Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
14
Countries
1
Sites
2
Cancer
Key facts
- Sponsor
- Hospital De Sant Pau I Santa Tecla
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519602-12-01
- EudraCT number
- 2020-005292-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital De Sant Pau I Santa Tecla
- Sponsor organisation
- Hospital De Sant Pau I Santa Tecla
- Address
- Rambla Vella 14
- City
- Tarragona
- Postcode
- 43003
- Country
- Spain
Scientific contact point
- Organisation
- Hospital De Sant Pau I Santa Tecla
- Contact name
- Vicente Valentí
Public contact point
- Organisation
- Hospital De Sant Pau I Santa Tecla
- Contact name
- Vicente Valentí
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 14 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-20 | Spain | Acceptable with conditions 2025-01-30
|
2025-01-30 |