Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
2
MGMT-Methylated, IDH wild-type glioblastoma
Key facts
- Sponsor
- Istituto Oncologico Veneto
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 4 Jul 2022 → 22 Dec 2025
- Decision date (initial)
- 2025-01-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514424-16-00
- EudraCT number
- 2021-001604-15
- ClinicalTrials.gov
- NCT06095375
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
MGMT-Methylated, IDH wild-type glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Istituto Oncologico Veneto
- Sponsor organisation
- Istituto Oncologico Veneto
- Address
- Via Gattamelata 64
- City
- Padova
- Postcode
- 35128
- Country
- Italy
Scientific contact point
- Organisation
- Istituto Oncologico Veneto
- Contact name
- Gian Luca De Salvo
Public contact point
- Organisation
- Istituto Oncologico Veneto
- Contact name
- Gian Luca De Salvo
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 36 | 2 |
| 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 |
|---|---|---|---|---|---|
| Italy | 2022-07-04 | 2025-12-22 | 2022-07-04 | 2024-08-21 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-10 | Italy | Acceptable 2025-01-22
|
2025-01-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-05 | Italy | Acceptable 2025-01-22
|
2025-12-05 |