Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
25
Countries
1
Sites
1
Metastatic colorectal cancer
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Dec 2024 → ongoing
- Decision date (initial)
- 2024-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
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
- M. van den Bos
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- M. van den Bos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Nuclear Medicine, Plesmanlaan 121, 1066 CX, Amsterdam
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 | 2024-12-12 | 2025-01-13 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-23 | Netherlands | Acceptable with conditions 2024-08-12
|
2024-08-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-22 | Netherlands | Acceptable with conditions 2024-08-12
|
2025-12-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-24 | Netherlands | Acceptable with conditions 2024-08-12
|
2025-12-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-18 | Netherlands | Acceptable with conditions 2024-08-12
|
2026-02-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-03 | Netherlands | Acceptable with conditions 2024-08-12
|
2026-03-03 |