Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
1
colorectal liver metastases
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Oct 2019 → 27 Jan 2025
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514767-26-00
- EudraCT number
- 2018-002940-97
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
colorectal liver metastases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Prof. dr. M.G.E.H. Lam
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Prof. dr. M.G.E.H. Lam
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Nuclear Medicine, Division Imaging & Oncology, Heidelberglaan 100, 3584 CX, Utrecht
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 |
|---|---|---|---|---|---|
| Netherlands | 2019-10-11 | 2025-01-27 | 2019-10-11 | 2025-01-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Netherlands | Acceptable with conditions 2024-08-22
|
2024-08-22 |