Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
12
Countries
2
Sites
2
Glioblastoma multiforme (GBM)
Key facts
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Jun 2023 → ongoing
- Decision date (initial)
- 2024-09-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515466-13-00
- EudraCT number
- 2022-003038-38
- ClinicalTrials.gov
- NCT05450744
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma multiforme (GBM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor organisation
- Telix Pharmaceuticals (Innovations) Pty Limited
- Address
- 55 Flemington Road
- City
- North Melbourne
- Postcode
- 3051
- Country
- Australia
Scientific contact point
- Organisation
- Telix Pharmaceuticals (Innovations) Pty Limited
- Contact name
- Global Clinical Operations
Public contact point
- Organisation
- Telix Pharmaceuticals (Innovations) Pty Limited
- Contact name
- Corporate Communications
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 3 | 1 |
| Netherlands | Ongoing, recruitment ended | 3 | 1 |
| Rest of world
New Zealand, Australia
|
— | 6 | — |
Investigational sites
Johannes Kepler University Linz
Neuroonkologisches Zentrum, Wagner Jauregg Weg 15, 4020, Linz
Universitair Medisch Centrum Utrecht
Radiology, 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 |
|---|---|---|---|---|---|
| Austria | 2023-06-29 | 2023-08-02 | 2026-04-01 | ||
| Netherlands | 2023-06-28 | 2026-01-16 | 2026-04-01 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Austria | Acceptable 2024-09-06
|
2024-09-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-06 | Austria | Acceptable 2025-02-24
|
2025-03-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-28 | Acceptable 2025-02-24
|
2025-03-28 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-16 | Austria | Acceptable 2025-02-24
|
2025-06-16 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-25 | Austria | Acceptable 2025-02-24
|
2025-06-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-02 | Austria | Acceptable 2025-02-24
|
2025-07-02 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-23 | Austria | Acceptable | 2025-09-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-07 | Acceptable | 2025-09-25 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-01-21 | Austria | Acceptable | 2026-01-21 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-01-21 | Austria | Acceptable | 2026-01-21 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-06-24 | Austria | Acceptable | 2026-06-24 |