Clinical trial • Phase I/II • Oncology

erdafitinib for Non-muscle-invasive bladder cancer | Muscle-invasive bladder cancer

Phase I/II trial of erdafitinib for Non-muscle-invasive bladder cancer | Muscle-invasive bladder cancer. 173 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-muscle-invasive bladder cancer | Muscle-invasive bladder cancer
Trial Stage
Phase I/II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-12-2023
First CTIS Authorization Date
18-03-2024

Trial design

Phase I/II trial across 16 sites in Spain, Germany.

Target Sample Size
173

Eligibility

Recruits 173 isVulnerablePopulationSelected: true. No further details on vulnerable population definitions, consent or assent handling are provided in the available documents..

Vulnerable Population
isVulnerablePopulationSelected: true. No further details on vulnerable population definitions, consent or assent handling are provided in the available documents.

Recruitment

Planned Sample Size
173
Recruitment Window Months
82

Geography

Total Number Of Sites
16
Total Number Of Participants
173

Spain

Earliest CTIS Part Ii Submission Date
16-01-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
776
Number Of Sites
7
Number Of Participants
26

Sites

Site Name
Hospital Universitario La Paz
Department Name
Servicio de Urología
Principal Investigator Name
Mario Alvarez-Maestro
Principal Investigator Email
malvarezmaestro@hotmail.com
Contact Person Name
Mario Alvarez-Maestro
Contact Person Email
malvarezmaestro@hotmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Urología
Principal Investigator Name
Antoni Vilaseca Cabo
Principal Investigator Email
avilasec@clinic.cat
Contact Person Name
Antoni Vilaseca Cabo
Contact Person Email
avilasec@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Urología
Principal Investigator Name
Félix Guerrero Ramos
Principal Investigator Email
felixguerrero@gmail.com
Contact Person Name
Félix Guerrero Ramos
Contact Person Email
felixguerrero@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Urología
Principal Investigator Name
Jose Horacio Garcia Rubio
Principal Investigator Email
josehgr@gmail.com
Contact Person Name
Jose Horacio Garcia Rubio
Contact Person Email
josehgr@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology Deparmtent
Principal Investigator Name
Jose Luis Dominguez-Escrig
Principal Investigator Email
jldominguezescrig@hotmail.com
Contact Person Name
Jose Luis Dominguez-Escrig
Contact Person Email
jldominguezescrig@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Urología
Principal Investigator Name
Carles Raventós Busquets
Principal Investigator Email
carlesxavier.raventos@vallhebron.cat
Contact Person Name
Carles Raventós Busquets
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Urología
Principal Investigator Name
Elena Buendía González
Principal Investigator Email
elena.buendia@quironsalud.es
Contact Person Name
Elena Buendía González
Contact Person Email
elena.buendia@quironsalud.es

Germany

Earliest CTIS Part Ii Submission Date
16-01-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
770
Number Of Sites
9
Number Of Participants
17

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Christian Thomas
Principal Investigator Email
Christian.Thomas@ukdd.de
Contact Person Name
Christian Thomas
Contact Person Email
Christian.Thomas@ukdd.de
Site Name
Marien Hospital Herne Universitätsklinikum der Ruhr-Universität Bochum
Department Name
Klinik fuer Urologie
Principal Investigator Name
Florian Roghmann
Principal Investigator Email
florian.roghmann@elisabethgruppe.de
Contact Person Name
Florian Roghmann
Site Name
Urologie Neandertal - Praxis Mettmann
Department Name
Urologie Neandertal, Praxis Mettmann
Principal Investigator Name
Philip Spiegelhalder
Principal Investigator Email
p_spiegelhalder@web.de
Contact Person Name
Philip Spiegelhalder
Contact Person Email
p_spiegelhalder@web.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Urologie- und Kinderurologie
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
Friedemann.Zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Urologie und Kinderurologie
Principal Investigator Name
Martin Boegemann
Principal Investigator Email
martin.boegemann@ukmuenster.de
Contact Person Name
Martin Boegemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Urologicum Duisburg
Department Name
Urologicum Duisburg
Principal Investigator Name
Eva Hellmis
Principal Investigator Email
hellmis@urologicum-duisburg.de
Contact Person Name
Eva Hellmis
Contact Person Email
hellmis@urologicum-duisburg.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik fuer Urologie
Principal Investigator Name
Clara Humke
Principal Investigator Email
clara.humke@unimedizin-ffm.de
Contact Person Name
Clara Humke
Contact Person Email
clara.humke@unimedizin-ffm.de
Site Name
Universitaetsklinikum (additional site entry)
Site Name
Universitaetsklinikum (additional site entry)

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
Erdafitinib Intravesical Delivery System (TAR-210)
Active Substance
erdafitinib
Modality
Small molecule
Routes Of Administration
Intravesical
Route
Intravesical

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