Clinical trial • Phase III • Oncology

Erdafitinib for Non-muscle invasive bladder cancer (intermediate-risk) | FGFR gene alterations

Phase III trial of Erdafitinib for Non-muscle invasive bladder cancer (intermediate-risk) | FGFR gene alterations.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-muscle invasive bladder cancer (intermediate-risk) | FGFR gene alterations
Trial Stage
Phase III
Drug Modality
Small molecule|Small molecule|Small molecule

Key dates

Initial CTIS Submission Date
28-02-2024
First CTIS Authorization Date
11-06-2024

Trial design

Randomised, mitomycin (intravesical) and gemcitabine (intravesical); doses/schedules not specified in the ctis record-controlled, crossover Phase III trial across 77 sites in Spain, Czechia, Denmark and others.

Randomised
Yes
Comparator
MITOMYCIN (intravesical) and GEMCITABINE (intravesical); doses/schedules not specified in the CTIS record
Crossover
Yes
Biomarker Stratified
True, biomarker: FGFR mutation or fusion (susceptible FGFR alterations)
Target Sample Size
339

Eligibility

Recruits 339 Vulnerable population flag is selected. Site-specific subject information and informed consent forms (SIS and ICF) and dedicated appendices are provided (examples in document list include ICFs and privacy appendices for pregnant partners and a 'Privacy Appendix Child Exposed to IP'). Consent is obtained via site-specific ICF documents; additional consent/appendices exist for pregnancy-related issues and crossover/substudies as indicated in the documentation..

Vulnerable Population
Vulnerable population flag is selected. Site-specific subject information and informed consent forms (SIS and ICF) and dedicated appendices are provided (examples in document list include ICFs and privacy appendices for pregnant partners and a 'Privacy Appendix Child Exposed to IP'). Consent is obtained via site-specific ICF documents; additional consent/appendices exist for pregnancy-related issues and crossover/substudies as indicated in the documentation.

Inclusion criteria

  • {"criterion_text":"- Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: •\tTa LG/G1: primary or recurrent •\tTa LG/G2: primary or recurrent And ≥1 of the following risk factors: •\tMultiple Ta LG tumors •\tSolitary LG tumor ≥3 cm •\tEarly recurrence (≤1 year) •\tFrequent recurrence (>1 per year) •\tRecurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) Note: Mixed histology tumors are allowed if percentage of variant histology and subtype of variant histology are consistent with an LG tumor.\n- Have a susceptible FGFR mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing\n- Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy."}

Exclusion criteria

  • {"criterion_text":"- Histologically confirmed diagnosis of HR NMIBC (defined as HG/G2 or HG/G3 Ta and T1, or CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.\n- Has or had urothelial carcinoma outside of the urinary bladder (ie, urethra, ureter, or renal pelvis, N+, M+) or has a histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and without any evidence of disease following nephroureterectomy.\n- Received an investigational treatment for bladder cancer after TURBT for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study.\n- Received adjuvant intravesical chemotherapy within 6 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy per institutional guidelines (is not considered adjuvant therapy (and no washout period is required for this single dose).\n- Received prior treatment with an FGFR inhibitor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first","definition_or_measurement_approach":"DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first"}

Recruitment

Planned Sample Size
339
Recruitment Window Months
46
Consent Approach
Informed consent is obtained using site-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF). Multiple ICF documents and language versions are provided (country/site-specific ICFs, pregnancy ICFs, molecular eligibility ICFs, crossover addenda, and sub-study ICFs). Contact and consent procedures are managed per site with the provided SIS/ICF materials.

Geography

Total Number Of Sites
77
Total Number Of Participants
201

Spain

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
781
Number Of Sites
16
Number Of Participants
36

Sites

Site Name
Hospital Universitario De La Ribera
Department Name
Urology
Contact Person Name
Cristina Ferrandis Cortés
Contact Person Email
ferrandis_cricor@gva.es
Site Name
Clinica Universidad De Navarra
Department Name
Urology
Contact Person Name
Felipe Villacampa
Contact Person Email
fvauba@unav.es
Site Name
Fundacio Puigvert
Department Name
Urology
Contact Person Name
Oscar Rodriguez Faba
Site Name
Hospital Universitari Vall D Hebron
Department Name
Urology
Contact Person Name
Albert Carrion Puig
Contact Person Email
albert.carrion@vallhebron.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Urology
Contact Person Name
Carlos Hernandez Fernandez
Site Name
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Department Name
Urology
Contact Person Name
Antoni Vilaseca Cabo
Contact Person Email
AVILASEC@clinic.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Urology
Contact Person Name
Jose Maria Martinez Jabaloyas
Contact Person Email
marjabaloyas@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Urology
Contact Person Name
Felix Guerrero
Contact Person Email
felixguerrero@gmail.com
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Urology
Contact Person Name
Jesús Rosety Rodriguez
Contact Person Email
jesusr81@hotmail.com
Site Name
Hospital General Universitario De Castellon
Department Name
Urology
Contact Person Name
Miguel Rodrigo
Contact Person Email
m-rodrigo@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Urology
Contact Person Name
Sara Martinez Breijo
Contact Person Email
smarbre@hotmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Urology
Contact Person Name
Bernardo Herrera
Contact Person Email
ber.urologia@gmail.com
Site Name
Clinica Universidad De Navarra (second site)
Department Name
Urology
Contact Person Name
Felipe Villacampa
Contact Person Email
fvauba@unav.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Urology
Contact Person Name
Arturo Dominguez Garcia
Contact Person Email
adominguez@tauli.cat
Site Name
Hospital De Jerez De La Frontera
Department Name
Urology
Contact Person Name
Nelson Canales
Contact Person Email
nelsoncanalescasco@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Urology
Contact Person Name
Rafael Medina

Czechia

Earliest CTIS Part Ii Submission Date
21-05-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
713
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Urologická klinika 2. LF UK a FN
Contact Person Name
Antonín Brisuda
Contact Person Email
abrisuda@seznam.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Urologická klinika
Contact Person Name
Vladimír Košík
Contact Person Email
vladimir.kosik@vfn.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1. LF UK a FTN
Contact Person Name
Michaela Matoušková
Contact Person Email
matouskova@urocentrum.cz
Site Name
University Hospital Olomouc
Department Name
Urologická klinika
Contact Person Name
Milan Král
Contact Person Email
milan.kral@fnol.cz

Denmark

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
696
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Aarhus Universitetshospital
Department Name
Dept. of Urology /Urological Research Unit
Contact Person Name
Pernille Skjold Kingo
Contact Person Email
pernking@rm.dk
Site Name
Rigshospitalet
Department Name
Dept. of Urology
Contact Person Name
Andreas Roeder
Contact Person Email
andreas.roeder@region.dk
Site Name
Region Sjaelland
Department Name
Dept. of Urology
Contact Person Name
Juan Luis Vasquez
Contact Person Email
julv@regionsjaelland.dk
Site Name
Herlev Hospital
Department Name
Dept. of Urology
Contact Person Name
Gregers Gautier Hermann
Site Name
Odense University Hospital
Department Name
Urology Department
Contact Person Name
Lars Lund
Contact Person Email
Lars.Lund@rsyd.dk

Poland

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
701
Number Of Sites
9
Number Of Participants
24

Sites

Site Name
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Department Name
Oddzial Urologii
Contact Person Name
Grzegorz Sulimka
Contact Person Email
sulimka@lukasz.med.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Pododział Urologii
Contact Person Name
Krzysztof Tupikowski
Contact Person Email
krzysztof.tupikowski@dcopih.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Urologii i Urologii Onkologicznej
Contact Person Name
Jacek Kudelski
Contact Person Email
kl.urologii@uskwb.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddzial Urologiczny
Contact Person Name
Rafał Walczak
Contact Person Email
urologia@wszp.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Pododdzial Urologii
Contact Person Name
Tomasz Chwalinski
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Department Name
Klinika Urologii i Onkologii Urologicznej
Contact Person Name
Pawel Plaza
Contact Person Email
pawelplaza@umlub.pl
Site Name
In Vivo Sp. z o.o.
Department Name
Urologia
Contact Person Name
Marcin Zaremba
Contact Person Email
kontakt@in-vivo.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Kliniczny Oddzial Urologiczny
Contact Person Name
Paweł Hackemer
Contact Person Email
badaniakliniczne@4wsk.pl
Site Name
Wojewodzki Szpital (additional site)
Department Name
Urology
Contact Person Name
Rafał Walczak
Contact Person Email
urologia@wszp.pl

Belgium

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
708
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
Azorg
Department Name
Urology
Contact Person Name
Frederiek D'hondt
Contact Person Email
urologie.aalst@azorg.be
Site Name
Antwerp University Hospital
Department Name
Urology
Contact Person Name
Karen Fransis
Contact Person Email
urologie@uza.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Urology
Contact Person Name
Gilles Adans-Dester
Site Name
UZ Leuven
Department Name
Urology
Contact Person Name
Steven Joniau
Contact Person Email
steven.joniau@uzleuven.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Urology
Contact Person Name
Harm Arentsen
Contact Person Email
urologie@azsintjan.be
Site Name
Az Maria Middelares Gent
Department Name
Urology
Contact Person Name
Karel Decaestecker
Contact Person Email
Karel.Decaestecker@azmmsj.be
Site Name
Vitaz
Department Name
Urology
Contact Person Name
Bart De Troyer
Contact Person Email
bart.detroyer@vitaz.be

Italy

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
710
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOC Oncologia Medica
Contact Person Name
Rocco Papalia
Contact Person Email
rocco.papalia@unicampus.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Urologia
Contact Person Name
Paolo Gontero
Contact Person Email
paolo.gontero@unito.it
Site Name
Azienda USL Toscana Sud Est
Department Name
UO Oncologia Medica
Contact Person Name
Alketa Hamzaj
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
UO di Urologia
Contact Person Name
Angelo Porreca
Contact Person Email
angelo.porreca@gavazzeni.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Urologia
Contact Person Name
Nazareno Roberto Suardi
Contact Person Email
nazareno.suardi@unibs.it
Site Name
Humanitas Research Hospital
Department Name
Urologia e andrologia
Contact Person Name
Massimo Lazzeri
Contact Person Email
massimo.lazzeri@humanitas.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Urologia
Contact Person Name
Alberto Macchi
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Unità di Urologia
Contact Person Name
Giuseppe Simone
Contact Person Email
giuseppe.simone@ifo.it

Ireland

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
729
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Mater Private Hospital
Department Name
Medical Oncology
Contact Person Name
Waseem Darwish
Contact Person Email
waseem.darwish@materprivate.ie
Site Name
Cork University Hospital
Department Name
Medical Oncology
Contact Person Name
Richard Bambury
Contact Person Email
Richard.bambury@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Medical Oncology
Contact Person Name
Richard O’Dwyer
Contact Person Email
richardodwyer@mater.ie
Site Name
Tallaght University Hospital
Department Name
Urology
Contact Person Name
Louise Catherine Mcloughlin
Contact Person Email
louise.mcloughlin@tcd.ie

Austria

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
714
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Klinik fuer Urologie
Contact Person Name
Renate Pichler
Contact Person Email
renate.pichler@i-med.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung fuer Urologie
Contact Person Name
Ferdinand Luger
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Urologie und Andrologie
Contact Person Name
Maximilian Pallauf
Contact Person Email
m.pallauf@salk.at
Site Name
Medical University Of Vienna
Department Name
Universitatsklinik für Urologie
Contact Person Name
Shahrokh François Shariat
Site Name
Medical University Of Graz
Department Name
Universitaetsklinik fuer Urologie
Contact Person Name
Sascha Ahyai
Contact Person Email
sascha.ahyai@medunigraz.at

Germany

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
695
Number Of Sites
10
Number Of Participants
27

Sites

Site Name
Urologikum Hamburg MVZ
Department Name
Medizinzentrum Hammoniabad
Contact Person Name
Volker Heinemann
Contact Person Email
v.heinemann@web.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik fuer Urologie
Contact Person Name
Jens Bedke
Contact Person Email
j.bedke@klinikum-stuttgart.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik fuer Urologie
Contact Person Name
Marc Oliver Grimm
Site Name
Urologische Gemeinschaftspraxis
Department Name
Urologische Gemeinschaftspraxis
Contact Person Name
Alexander Rentschler
Contact Person Email
uroprax.st.joseph-dd@gmx.de
Site Name
Marien Hospital Herne -Universitaetsklinikum der Ruhr-Universitaet Bochum
Department Name
Klinik fuer Urologie
Contact Person Name
Karl Tully
Contact Person Email
karl.tully@elisabethgruppe.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
CCM - Klinik fuer Urologie
Contact Person Name
Maria de Santis
Contact Person Email
maria@desantis.cc
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Klinik für Urologie und Uroonkologie
Contact Person Name
Peter Hammerer
Contact Person Email
p.hammerer@skbs.de
Site Name
Urologische Partnerschaft Köln UPK
Department Name
Urologische Partnerschaft Köln UPK
Contact Person Name
Jens Klier
Contact Person Email
dr.klier@urologie-bayenthal.de
Site Name
Barmherzige Brueder gemeinnuetzige Traeger GmbH
Department Name
Abteilung für Urologie
Contact Person Name
Matthias May
Site Name
Goethe University Frankfurt
Department Name
Klinik fur Urologie
Contact Person Name
Clara Julia Humke
Contact Person Email
humke@med.uni-frankfurt.de

France

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
714
Number Of Sites
9
Number Of Participants
24

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Urology
Contact Person Name
Morgan Roupret
Contact Person Email
mroupret@gmail.com
Site Name
Capio La Croix Du Sud
Department Name
Urology
Contact Person Name
Benjamin Pradere
Contact Person Email
benjaminpradere@gmail.com
Site Name
Institut Gustave Roussy
Department Name
Department of Early Drug Development and Genitourinary Oncology Group
Principal Investigator Name
Yohann Loriot
Principal Investigator Email
Yohann.LORIOT@gustaveroussy.fr
Contact Person Name
Yohann Loriot
Contact Person Email
Yohann.LORIOT@gustaveroussy.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Urology, Andrology and Renal Transplantation
Contact Person Name
Matthieu Thoulouzan
Contact Person Email
thoulouzan.m@chu-toulouse.fr
Site Name
Polyclinique De Limoges
Department Name
Urology
Contact Person Name
Sabrina Falkowski
Contact Person Email
sf@imagemed-87.com
Site Name
Institut Paoli Calmettes
Department Name
Urology
Contact Person Name
Geraldine Pignot
Contact Person Email
pignotg@ipc.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris (Claude Vellefaux)
Department Name
Urology
Contact Person Name
Alexandra Masson-Lecomte
Contact Person Email
amassonlecomte@gmail.com
Site Name
Hospital Edouard Herriot
Department Name
Urology
Contact Person Name
Marc Colombel
Contact Person Email
marc.colombel@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris (Henri Huchard)
Department Name
Urology
Contact Person Name
Evanguelos Xylinas
Contact Person Email
evanguelos.xylinas@aphp.fr

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Almac Clinical Technologies LLC
Responsibilities
sponsor duties code:3 (listed in CTIS third parties)

Third parties

  • {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Convergent Genomics Inc.","duties_or_roles":"code:4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Qiagen Manchester Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-42756493
Active Substance
Erdafitinib
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Maximum Dose
0 mg (maxTotalDoseAmount reported as 0)
Investigational Product Name
MITOMYCIN
Active Substance
Mitomycin
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Maximum Dose
40 mg
Investigational Product Name
GEMCITABINE
Active Substance
Gemcitabine hydrochloride
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Maximum Dose
2000 mg

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