Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
75
Countries
3
Sites
10
Non-muscle invasive bladder cancer
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Aug 2021 → 23 Sep 2025
- Decision date (initial)
- 2023-10-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503388-40-00
- EudraCT number
- 2021-001287-22
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-muscle invasive bladder cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10046715 | Urothelial carcinoma bladder recurrent | 10029104 |
| 20.0 | LLT | 10046714 | Urothelial carcinoma bladder | 10029104 |
| 21.0 | LLT | 10046718 | Urothelial carcinoma bladder stage I with cancer in situ | 10029104 |
| 21.0 | LLT | 10046716 | Urothelial carcinoma bladder stage 0 with cancer in situ | 10029104 |
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
| 20.0 | LLT | 10077056 | Urothelial carcinoma recurrent | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Seagen Inc.
- Sponsor organisation
- Seagen Inc.
- Address
- 21823 30th Drive Southeast
- City
- Bothell
- Postcode
- 98021-3907
- Country
- United States
Scientific contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 8 | 3 |
| Germany | Ended | 10 | 3 |
| Spain | Ended | 12 | 4 |
| Rest of world
United Kingdom, Canada, United States
|
— | 45 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Urology, 2 Rue Henri Le Guilloux, 35000, Rennes
Hospices Civils De Lyon
Urology, 5 Place D Arsonval, 69437, Lyon Cedex 03
Assistance Publique Hopitaux De Paris
Urology, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Universitaetsmedizin Goettingen
Urology, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Tuebingen AöR
Urology, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
ECTU, Robert-Koch-Strasse 40, Weende, Goettingen
Hospital Universitario 12 De Octubre
Urology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Urology, Calle Villarroel 170, 08036, Barcelona
Fundacio Puigvert
Urology, Calle De Cartagena 340-350, 08025, Barcelona
Hospital Universitari Vall D Hebron
Urology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| France | 2021-08-24 | 2025-07-14 | 2022-10-13 | 2023-06-13 | |
| Germany | 2023-03-01 | 2025-08-28 | 2024-04-18 | 2025-08-11 | |
| Spain | 2021-10-22 | 2025-09-22 | 2022-07-11 | 2024-07-17 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | Germany | Acceptable 2023-10-25
|
2023-10-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-22 | Acceptable 2023-10-25
|
2023-12-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Germany | Acceptable 2024-08-02
|
2024-08-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-24 | Germany | Acceptable 2025-03-31
|
2025-04-01 |