Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
2
Sites
7
Non-muscle Invasive Bladder Cancer
Key facts
- Sponsor
- Urogen Pharma Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Oct 2022 → 9 Jan 2026
- Decision date (initial)
- 2024-07-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508404-37-00
- EudraCT number
- 2022-001278-73
- ClinicalTrials.gov
- NCT05375903
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 |
|---|---|---|---|---|
| 20.0 | PT | 10005005 | Bladder cancer recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Urogen Pharma Ltd.
- Sponsor organisation
- Urogen Pharma Ltd.
- Address
- 9 Ha-Ta'Asiya
- City
- Ra'Anana
- Postcode
- 4365405
- Country
- Israel
Scientific contact point
- Organisation
- Urogen Pharma Ltd.
- Contact name
- Caretha L. Creasy
Public contact point
- Organisation
- Urogen Pharma Ltd.
- Contact name
- Heather Lansford
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 28 | 3 |
| Spain | Ended | 20 | 4 |
| Rest of world
United States
|
— | 12 | — |
Investigational sites
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Italy | 2023-03-31 | 2025-10-14 | 2023-04-18 | 2025-01-07 | |
| Spain | 2022-10-26 | 2025-12-15 | 2023-02-14 | 2025-01-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Italy | Acceptable 2024-07-08
|
2024-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-25 | Italy | Acceptable 2024-07-08
|
2024-10-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-05 | Italy | Acceptable 2025-02-18
|
2025-02-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-26 | Italy | Acceptable 2025-02-18
|
2025-05-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-13 | Italy | Acceptable 2025-02-18
|
2025-08-13 |