Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Locally advanced or metastatic melanoma
Key facts
- Sponsor
- Herlev Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Aug 2024 → ongoing
- Decision date (initial)
- 2024-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced or metastatic melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025670 | Malignant melanoma stage III | 100000004864 |
| 21.1 | PT | 10025671 | Malignant melanoma stage IV | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herlev Hospital
- Sponsor organisation
- Herlev Hospital
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Herlev Hospital
- Contact name
- Cecilie Dam Vestergaard
Public contact point
- Organisation
- Herlev Hospital
- Contact name
- Cecilie Dam Vestergaard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 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 |
|---|---|---|---|---|---|
| Denmark | 2024-08-15 | 2024-08-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-29 | Denmark | Acceptable with conditions 2024-03-18
|
2024-03-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-19 | Denmark | Acceptable with conditions | 2024-05-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Denmark | Acceptable 2024-06-24
|
2024-06-25 |