Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
10
Countries
1
Sites
1
Hepatocellular carcinoma
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Nov 2022 → ongoing
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518298-33-00
- EudraCT number
- 2021-002910-15
- ClinicalTrials.gov
- NCT06218511
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hepatocellular carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10077746 | Hepatocellular carcinoma stage I | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Luigi Buonaguro
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Luigi Buonaguro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2022-11-21 | 2022-11-21 | 2025-08-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-21 | Italy | Acceptable 2024-11-06
|
2024-11-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-08 | Italy | Acceptable 2024-11-06
|
2025-04-08 |