Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
35
Countries
1
Sites
4
Menangiomas
Key facts
- Sponsor
- Centre Hospitalier Regional De Marseille
- 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
- 30 Sep 2019 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515836-61-00
- EudraCT number
- 2018-004282-13
- ClinicalTrials.gov
- NCT03631953
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Menangiomas
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional De Marseille
- Sponsor organisation
- Centre Hospitalier Regional De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Thomas Graillon
Public contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Sophie Tardoski
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 35 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Neurochirurgie, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Neurologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Bordeaux
Oncologie médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Pellegrin Hospital
Neurochirurgie, Place Amelie Raba Leon, 33000, Bordeaux
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 | 2019-09-30 | 2019-09-30 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-13 | France | Acceptable 2024-08-09
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-17 | France | Acceptable 2025-02-07
|
2025-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-12 | France | Acceptable 2026-02-19
|
2026-02-19 |