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Brief Title: 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

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

INTRODUCTION

  • Org Study ID: CR108699
  • Secondary ID: 2019-002449-39, 42756493BLC2003
  • NTC ID: NCT04172675
  • Sponsor: Janssen Research & Development, LLC
To learn how to participate in this trial please click here.

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

  • Overall Status
    Recruiting
  • Start Date
    February 28, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence-Free Survival (RFS)

Primary Outcome 1 - Timeframe: Up to 4 years

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

LOCATION

Facility Status Contact
Facility: Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85741
United States
Status: Recruiting Contact: N/A
Facility: USC Institute of Urology
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: The Urology Center of Colorado
Denver, Colorado 80211
United States
Status: Recruiting Contact: N/A
Facility: Urological Research Network
Hialeah, Florida 33016
United States
Status: Recruiting Contact: N/A
Facility: Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Simmons Cancer Institute
Springfield, Illinois 62702
United States
Status: Recruiting Contact: N/A
Facility: University of Kansas
Westwood, Kansas 66205
United States
Status: Recruiting Contact: N/A
Facility: Albany Medical College
Albany, New York 12208
United States
Status: Recruiting Contact: N/A
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: N/A
Facility: Great Lakes Physician PC d/b/a Western New York Urology Associates
Sanborn, New York 14132
United States
Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: N/A
Facility: The Urology Group
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: N/A
Facility: The Ohio State University- James Cancer Hospital
Columbus, Ohio 43210
United States
Status: Recruiting Contact: N/A
Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: University of Pittsburgh Medical Center - Cancer Centers
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: UT Southwestern Medical Center
Dallas, Texas 75390-8565
United States
Status: Recruiting Contact: N/A
Facility: University of Washington
Seattle, Washington 98008
United States
Status: Recruiting Contact: N/A
Facility: Medical College of Wisconsin-Froedtert Hospital
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: N/A
Facility: Hospital Sirio Libanes
Buenos Aires, C1419AHN
Argentina
Status: Recruiting Contact: N/A
Facility: CEMIC Saavedra
Ciudad Autonoma de Buenos Aires, C1199ABB
Argentina
Status: Recruiting Contact: N/A
Facility: Hospital Italiano de Buenos Aires
Ciudad Autonoma de, 5000
Argentina
Status: Recruiting Contact: N/A
Facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba, X5000KPH
Argentina
Status: Recruiting Contact: N/A
Facility: Centro Urologico Profesor Bengio
Cordoba, XX5016KEH
Argentina
Status: Recruiting Contact: N/A
Facility: Hospital Privado de Cordoba
Cordoba, 5042
Argentina
Status: Recruiting Contact: N/A
Facility: Flinders Medical Centre
Bedford Park, 2010
Australia
Status: Recruiting Contact: N/A
Facility: St. Vincent's Hospital Sydney
Darlinghurst, 2109
Australia
Status: Recruiting Contact: N/A
Facility: Macquarie University
Macquarie University, 3000
Australia
Status: Recruiting Contact: N/A
Facility: Peter MacCallum Cancer Centre
Melbourne, 2305
Australia
Status: Recruiting Contact: N/A
Facility: AZ Maria Middelares
Gent, 3000
Belgium
Status: Recruiting Contact: N/A
Facility: UZ Leuven
Leuven, 4000
Belgium
Status: Recruiting Contact: N/A
Facility: CHU Sart-Tilman
Liege, 8800
Belgium
Status: Recruiting Contact: N/A
Facility: Algemeen Ziekenhuis Delta
Roeselare, 81520-060
Belgium
Status: Recruiting Contact: N/A
Facility: Hospital Erasto Gaertner
Curitiba, 60135-237
Brazil
Status: Recruiting Contact: N/A
Facility: Oncocentro Ceará
Fortaleza, 74605-070
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
Goiânia, 59075-740
Brazil
Status: Recruiting Contact: N/A
Facility: Liga Norte Riograndense Contra O Cancer
Natal, 90050170
Brazil
Status: Recruiting Contact: N/A
Facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 91410-330
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Nossa Senhora da Conceicao
Porto Alegre, 50070-550
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto de Medicina Integral Professor Fernando Figueira
Recife, 14048 900
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto
Ribeirão Preto, 22250-905
Brazil
Status: Recruiting Contact: N/A
Facility: Centro de Tratamento de Tumores Botafogo - CTTB
Rio de Janeiro, 22793-080
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto COI de Pesquisa, Educacao e Gestao
Rio de Janeiro, 09060-650
Brazil
Status: Recruiting Contact: N/A
Facility: Faculdade de Medicina Do Abc
Santo André, 01246-000
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto do Cancer do Estado de Sao Paulo ICESP
Sao Paulo, 04039-004
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Do Servidor Publico Estadual
Sao Paulo, 01308-050
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Sirio Libanes
São Paulo, 210008
Brazil
Status: Recruiting Contact: N/A
Facility: Nanjing Drum Tower Hospital
Nanjing, 200032
China
Status: Recruiting Contact: N/A
Facility: Fudan University Shanghai Cancer Center
Shanghai, 200240
China
Status: Recruiting Contact: N/A
Facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 430030
China
Status: Recruiting Contact: N/A
Facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 656 91
China
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice u sv. Anny v Brne
Brno, 460 63
Czechia
Status: Recruiting Contact: N/A
Facility: Krajská nemocnice Liberec
Liberec, 775 20
Czechia
Status: Recruiting Contact: N/A
Facility: Vseobecna fakultni nemocnice v Praze
Praha 2, 150 06
Czechia
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice v Motole
Praha 5, 33076
Czechia
Status: Recruiting Contact: N/A
Facility: Hôpital Pellegrin CHU Bordeaux
Bordeaux, 63000
France
Status: Recruiting Contact: N/A
Facility: CHU Gabriel-Montpied
Clermont Ferrand, 59037
France
Status: Recruiting Contact: N/A
Facility: Hopital Huriez
Lille, 69437
France
Status: Recruiting Contact: N/A
Facility: Hôpital Edouard Herriot
Lyon Cedex 03, 13273
France
Status: Recruiting Contact: N/A
Facility: Institut Paoli Calmettes
Marseille Cedex 9, 75013
France
Status: Recruiting Contact: N/A
Facility: Hôpital Universitaire Pitié-Salpêtrière
Paris, 75020
France
Status: Recruiting Contact: N/A
Facility: Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75877
France
Status: Recruiting Contact: N/A
Facility: Hopital Bichat Claude Bernard
Paris, 86021
France
Status: Recruiting Contact: N/A
Facility: CHU De Poitiers
Poitiers, 35033
France
Status: Recruiting Contact: N/A
Facility: Chu Rennes - Hopital Pontchaillou
Rennes Cedex, 76031
France
Status: Recruiting Contact: N/A
Facility: Hopital Charles Nicolle
Rouen, 35760
France
Status: Recruiting Contact: N/A
Facility: CHP Saint Gregoire
Saint Gregoire, 31000
France
Status: Recruiting Contact: N/A
Facility: Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 54519
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy Cedex, 94800
France
Status: Recruiting Contact: N/A
Facility: Urologicum Duisburg
Duisburg, 79312
Germany
Status: Recruiting Contact: N/A
Facility: Klinikum Herne - Urologie
Herne, 23538
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck, 81675
Germany
Status: Recruiting Contact: N/A
Facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
Muenchen, 48149
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Muenster
Muenster, 45468
Germany
Status: Recruiting Contact: N/A
Facility: Praxisklinik Urologie Rhein/Ruhr - Germany
Mülheim an der Ruhr, 90491
Germany
Status: Recruiting Contact: N/A
Facility: MVZ Urologie 24 gGmbH
Nuernberg, 72622
Germany
Status: Recruiting Contact: N/A
Facility: Studienpraxis Urologie Drs. Feyerabend
Nuertingen, 50389
Germany
Status: Recruiting Contact: N/A
Facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis
Wesseling, 560027
Germany
Status: Recruiting Contact: N/A
Facility: Rajiv Gandhi Cancer Institute & Research Centre
Delhi, 700160
India
Status: Recruiting Contact: N/A
Facility: Muljibhai Patel Urological Hospital
Nadiad, 411040
India
Status: Recruiting Contact: N/A
Facility: CIMET's Inamdar Multispeciality Hospital
Pune, 70021
India
Status: Recruiting Contact: N/A
Facility: Generale Regionale F. Miulli
Acquaviva delle Fonti, 11100
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Regionale Umberto Parini
Aosta, 90015
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione Istituto G. Giglio
Cefalu, 42016
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Civile di Guastalla
Guastalla, 73100
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera ''Vito Fazzi''
Lecce, 62100
Italy
Status: Recruiting Contact: N/A
Facility: UOC Oncologia Ospedale Provinciale di Macerata
Macerata, 20133
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20132
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
Napoli, 00189
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Sant Andrea
Roma, 37126
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Universitaria Integrata Verona
Verona, 113-8431
Italy
Status: Recruiting Contact: N/A
Facility: Juntendo University Hospital
Bunkyo-Ku, 113-8519
Japan
Status: Recruiting Contact: N/A
Facility: Tokyo Medical and Dental University Medical Hospital
Bunkyo-Ku, 289-2511
Japan
Status: Recruiting Contact: N/A
Facility: Asahi General Hospital
Chiba, 040-8611
Japan
Status: Recruiting Contact: N/A
Facility: Hakodate Goryokaku Hospital
Hakodate, 350-1298
Japan
Status: Recruiting Contact: N/A
Facility: Hitachi General Hospital
Hitachi, 216-8511
Japan
Status: Recruiting Contact: N/A
Facility: St.Marianna University School of Medicine
Kanagawa, 466-8560
Japan
Status: Recruiting Contact: N/A
Facility: JOHAS Osaka Rosai Hospital
Osaka, 373-8550
Japan
Status: Recruiting Contact: N/A
Facility: Gunma Prefectural Cancer Center
Ota, 569-8686
Japan
Status: Recruiting Contact: N/A
Facility: Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 105-8470
Japan
Status: Recruiting Contact: N/A
Facility: Toranomon Hospital
Tokyo, 135-8550
Japan
Status: Recruiting Contact: N/A
Facility: The Cancer Institute Hospital of JFCR
Tokyo, 470-1192
Japan
Status: Recruiting Contact: N/A
Facility: University of Tsukuba Hospital
Tsukuba-City, 232-0024
Japan
Status: Recruiting Contact: N/A
Facility: Yokohama City University Medical Center
Yokohama, 49241
Japan
Status: Recruiting Contact: N/A
Facility: Pusan National University Hospital.
Busan, 361-711
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chungbuk National University Hospital
Cheongju, 41404
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Kyungpook National University Chilgok Hospital
Daegu, 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, 58128
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chonnam National University Hwasun Hospital
Jeollanam-do, 02841
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Korea University Medical Center (KUMC) - Korea University Anam Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03181
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Kangbuk Samsung Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Severance Hospital, Yonsei University Health System
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 80-214
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Uniwersyteckie Centrum Kliniczne
Gdańsk, 30-510
Poland
Status: Recruiting Contact: N/A
Facility: Pratia MCM Krakow
Krakow, 93-513
Poland
Status: Recruiting Contact: N/A
Facility: Kliniczny Szpital Wojewodzki nr 1 w Rzeszowie
Rzeszow, 70-111
Poland
Status: Recruiting Contact: N/A
Facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin, 02-473
Poland
Status: Recruiting Contact: N/A
Facility: City Clinic Sp. z o.o.
Warszawa, 02-798
Poland
Status: Recruiting Contact: N/A
Facility: Medical Concierge Centrum Medyczne
Warszawa, 50-556
Poland
Status: Recruiting Contact: N/A
Facility: Uniwersytecki Szpital Kliniczny
Wroclaw, 53-413
Poland
Status: Recruiting Contact: N/A
Facility: Fundacion Puigvert
Barcelona, 8036
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Clinic I Provincial de Barcelona
Barcelona, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Ramon Y Cajal
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. 12 de Octubre
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. La Paz
Madrid, 08208
Spain
Status: Recruiting Contact: N/A
Facility: Corporacio Sanitari Parc Tauli
Sabadell, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Marques de Valdecilla
Santander, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Instituto Valenciano de Oncologia
Valencia, 80756
Spain
Status: Recruiting Contact: N/A
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 40447
Taiwan
Status: Recruiting Contact: N/A
Facility: China Medical University Hospital
Taichung, 40705
Taiwan
Status: Recruiting Contact: N/A
Facility: Taichung Veterans General Hospital
Taichung, 10002
Taiwan
Status: Recruiting Contact: N/A
Facility: National Taiwan University Hospital
Taipei, 11217
Taiwan
Status: Recruiting Contact: N/A
Facility: Taipei Veterans General Hospital
Taipei, 33305
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang Gung Memorial Hospital- Linkou
Taoyuan County, GU2 7XX
Taiwan
Status: Recruiting Contact: N/A
Facility: The Christie NHS Foundation Trust - Christie Hospital
Manchester, TS4 3BW
United Kingdom
Status: Recruiting Contact: N/A
Facility: Lister Hospital
Stevenage,
United Kingdom
Status: Recruiting Contact: N/A