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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT04172675

Studienbeginn:
Februar 2020

Letztes Update:
19.07.2021

Wirkstoff:
Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations
(3 von 176)

GFO Kliniken Rhein Berg
51465 Bergisch-Gladbach
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Urologicum Duisburg
47179 Duisburg
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Praxis Dr. med. Stefan Carl
79312 Emmendingen
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Klinikum Herne - Urologie
44625 Herne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Schleswig Holstein Campus Lübeck
23538 Lubeck
(Schleswig-Holstein)
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Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
81675 Muenchen
(Bayern)
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Universitaetsklinikum Muenster
48149 Muenster
(Nordrhein-Westfalen)
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Praxisklinik Urologie Rhein/Ruhr - Germany
45468 Mülheim an der Ruhr
(Nordrhein-Westfalen)
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MVZ Urologie 24 gGmbH
90491 Nuernberg
(Bayern)
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Studienpraxis Urologie Drs. Feyerabend
72622 Nuertingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
CUROS - Uberörtliche urologische Gemeinschaftspraxis
50389 Wesseling
(Nordrhein-Westfalen)
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Urological Associates of Southern Arizona, P.C.
85741 Tucson
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USC Institute of Urology
90033 Los Angeles
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The Urology Center of Colorado
80211 Denver
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Foothills Urology - Golden Off
80401-5027 Golden
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Urological Research Network
33016 Hialeah
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Tampa General Hospital
33578 Tampa
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Emory University - Winship Cancer Institute
30322 Atlanta
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Northwestern University
60611 Chicago
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Simmons Cancer Institute
62702 Springfield
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University of Kentucky
40536 Lexington
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LSU Healthcare Network
70006 Metairie
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University of Missouri
65212 Columbia
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Montefiore Medical Center
10461 Bronx
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NYU Langone Health
10016 New York
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Strong Memorial Hospital University of Rochester
16442 Rochester
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Great Lakes Physician PC d/b/a Western New York Urology Associates
14132 Sanborn
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Levine Cancer Institute
28204 Charlotte
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The Urology Group
45212 Cincinnati
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The Ohio State University- James Cancer Hospital
43210 Columbus
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Oregon Health & Science University
97239 Portland
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University of Pittsburgh Medical Center - Cancer Centers
15232 Pittsburgh
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UT Southwestern Medical Center
75390-8565 Dallas
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University of Washington
98008 Seattle
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William S. Middleton Memorial VA
53705 Madison
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Medical College of Wisconsin-Froedtert Hospital
53226 Milwaukee
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Hospital Sirio Libanes
C1419AHN Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Hospital Britanico de Buenos Aires
Buenos Aires
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CEMIC Saavedra
C1431FWN Ciudad Autonoma de Buenos Aires
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C1199ABB Ciudad Autonoma de
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Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
5000 Cordoba
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Centro Urologico Profesor Bengio
X5000KPH Cordoba
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Hospital Privado de Cordoba
XX5016KEH Cordoba
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Flinders Medical Centre
5042 Bedford Park
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St. Vincent's Hospital Sydney
2010 Darlinghurst
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Macquarie University
2109 Macquarie University
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Peter MacCallum Cancer Centre
3000 Melbourne
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Newcastle Private Hospital
2305 New Lambton Heights
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2076 Wahroonga
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4102 Woolloongabba
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Cliniques Universitaires Saint Luc
1200 Brussel
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81520-060 Curitiba
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Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
74605-070 Goiânia
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59075-740 Natal
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Irmandade da Santa Casa de Misericordia de Porto Alegre
90050170 Porto Alegre
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91410-330 Porto Alegre
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Instituto de Medicina Integral Professor Fernando Figueira
50070-550 Recife
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Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto
14048 900 Ribeirão Preto
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Centro de Tratamento de Tumores Botafogo - CTTB
22250-905 Rio de Janeiro
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22793-080 Rio de Janeiro
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Faculdade de Medicina Do Abc
09060-650 Santo André
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Instituto do Cancer do Estado de Sao Paulo ICESP
01246-000 Sao Paulo
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04039-004 Sao Paulo
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01308-050 São Paulo
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Fudan University Shanghai Cancer Center
200032 Shanghai
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Renji Hospital, Shanghai Jiaotong University School of Medicine
200240 Shanghai
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Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
430030 Wuhan
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Fakultni nemocnice u sv. Anny v Brne
656 91 Brno
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128 08 Praha 2
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Fakultni nemocnice v Motole
150 06 Praha 5
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Hôpital Pellegrin CHU Bordeaux
33076 Bordeaux
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CHU Gabriel-Montpied
63000 Clermont Ferrand
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Hôpital Edouard Herriot
69437 Lyon Cedex 03
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Institut Paoli Calmettes
13273 Marseille Cedex 9
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Hôpital Universitaire Pitié-Salpêtrière
75013 Paris
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Groupe Hospitalier Diaconesses Croix Saint Simon
75020 Paris
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Chu Rennes - Hopital Pontchaillou
35033 Rennes Cedex
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Institut Universitaire du Cancer Toulouse Oncopole
31000 Toulouse
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Centre Hospitalier Universitaire de Nancy - Hôpital Central
54519 Vandœuvre-lès-Nancy Cedex
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Gustave Roussy
94800 Villejuif Cedex
FranceNoch nicht rekrutierend» Google-Maps
Health Care Global Enterprises pvt Ltd
560027 Bangalore
IndiaNoch nicht rekrutierend» Google-Maps
Rajiv Gandhi Cancer Institute & Research Centre
110085 Delhi
IndiaNoch nicht rekrutierend» Google-Maps
Tata Medical Center
700160 Kolkata
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Meenakshi Mission Hospital and Research Center
625107 Madhurai
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Tata Memorial Hospital
400012 Mumbai
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Muljibhai Patel Urological Hospital
387001 Nadiad
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CIMET's Inamdar Multispeciality Hospital
411040 Pune
IndiaNoch nicht rekrutierend» Google-Maps
Generale Regionale F. Miulli
70021 Acquaviva delle Fonti
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Ospedale Regionale Umberto Parini
11100 Aosta
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Ospedale Civile di Guastalla
42016 Guastalla
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Azienda Ospedaliera ''Vito Fazzi''
73100 Lecce
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UOC Oncologia Ospedale Provinciale di Macerata
62100 Macerata
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Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
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IRCCS Ospedale San Raffaele
20132 Milan
ItalyNoch nicht rekrutierend» Google-Maps
Humanitas Centro Catanese di Oncologia
95045 Misterbianco/Catania
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Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
80138 Napoli
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Azienda Ospedaliera Universitaria Integrata Verona
37126 Verona
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Juntendo University Hospital
113-8431 Bunkyo-Ku
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Tokyo Medical and Dental University Medical Hospital
113-8519 Bunkyo-Ku
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Hakodate Goryokaku Hospital
040-8611 Hakodate
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Saitama Medical University International Medical Center
350-1298 Hidaka
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St.Marianna University School of Medicine
216-8511 Kanagawa
JapanNoch nicht rekrutierend» Google-Maps
Nagoya University Hospital
466-8560 Nagoya
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Gunma Prefectural Cancer Center
373-8550 Ota
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Osaka Medical and Pharmaceutical University Hospital
569-8686 Takatsuki
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The Cancer Institute Hospital of JFCR
135-8550 Tokyo
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Fujita Health University Hospital
470-1192 Toyoake
JapanNoch nicht rekrutierend» Google-Maps
University of Tsukuba Hospital
305-8576 Tsukuba-City
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Yokohama City University Medical Center
232-0024 Yokohama
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Pusan National University Hospital.
49241 Busan
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Chungbuk National University Hospital
361-711 Cheongju
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Kyungpook National University Chilgok Hospital
41404 Daegu
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National Cancer Center
10408 Goyang-si
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Chonnam National University Hwasun Hospital
58128 Jeollanam-do
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Korea University Medical Center (KUMC) - Korea University Anam Hospital
02841 Seoul
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Seoul National University Hospital
03080 Seoul
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Kangbuk Samsung Hospital
03181 Seoul
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Severance Hospital, Yonsei University Health System
03722 Seoul
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Samsung Medical Center
06351 Seoul
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Uniwersyteckie Centrum Kliniczne
80-214 Gdańsk
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Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
93-513 Lodz
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Kliniczny Szpital Wojewodzki nr 1 w Rzeszowie
35-055 Rzeszow
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Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
70-111 Szczecin
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Medical Concierge Centrum Medyczne
02-798 Warszawa
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Uniwersytecki Szpital Kliniczny
50-556 Wroclaw
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Dolnoslaskie Centrum Onkologii
53-413 Wroclaw
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Hosp. Clinic I Provincial de Barcelona
8036 Barcelona
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Corporacio Sanitari Parc Tauli
08208 Sabadell
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Hosp. Univ. Marques de Valdecilla
39008 Santander
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Instituto Valenciano de Oncologia
46009 Valencia
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Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
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China Medical University Hospital
40447 Taichung
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Taichung Veterans General Hospital
40705 Taichung
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National Taiwan University Hospital
10002 Taipei
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Taipei Veterans General Hospital
11217 Taipei
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Chang Gung Memorial Hospital- Linkou
33305 Taoyuan County
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Royal Surrey County Hospital NHS Trust
GU2 7XX Guildford
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NW1 2BU London
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The Christie NHS Foundation Trust - Christie Hospital
M20 4BX Manchester
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TS4 3BW Middlesborough
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Universirty of Sheffield Teaching Hospitals NHS Trust
S10 2JF Sheffield
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Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Recurrence-Free Survival (RFS) (Time Frame - Up to 4 years):
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:

1. Time to Disease Worsening (Time Frame - Up to 4 years):
Time from the date of randomization to the date of first documented evidence of cystectomy, change in therapy indicative of more advanced disease (including systemic chemotherapy or radiotherapy). Participants who are free of disease worsening and alive or have unknown status will be censored at the last tumor assessment.

2. Time to Progression (Time Frame - Up to 4 years):
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.

3. Disease-Specific Survival (Time Frame - Up to 4 years):
The time from the date of randomization to the date of the participant's death resulting from bladder cancer. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive. Participants whose death result from causes other than bladder cancer will be censored at their death dates.

4. Overall Survival (Time Frame - Up to 4 years):
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.

5. Recurrence-Free Survival (Time Frame - Months 6, 12, and 24):
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.

6. Recurrence-Free Survival 2 (RFS2) (Time Frame - Up to 4 years):
RFS2 is defined as the time from the date of randomization until the date of the reappearance of high-risk disease on the first subsequent non-surgical anticancer treatment, or death, whichever is reported first.

7. RFS by Central Histopathologic Review (Time Frame - Up to 4 years):
RFS will be assessed by central histopathologic review. 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.

8. Plasma Concentration of Erdafitinib (Time Frame - Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28 days)):
Plasma concentration of erdafitinib will be reported.

9. Number of Participants with Adverse events (Time Frame - Up to 4 years):
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

10. Change from Baseline in Patient's Global Impression of Severity (of cancer) (PGIS) (Time Frame - Baseline up to 4 years):
PGIS is single-item questionnaires to evaluate patient's global impression of severity.

11. Change from Baseline in Patient's Global Impression of Change (of cancer) (PGIC) (Time Frame - Baseline, Cycle 2 Day 1 and end of treatment (up to 2 years) (each cycle is of 28 days)):
PGIC is single-item questionnaires to evaluate a patient's global impression of change of cancer.

12. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 (Time Frame - Baseline up to 4 years):
EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

13. Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 (Time Frame - Baseline up to 4 years):
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30.

14. Change from Baseline in EuroQol European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) (Time Frame - Baseline up to 4 years):
EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression.

Studien-Arme

  • Experimental: Cohort 1: Erdafitinib
    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.
  • Active Comparator: Cohort 1: Investigators Choice
    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)/hyperthermic MMC. Participants who are randomized to gemcitabine or MMC/hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.
  • Experimental: Cohort 2
    Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.
  • Experimental: Cohort 3
    Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.

Geprüfte Regime

  • Erdafitinib (JNJ-42756493):
    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.
  • Investigator Choice (Gemcitabine):
    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.
  • Investigator Choice (Mitomycin C):
    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.

Quelle: ClinicalTrials.gov


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