Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
33
Countries
1
Sites
8
Glioblastoma
Key facts
- Sponsor
- Grupo Espanol De Investigacion En Neurooncologia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Aug 2024 → 12 Nov 2025
- Decision date (initial)
- 2024-08-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515546-16-00
- EudraCT number
- 2016-003216-12
- ClinicalTrials.gov
- NCT03529448
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Grupo Espanol De Investigacion En Neurooncologia
- Sponsor organisation
- Grupo Espanol De Investigacion En Neurooncologia
- Address
- Calle De Velazquez 7 3a Planta
- City
- Madrid
- Postcode
- 28001
- Country
- Spain
Scientific contact point
- Organisation
- Grupo Espanol De Investigacion En Neurooncologia
- Contact name
- A person designed by the Sponsor
Public contact point
- Organisation
- Grupo Espanol De Investigacion En Neurooncologia
- Contact name
- A person designed by the Sponsor
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 33 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Regional De Malaga
Oncología Médica, Avenida De Carlos De Haya S/N, 29010, Malaga
Ajuntament De L Hospitalet De Llobregat
Oncología Médica, Calle D'amadeu Torner 63, 08902, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De Salamanca
Oncología Médica, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Virgen De Las Nieves
Oncología Médica, Avenida De Las Fuerzas Armadas 2, 18014, Granada
University Hospital Virgen Del Rocio S.L.
Oncología Médica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
University Hospital Son Espases
Oncología Médica, Carretera Valldemossa 79, 07120, Palma
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 |
|---|---|---|---|---|---|
| Spain | 2024-08-27 | 2025-11-12 | 2024-08-27 | 2024-08-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Spain | Acceptable with conditions 2024-08-27
|
2024-08-27 |