Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
56
Countries
1
Sites
5
gliobastoma
Key facts
- Sponsor
- Centre Antoine Lacassagne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Jun 2015 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510960-22-00
- EudraCT number
- 2014-001578-32
- ClinicalTrials.gov
- NCT02331498
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
gliobastoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Antoine Lacassagne
- Sponsor organisation
- Centre Antoine Lacassagne
- Address
- 33 Avenue De Valombrose
- City
- Nice Cedex 2
- Postcode
- 06189
- Country
- France
Scientific contact point
- Organisation
- Centre Antoine Lacassagne
- Contact name
- Dr Esma SAADA-BOUZID
Public contact point
- Organisation
- Centre Antoine Lacassagne
- Contact name
- Dr Esma SAADA-BOUZID
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 56 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Marseille
neuro-oncology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nice
Neurology, 30 Voie Romaine, 06000, Nice
Institut De Cancerologie De L Ouest
Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut De Cancerologie De L Ouest
Medical oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
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 |
|---|---|---|---|---|---|
| France | 2015-06-25 | 2015-06-25 | 2026-04-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | France | Acceptable 2024-04-15
|
2024-04-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-11 | France | Acceptable 2024-09-23
|
2024-09-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-09 | France | Acceptable 2025-10-07
|
2025-10-20 |