SUPPORT HOTLINE (888) 901-2226
Donate Now

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


  • Org Study ID: CR108699
  • Secondary ID: 2019-002449-39,42756493BLC2003
  • NCT ID: NCT04172675
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: Janssen Research & Development, LLC

Description

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

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 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 Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 4 years

Condition:

  • Urinary Bladder Neoplasms

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
Show More

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: Study Contact

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

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
Not yet 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
Not yet recruiting
Tampa General Hospital
Tampa, Florida 33578
United States
Withdrawn
Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
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
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
Not yet recruiting
Albany Medical College
Albany, New York 12208
United States
Recruiting
Montefiore Medical Center
Bronx, New York 10461
United States
Not yet 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
Not yet 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
United States
Not yet recruiting
University of Washington
Seattle, Washington 98008
United States
Not yet recruiting
William S. Middleton Memorial VA
Madison, Wisconsin 53705
United States
Not yet recruiting
Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
United States
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
Not yet 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
Not yet recruiting
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
Centro de Pesquisa Urologica e Oncologia de Campinas
Campinas, 13073-400
Brazil
Not yet recruiting
Hospital Erasto Gaertner
Curitiba, 81520-060
Brazil
Not yet recruiting
Oncocentro Ceará
Fortaleza, 60135-237
Brazil
Not yet recruiting
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
Goiânia, 74605-070
Brazil
Not yet 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
Not yet recruiting
Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto
Ribeirão Preto, 14048 900
Brazil
Not yet recruiting
Centro de Tratamento de Tumores Botafogo - CTTB
Rio de Janeiro, 22250-905
Brazil
Not yet recruiting
Instituto COI de Pesquisa, Educacao e Gestao
Rio de Janeiro, 22793-080
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
Not yet 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
Not yet 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
Not yet recruiting
Hôpital Européen Georges Pompidou
France, 75015
France
Withdrawn
Hopital Huriez
Lille, 59037
France
Not yet recruiting
Hôpital Edouard Herriot
Lyon Cedex 03, 69437
France
Not yet recruiting
Institut Paoli Calmettes
Marseille Cedex 9, 13273
France
Not yet recruiting
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013
France
Not yet recruiting
Hopital Bichat Claude Bernard
Paris, 75877
France
Not yet recruiting
CHU De Poitiers
Poitiers, 86021
France
Not yet recruiting
Chu Rennes - Hopital Pontchaillou
Rennes Cedex, 35033
France
Not yet recruiting
Hopital Charles Nicolle
Rouen, 76031
France
Not yet recruiting
CHP Saint Gregoire
Saint Gregoire, 35760
France
Not yet recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31000
France
Not yet recruiting
Hopital La Croix Du Sud
Toulouse, 31130
France
Suspended
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
Not yet recruiting
Klinikum Herne - Urologie
Herne, 44625
Germany
Recruiting
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck, 23538
Germany
Not yet 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
Not yet recruiting
Studienpraxis Urologie Drs. Feyerabend
Nuertingen, 72622
Germany
Not yet recruiting
CUROS - Uberörtliche urologische Gemeinschaftspraxis
Wesseling, 50389
Germany
Recruiting
Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021
Italy
Not yet 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
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
Napoli, 80138
Italy
Not yet recruiting
Azienda Ospedaliera Sant Andrea
Roma, 00189
Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Italy
Not yet recruiting
Tokyo Medical and Dental University 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
Not yet recruiting
University of Tsukuba Hospital
Tsukuba-City, 305-8576
Japan
Recruiting
Pusan National University Hospital.
Busan, 49241
Korea, Republic of
Not yet 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
City Clinic Sp. z o.o.
Warszawa, 02-473
Poland
Not yet 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
Not yet recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 8036
Spain
Not yet 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
Not yet recruiting
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Spain
Recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Not yet 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
Not yet 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