Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
91
Countries
1
Sites
13
Glioblastoma
Key facts
- Sponsor
- Centre Francois Baclesse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514144-85-02
- EudraCT number
- 2016-003468-38
- ClinicalTrials.gov
- NCT03212742
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
Centre Francois Baclesse
- Sponsor organisation
- Centre Francois Baclesse
- Address
- 3 Avenue Du General Harris, Cs 45026 Cs 45026
- City
- Caen Cedex 5
- Postcode
- 14076
- Country
- France
Scientific contact point
- Organisation
- Centre Francois Baclesse
- Contact name
- STEFAN Dinu
Public contact point
- Organisation
- Centre Francois Baclesse
- Contact name
- STEFAN Dinu
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 91 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Groupe Hospitalier Du Havre
Oncology department, 55 B Rue Gustave Flaubert, Bp 24, Le Havre Cedex
Oncopole Claudius Regaud
Radiotherapy department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie De L Ouest
Oncology department, 15 Rue Andre Boquel, 49100, Angers
CHU De Bordeaux
Service Oncologie Médicale, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Leon Berard
Radiotherapy, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
Service Oncologie-Radiothérapie, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Curie
Radiotherapy department, 26 Rue D Ulm, 75005, Paris
Groupe Hospitalier Bretagne Sud
Oncology, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Centre Henri Becquerel
Centre Onclogie Medicale, Rue D Amiens, 76038, Rouen Cedex
Centre De Radiotherapie Guillaume Le Conquerant
Radiotherapie, 61 Rue Denfert Rochereau, 76600, Le Havre
Hopitaux Universitaires Pitie Salpetriere
Service Oncologie-Radiothérapie, 47 To 83 Boulevard De L Hopital, 75013, Paris
CHU De Medecine Interne
Service Oncologie Médicale, 1 Place Victor Pauchet, Bp 20075, Amiens Cedex 2
Centre Francois Baclesse
Radiotherapie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | France | Acceptable 2024-11-08
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-18 | France | Acceptable 2026-04-10
|
2026-04-20 |