Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
10
Countries
1
Sites
1
Glioblastoma
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Apr 2024 → ongoing
- Decision date (initial)
- 2023-10-27
- 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
Glioblastoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Nick Van Laeken
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Valerie Demeulenaere
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-04-10 | 2024-11-19 | 2026-01-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-116000
- Halt date
- 2026-01-21
- Planned restart
- 2026-09-01
- Member states concerned
- Belgium
- Publication date
- 2026-01-22
- Reason
- Investigator/Site related
- Explanation
- Long-term and planned absence of the sub-investigator.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-14 | Belgium | Acceptable with conditions 2023-10-26
|
2023-10-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-18 | Belgium | Acceptable 2024-02-19
|
2024-03-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-12 | Belgium | Acceptable 2024-02-19
|
2024-03-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-14 | Belgium | Acceptable 2024-02-19
|
2024-11-14 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-12-05 | Belgium | Acceptable 2024-02-19
|
2024-12-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-11 | Belgium | Acceptable 2025-04-11
|
2025-04-11 |