Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
216
Countries
2
Sites
14
Localized Bladder Cancer
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Apr 2022 → ongoing
- Decision date (initial)
- 2024-03-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506265-65-00
- EudraCT number
- 2021-004144-22
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Localized Bladder Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 17 | 7 |
| Spain | Ongoing, recruitment ended | 26 | 7 |
| Rest of world
Korea, Republic of, Canada, United States, Japan, Israel
|
— | 173 | — |
Investigational sites
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Urologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Marien Hospital Herne Universitätsklinikum der Ruhr-Universität Bochum
Klinik fuer Urologie, Hoelkeskampring 40, 44625, Herne
Universitaetsklinikum Ulm AöR
Urologie- und Kinderurologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Muenster AöR
Klinik für Urologie und Kinderurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Frankfurt AöR
Klinik fuer Urologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Urologicum Duisburg
Urologicum Duisburg, Fahrner Straße 123, 47169, Duisburg
Urologie Neandertal - Praxis Mettmann
Urologie Neandertal, Praxis Mettmann, Adlerstrasse 1, Nordrhein-Westfalen, Mettmann
Hospital Universitario 12 De Octubre
Servicio de Urología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Urología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncology Deparmtent, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario La Paz
Servicio de Urología, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Servicio de Urología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Reina Sofia
Servicio de Urología, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinic De Barcelona
Servicio de Urología, Calle Villarroel 170, 08036, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-04-07 | 2022-04-07 | 2026-01-16 | ||
| Spain | 2022-04-08 | 2022-04-08 | 2026-01-16 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-14 | Spain | Acceptable 2024-03-18
|
2024-03-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-21 | Spain | Acceptable 2024-03-18
|
2024-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-26 | Spain | Acceptable 2024-06-27
|
2024-06-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-04 | Spain | Acceptable 2024-08-28
|
2024-08-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-20 | Spain | Acceptable 2025-05-23
|
2025-05-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-18 | Spain | Acceptable 2025-07-25
|
2025-07-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-05 | Spain | Acceptable 2026-02-22
|
2026-02-24 |