Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
18
Countries
1
Sites
1
Glioblastoma Multiforme
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 18 Jan 2024 → 19 Jul 2024
- Decision date (initial)
- 2023-10-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505743-38-00
- WHO UTN
- U1111-1294-4392
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma Multiforme
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
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
- P. Achaiber Sing
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- P. Achaiber Sing
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurosurgery, 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 | 2024-01-18 | 2024-07-19 | 2024-01-18 | 2024-07-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-21 | Netherlands | Acceptable 2023-10-16
|
2023-10-16 |