Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
28
Countries
2
Sites
2
Glioma (diffuse astrocytoma, oligodendroglioma or glioblastoma)
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2023-07-17
- 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
Glioma (diffuse astrocytoma, oligodendroglioma or glioblastoma)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- S.E.M. Veldhuijzen van Zanten
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- J. de Jong
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 18 | 1 |
| Norway | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Radiology & Nuclear Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-20 | Netherlands | Acceptable 2023-07-13
|
2023-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-07 | Netherlands | Acceptable 2024-03-04
|
2024-03-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-17 | Netherlands | Acceptable | 2025-06-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-12 | Netherlands | Acceptable 2025-10-28
|
2025-10-28 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-11-25 | 2026-02-16 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-20 | Netherlands | Acceptable | 2026-05-13 |