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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)

Primary Purpose

Urinary Bladder Neoplasms

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erdafitinib
Investigator Choice (Gemcitabine)
Investigator Choice (Mitomycin C)
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Non muscle invasive bladder cancer (NMIBC), Bacillus calmette- guerin (BCG) failure, BCG unresponsive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Urological Associates of Southern Arizona, P.C.
  • USC Institute of Urology
  • The Urology Center of Colorado
  • Urological Research Network
  • Emory University - Winship Cancer Institute
  • Northwestern University
  • Simmons Cancer Institute
  • University of Kansas
  • Albany Medical College
  • Montefiore Medical Center
  • NYU Langone Health
  • Great Lakes Physician PC d/b/a Western New York Urology Associates
  • Levine Cancer Institute
  • The Urology Group
  • The Ohio State University- James Cancer Hospital
  • Oregon Health & Science University
  • MidLantic Urology
  • University of Pittsburgh Medical Center - Cancer Centers
  • Urology Associates
  • UT Southwestern Medical Center
  • University of Washington
  • Medical College of Wisconsin-Froedtert Hospital
  • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • Hospital Britanico de Buenos Aires
  • CEMIC Saavedra
  • Hospital Italiano de Buenos Aires
  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Centro Urologico Profesor Bengio
  • Hospital Privado de Cordoba
  • Flinders Medical Centre
  • St. Vincent's Hospital Sydney
  • Macquarie University
  • Peter MacCallum Cancer Centre
  • AZ Maria Middelares
  • UZ Leuven
  • CHU Sart-Tilman
  • Algemeen Ziekenhuis Delta
  • Liga Paranaense de Combate ao Cancer
  • Oncocentro Ceará
  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Liga Norte Riograndense Contra O Cancer
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital Nossa Senhora da Conceicao S.A
  • Instituto de Medicina Integral Professor Fernando Figueira
  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
  • Oncoclínicas Rio de Janeiro S.A.
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
  • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • Nanjing Drum Tower Hospital
  • Fudan University Shanghai Cancer Center
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Fakultni nemocnice u sv. Anny v Brne
  • Krajská nemocnice Liberec
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice v Motole
  • Hopital Pellegrin CHU Bordeaux
  • CHU Gabriel-Montpied
  • Hopital Huriez
  • Hôpital Edouard Herriot
  • Institut Paoli Calmettes
  • Hôpital Universitaire Pitié-Salpêtrière
  • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Hopital Bichat Claude Bernard
  • CHU De Poitiers
  • Chu Rennes - Hopital Pontchaillou
  • Hopital Charles Nicolle
  • CHP Saint Gregoire
  • Institut Universitaire du Cancer Toulouse Oncopole
  • Centre Hospitalier Universitaire de Nancy - Hôpital Central
  • Gustave Roussy
  • Urologicum Duisburg
  • Klinikum Herne - Urologie
  • Universitätsklinikum Schleswig Holstein Campus Lübeck
  • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
  • Universitaetsklinikum Muenster
  • Praxisklinik Urologie Rhein/Ruhr - Germany
  • MVZ Urologie 24 gGmbH
  • Studienpraxis Urologie Drs. Feyerabend
  • CUROS - Uberörtliche urologische Gemeinschaftspraxis
  • Health Care Global Enterprises pvt Ltd
  • Rajiv Gandhi Cancer Institute & Research Centre
  • King George's Medical University
  • Meenakshi Mission Hospital and Research Center
  • Muljibhai Patel Urological Hospital
  • CIMET's Inamdar Multispeciality Hospital
  • Ente Ecclesiastico Ospedale Generale Regionale F. Miulli
  • Ospedale Regionale Umberto Parini
  • Fondazione Istituto G. Giglio
  • Ospedale Civile di Guastalla
  • Azienda Ospedaliera ''Vito Fazzi''
  • UOC Oncologia Ospedale Provinciale di Macerata
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IRCCS Ospedale San Raffaele
  • Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
  • Azienda Ospedaliera Sant Andrea
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Juntendo University Hospital
  • Tokyo Medical and Dental University Hospital
  • Asahi General Hospital
  • Hakodate Goryokaku Hospital
  • Saitama Medical University International Medical Center
  • Hitachi General Hospital
  • St.Marianna University Hospital
  • Nagoya University Hospital
  • JOHAS Osaka Rosai Hospital
  • Gunma Prefectural Cancer Center
  • Osaka Medical and Pharmaceutical University Hospital
  • Toranomon Hospital
  • The Cancer Institute Hospital of JFCR
  • Fujita Health University Hospital
  • University of Tsukuba Hospital
  • Yokohama City University Medical Center
  • Pusan National University Hospital
  • Chungbuk National University Hospital
  • Kyungpook National University Chilgok Hospital
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • Pratia MCM Krakow
  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
  • City Clinic Sp. z o.o.
  • Medical Concierge Centrum Medyczne
  • Uniwersytecki Szpital Kliniczny
  • Fundacion Puigvert
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. La Paz
  • Corporacio Sanitari Parc Tauli
  • Hosp. Univ. Marques de Valdecilla
  • Instituto Valenciano de Oncologia
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital- Linkou
  • The Christie NHS Foundation Trust - Christie Hospital
  • Universirty of Sheffield Teaching Hospitals NHS Trust
  • Lister Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Cohort 1: Erdafitinib

Cohort 1: Investigators Choice

Cohort 2

Cohort 3

Arm Description

Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.

Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.

Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.

Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.

Outcomes

Primary Outcome Measures

Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first.

Secondary Outcome Measures

Time to Progression
Time from the date of randomization until the date of first documented evidence of any of progression or death. Participants who are progression -free and alive or have unknown status will be censored at the date of the last tumor assessment.
Overall Survival
The time from the date of randomization to the date of the participant's death resulting from any cause. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive.
Recurrence-Free Survival
RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first. Participants who are recurrence-free and alive or have unknown status will be censored at the last tumor assessment.
Plasma Concentration of Erdafitinib
Plasma concentration of erdafitinib will be reported.
Number of Participants with Adverse events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product

Full Information

First Posted
November 20, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04172675
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
Keywords
Non muscle invasive bladder cancer (NMIBC), Bacillus calmette- guerin (BCG) failure, BCG unresponsive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Erdafitinib
Arm Type
Experimental
Arm Description
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.
Arm Title
Cohort 1: Investigators Choice
Arm Type
Active Comparator
Arm Description
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.
Intervention Type
Drug
Intervention Name(s)
Erdafitinib
Other Intervention Name(s)
JNJ-42756493
Intervention Description
Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.
Intervention Type
Drug
Intervention Name(s)
Investigator Choice (Gemcitabine)
Intervention Description
Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
Intervention Type
Drug
Intervention Name(s)
Investigator Choice (Mitomycin C)
Intervention Description
Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Time from the date of randomization until the date of first documented evidence of any of progression or death. Participants who are progression -free and alive or have unknown status will be censored at the date of the last tumor assessment.
Time Frame
Up to 4 years
Title
Overall Survival
Description
The time from the date of randomization to the date of the participant's death resulting from any cause. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive.
Time Frame
Up to 4 years
Title
Recurrence-Free Survival
Description
RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first. Participants who are recurrence-free and alive or have unknown status will be censored at the last tumor assessment.
Time Frame
Months 6 and 12
Title
Plasma Concentration of Erdafitinib
Description
Plasma concentration of erdafitinib will be reported.
Time Frame
Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28 days)
Title
Number of Participants with Adverse events
Description
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-human chorionic gonadotropin [beta-hCG]) (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Urological Associates of Southern Arizona, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
USC Institute of Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Simmons Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Kansas
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Great Lakes Physician PC d/b/a Western New York Urology Associates
City
Sanborn
State/Province
New York
ZIP/Postal Code
14132
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
The Ohio State University- James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pittsburgh Medical Center - Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98008
Country
United States
Facility Name
Medical College of Wisconsin-Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
CEMIC Saavedra
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1431FWN
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Centro Urologico Profesor Bengio
City
Cordoba
ZIP/Postal Code
X5000KPH
Country
Argentina
Facility Name
Hospital Privado de Cordoba
City
Cordoba
ZIP/Postal Code
XX5016KEH
Country
Argentina
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Macquarie University
City
Macquarie University
ZIP/Postal Code
2109
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Oncocentro Ceará
City
Fortaleza
ZIP/Postal Code
60135-237
Country
Brazil
Facility Name
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao S.A
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Instituto de Medicina Integral Professor Fernando Figueira
City
Recife
ZIP/Postal Code
50070-550
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
City
Ribeirão Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-901
Country
Brazil
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Krajská nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hopital Pellegrin CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Gabriel-Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Hôpital Universitaire Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hopital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
CHU De Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHP Saint Gregoire
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy - Hôpital Central
City
Vandœuvre-lès-Nancy Cedex
ZIP/Postal Code
54519
Country
France
Facility Name
Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94800
Country
France
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47169
Country
Germany
Facility Name
Klinikum Herne - Urologie
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Universitätsklinikum Schleswig Holstein Campus Lübeck
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Praxisklinik Urologie Rhein/Ruhr - Germany
City
Mülheim an der Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
MVZ Urologie 24 gGmbH
City
Nuernberg
ZIP/Postal Code
90491
Country
Germany
Facility Name
Studienpraxis Urologie Drs. Feyerabend
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
CUROS - Uberörtliche urologische Gemeinschaftspraxis
City
Wesseling
ZIP/Postal Code
50389
Country
Germany
Facility Name
Health Care Global Enterprises pvt Ltd
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
Rajiv Gandhi Cancer Institute & Research Centre
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
King George's Medical University
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Name
Meenakshi Mission Hospital and Research Center
City
Madhurai
ZIP/Postal Code
625107
Country
India
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiad
ZIP/Postal Code
387001
Country
India
Facility Name
CIMET's Inamdar Multispeciality Hospital
City
Pune
ZIP/Postal Code
411040
Country
India
Facility Name
Ente Ecclesiastico Ospedale Generale Regionale F. Miulli
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Facility Name
Ospedale Regionale Umberto Parini
City
Aosta
ZIP/Postal Code
11100
Country
Italy
Facility Name
Fondazione Istituto G. Giglio
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Ospedale Civile di Guastalla
City
Guastalla
ZIP/Postal Code
42016
Country
Italy
Facility Name
Azienda Ospedaliera ''Vito Fazzi''
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
UOC Oncologia Ospedale Provinciale di Macerata
City
Macerata
ZIP/Postal Code
62100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliera Sant Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Juntendo University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Asahi General Hospital
City
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Hakodate Goryokaku Hospital
City
Hakodate
ZIP/Postal Code
040-8611
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
JOHAS Osaka Rosai Hospital
City
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba-City
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-711
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-727
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
City Clinic Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-473
Country
Poland
Facility Name
Medical Concierge Centrum Medyczne
City
Warszawa
ZIP/Postal Code
02-798
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital- Linkou
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
The Christie NHS Foundation Trust - Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Universirty of Sheffield Teaching Hospitals NHS Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
34125951
Citation
Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.
Results Reference
derived

Learn more about this 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)

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