 Germany |
Recruiting | |
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik Muenchen, 81675 Germany |
Not yet recruiting | |
Universitaetsklinikum Muenster Muenster, 48149 Germany |
Recruiting | |
Praxisklinik Urologie Rhein/Ruhr - Germany Mülheim an der Ruhr, 45468 Germany |
Recruiting | |
MVZ Urologie 24 gGmbH Nuernberg, 90491 Germany |
Not yet recruiting | |
Studienpraxis Urologie Drs. Feyerabend Nuertingen, 72622 Germany |
Recruiting | |
CUROS - Uberörtliche urologische Gemeinschaftspraxis Wesseling, 50389 Germany |
Recruiting | |
Rajiv Gandhi Cancer Institute & Research Centre Delhi, 110085 India |
Not yet recruiting | |
Meenakshi Mission Hospital and Research Center Madhurai, 625107 India |
Not yet recruiting | |
Tata Memorial Hospital Mumbai, 400012 India |
Not yet recruiting | |
Muljibhai Patel Urological Hospital Nadiad, 387001 India |
Not yet recruiting | |
Generale Regionale F. Miulli Acquaviva delle Fonti, 70021 Italy |
Recruiting | |
Ospedale Regionale Umberto Parini Aosta, 11100 Italy |
Not yet recruiting | |
Fondazione Istituto G. Giglio Cefalu, 90015 Italy |
Not yet recruiting | |
Ospedale Civile di Guastalla Guastalla, 42016 Italy |
Not yet recruiting | |
Azienda Ospedaliera ''Vito Fazzi'' Lecce, 73100 Italy |
Not yet recruiting | |
UOC Oncologia Ospedale Provinciale di Macerata Macerata, 62100 Italy |
Not yet recruiting | |
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, 20133 Italy |
Not yet recruiting | |
Humanitas Centro Catanese di Oncologia Misterbianco/Catania, 95045 Italy |
Not yet recruiting | |
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS Napoli, 80138 Italy |
Not yet recruiting | |
Azienda Ospedaliera Sant Andrea Roma, 00189 Italy |
Recruiting | |
Azienda Ospedaliera Universitaria Integrata Verona Verona, 37126 Italy |
Recruiting | |
Tokyo Medical and Dental University Medical Hospital Bunkyo-Ku, 113-8519 Japan |
Recruiting | |
Asahi General Hospital Chiba, 289-2511 Japan |
Recruiting | |
Hitachi General Hospital Hitachi, 317-0077 Japan |
Recruiting | |
The Cancer Institute Hospital of JFCR Koto-Ku, 135-8550 Japan |
Recruiting | |
JOHAS Osaka Rosai Hospital Osaka, 591-8025 Japan |
Recruiting | |
Osaka Medical College Hospital Takatsuki, 569-8686 Japan |
Recruiting | |
Toranomon Hospital Tokyo, 105-8470 Japan |
Recruiting | |
University of Tsukuba Hospital Tsukuba-City, 305-8576 Japan |
Recruiting | |
Pusan National University Hospital. Busan, 49241 Korea, Republic of |
Recruiting | |
Chungbuk National University Hospital Cheongju, 361-711 Korea, Republic of |
Recruiting | |
Kyungpook National University Chilgok Hospital Daegu, 41404 Korea, Republic of |
Recruiting | |
National Cancer Center Goyang-si, 10408 Korea, Republic of |
Recruiting | |
Chonnam National University Hwasun Hospital Jeollanam-do, 58128 Korea, Republic of |
Recruiting | |
Korea University Medical Center (KUMC) - Korea University Anam Hospital Seoul, 02841 Korea, Republic of |
Recruiting | |
Seoul National University Hospital Seoul, 03080 Korea, Republic of |
Recruiting | |
Kangbuk Samsung Hospital Seoul, 03181 Korea, Republic of |
Recruiting | |
Severance Hospital, Yonsei University Health System Seoul, 03722 Korea, Republic of |
Recruiting | |
Samsung Medical Center Seoul, 06351 Korea, Republic of |
Recruiting | |
Uniwersyteckie Centrum Kliniczne Gdańsk, 80-214 Poland |
Recruiting | |
Pratia MCM Krakow Krakow, 30-510 Poland |
Recruiting | |
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz, 93-411 Poland |
Withdrawn | |
CRC Sp. z o.o. Poznan, 60-848 Poland |
Not yet recruiting | |
City Clinic Sp. z o.o. Warszawa, 02-473 Poland |
Recruiting | |
Medical Concierge Centrum Medyczne Warszawa, 02-798 Poland |
Recruiting | |
Uniwersytecki Szpital Kliniczny Wroclaw, 50-556 Poland |
Recruiting | |
Dolnoslaskie Centrum Onkologii Wroclaw, 53-413 Poland |
Withdrawn | |
Fundacion Puigvert Barcelona, 08025 Spain |
Recruiting | |
Hosp. Clinic I Provincial de Barcelona Barcelona, 8036 Spain |
Recruiting | |
Hosp. Univ. Ramon Y Cajal Madrid, 28034 Spain |
Not yet recruiting | |
Hosp. Univ. 12 de Octubre Madrid, 28041 Spain |
Recruiting | |
Hosp. Univ. La Paz Madrid, 28046 Spain |
Recruiting | |
Corporacio Sanitari Parc Tauli Sabadell, 08208 Spain |
Recruiting | |
Hosp. Univ. Marques de Valdecilla Santander, 39008 Spain |
Recruiting | |
Instituto Valenciano de Oncologia Valencia, 46009 Spain |
Recruiting | |
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, 80756 Taiwan |
Recruiting | |
China Medical University Hospital Taichung, 40447 Taiwan |
Recruiting | |
Taichung Veterans General Hospital Taichung, 40705 Taiwan |
Recruiting | |
National Taiwan University Hospital Taipei, 10002 Taiwan |
Recruiting | |
Taipei Veterans General Hospital Taipei, 11217 Taiwan |
Recruiting | |
Chang Gung Memorial Hospital- Linkou Taoyuan County, 33305 Taiwan |
Not yet recruiting | |
Royal Surrey County Hospital NHS Trust Guildford, GU2 7XX United Kingdom |
Withdrawn | |
University College London Hospitals London, NW1 2BU United Kingdom |
Withdrawn | |
The Christie NHS Foundation Trust - Christie Hospital Manchester, M20 4BX United Kingdom |
Not yet recruiting | |
South Tees Hospital NHS Foundation Trust-The James Cook University Hospital Middlesborough, TS4 3BW United Kingdom |
Not yet recruiting | |
Universirty of Sheffield Teaching Hospitals NHS Trust Sheffield, S10 2JF United Kingdom |
Not yet recruiting | |
Lister Hospital Stevenage, SG1 4AB United Kingdom |
Not yet recruiting |