Bladder Cancer Clinical Trial

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)

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.

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Full 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 MMC/hyperthermic MMC). The study consists of Screening period, Treatment Phase and Follow-up Phase.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

105

Study ID:

NCT04172675

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 177 Locations for this study

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Urological Associates of Southern Arizona, P.C.
Tucson Arizona, 85741, United States
USC Institute of Urology
Los Angeles California, 90033, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Foothills Urology - Golden Off
Golden Colorado, 80401, United States
Urological Research Network
Hialeah Florida, 33016, United States
Tampa General Hospital
Tampa Florida, 33578, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Simmons Cancer Institute
Springfield Illinois, 62702, United States
University of Kansas
Westwood Kansas, 66205, United States
University of Kentucky
Lexington Kentucky, 40536, United States
LCMC Health
Metairie Louisiana, 70006, United States
Ochsner LSU Health Shreveport - Regional Urology
Shreveport Louisiana, 71106, United States
MI Medicine
Ann Arbor Michigan, 48109, United States
University of Missouri
Columbia Missouri, 65212, United States
Albany Medical College
Albany New York, 12208, United States
Montefiore Medical Center
Bronx New York, 10461, United States
NYU Langone Health
New York New York, 10016, United States
Strong Memorial Hospital University of Rochester
Rochester New York, 16442, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Sanborn New York, 14132, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
The Urology Group
Cincinnati Ohio, 45212, United States
The Ohio State University- James Cancer Hospital
Columbus Ohio, 43210, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Lancaster Urology
Lancaster Pennsylvania, 17604, United States
University of Pittsburgh Medical Center - Cancer Centers
Pittsburgh Pennsylvania, 15232, United States
Urology Associates
Nashville Tennessee, 37209, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
University of Washington
Seattle Washington, 98008, United States
William S. Middleton Memorial VA
Madison Wisconsin, 53705, United States
Medical College of Wisconsin-Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Buenos Aires , C1419, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires , , Argentina
CEMIC Saavedra
Ciudad Autonoma de Buenos Aires , C1431, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de , C1199, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba , 5000, Argentina
Centro Urologico Profesor Bengio
Cordoba , X5000, Argentina
Hospital Privado de Cordoba
Cordoba , XX501, Argentina
Flinders Medical Centre
Bedford Park , 5042, Australia
St. Vincent's Hospital Sydney
Darlinghurst , 2010, Australia
Macquarie University
Macquarie University , 2109, Australia
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia
Newcastle Private Hospital
New Lambton Heights , 2305, Australia
ICON Cancer Care
South Brisbane , 4101, Australia
Sydney Adventist Hospital
Wahroonga , 2076, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Cliniques Universitaires Saint Luc
Brussel , 1200, Belgium
AZ Maria Middelares
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
CHU Sart-Tilman
Liege , 4000, Belgium
Algemeen Ziekenhuis Delta
Roeselare , 8800, Belgium
Hospital Erasto Gaertner
Curitiba , 81520, Brazil
Oncocentro Ceará
Fortaleza , 60135, Brazil
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
Goiânia , 74605, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59075, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Hospital Nossa Senhora da Conceicao S.A
Porto Alegre , 91350, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife , 50070, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto
Ribeirão Preto , 14048, Brazil
Oncoclínicas Rio de Janeiro S.A.
Rio de Janeiro , 22250, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo Andre , 09060, Brazil
Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo
Sao Paulo , 01246, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
Sao Paulo , 04039, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo , 01308, Brazil
Nanjing Drum Tower Hospital
Nanjing , 21000, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai , 20024, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43003, China
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Krajská nemocnice Liberec
Liberec , 460 6, Czechia
Urologicka klinika FNOL
Olomouc , 775 2, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Fakultni nemocnice v Motole
Praha 5 , 150 0, Czechia
Hôpital Pellegrin CHU Bordeaux
Bordeaux , 33076, France
CHU Gabriel-Montpied
Clermont Ferrand , 63000, France
Hopital Huriez
Lille , 59037, France
Hôpital Edouard Herriot
Lyon Cedex 03 , 69437, France
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
Hôpital Universitaire Pitié-Salpêtrière
Paris , 75013, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris , 75020, France
Hopital Bichat Claude Bernard
Paris , 75877, France
CHU De Poitiers
Poitiers , 86021, France
Chu Rennes - Hopital Pontchaillou
Rennes Cedex , 35033, France
Hopital Charles Nicolle
Rouen , 76031, France
CHP Saint Gregoire
Saint Gregoire , 35760, France
Hopitaux du Leman - Site Georges Pianta
Thonon-Les-Bains , 74200, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31000, France
Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy Cedex , 54519, France
Gustave Roussy
Villejuif Cedex , 94800, France
GFO Kliniken Rhein Berg
Bergisch-Gladbach , 51465, Germany
Urologicum Duisburg
Duisburg , 47169, Germany
Praxis Dr. med. Stefan Carl
Emmendingen , 79312, Germany
Klinikum Herne - Urologie
Herne , 44625, Germany
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck , 23538, Germany
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
Muenchen , 81675, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Praxisklinik Urologie Rhein/Ruhr - Germany
Mülheim an der Ruhr , 45468, Germany
MVZ Urologie 24 gGmbH
Nuernberg , 90491, Germany
Studienpraxis Urologie Drs. Feyerabend
Nuertingen , 72622, Germany
CUROS - Uberörtliche urologische Gemeinschaftspraxis
Wesseling , 50389, Germany
Health Care Global Enterprises pvt Ltd
Bangalore , 56002, India
S.P.Medical College & AG of Hospitals
Bikaner , 33400, India
Rajiv Gandhi Cancer Institute & Research Centre
Delhi , 11008, India
Health Care Global Enterprises
Jaipur , 30202, India
Tata Medical Center
Kolkata , 70016, India
King George's Medical University
Lucknow , 22600, India
Meenakshi Mission Hospital and Research Center
Madhurai , 62510, India
Tata Memorial Hospital
Mumbai , 40001, India
Muljibhai Patel Urological Hospital
Nadiad , 38700, India
CIMET's Inamdar Multispeciality Hospital
Pune , 41104, India
Ente Ecclesiastico Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti , 70021, Italy
Ospedale Regionale Umberto Parini
Aosta , 11100, Italy
Fondazione Istituto G. Giglio
Cefalu , 90015, Italy
Ospedale Civile di Guastalla
Guastalla , 42016, Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce , 73100, Italy
UOC Oncologia Ospedale Provinciale di Macerata
Macerata , 62100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
IRCCS Ospedale San Raffaele
Milan , 20132, Italy
Humanitas Centro Catanese di Oncologia
Misterbianco/Catania , 95045, Italy
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
Napoli , 80138, Italy
Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona , 37126, Italy
Juntendo University Hospital
Bunkyo-Ku , 113-8, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-Ku , 113-8, Japan
Asahi General Hospital
Chiba , 289-2, Japan
Hakodate Goryokaku Hospital
Hakodate , 040-8, Japan
Saitama Medical University International Medical Center
Hidaka , 350-1, Japan
Hitachi General Hospital
Hitachi , 317-0, Japan
St.Marianna University Hospital
Kanagawa , 216-8, Japan
Nagoya University Hospital
Nagoya , 466-8, Japan
JOHAS Osaka Rosai Hospital
Osaka , 591-8, Japan
Gunma Prefectural Cancer Center
Ota , 373-8, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki , 569-8, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Fujita Health University Hospital
Toyoake , 470-1, Japan
University of Tsukuba Hospital
Tsukuba-City , 305-8, Japan
Yokohama City University Medical Center
Yokohama , 232-0, Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chungbuk National University Hospital
Cheongju , 361-7, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdańsk , 80-21, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
CRC Sp. z o.o.
Poznan , 60-84, Poland
Kliniczny Szpital Wojewodzki nr 1 w Rzeszowie
Rzeszow , 35-05, Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin , 70-11, Poland
City Clinic Sp. z o.o.
Warszawa , 02-47, Poland
Medical Concierge Centrum Medyczne
Warszawa , 02-79, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw , 50-55, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw , 53-41, Poland
Fundacion Puigvert
Barcelona , 08025, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 8036, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Corporacio Sanitari Parc Tauli
Sabadell , 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan County , 33305, Taiwan
Royal Surrey County Hospital NHS Trust
Guildford , GU2 7, United Kingdom
University College London Hospitals
London , NW1 2, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester , M20 4, United Kingdom
South Tees Hospital NHS Foundation Trust-The James Cook University Hospital
Middlesborough , TS4 3, United Kingdom
Universirty of Sheffield Teaching Hospitals NHS Trust
Sheffield , S10 2, United Kingdom
Lister Hospital
Stevenage , SG1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

105

Study ID:

NCT04172675

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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