Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
24
Adults with non-contrast-enhancing diffuse brainstem gliomas with non-threatening infiltrative clinical and/or radiological progression
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 19 Jul 2019 → ongoing
- Decision date (initial)
- 2024-08-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511862-35-00
- EudraCT number
- 2018-002654-79
- ClinicalTrials.gov
- NCT03932981
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adults with non-contrast-enhancing diffuse brainstem gliomas with non-threatening infiltrative clinical and/or radiological progression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10065443 | Malignant glioma | 100000004864 |
| 20.0 | PT | 10006143 | Brain stem glioma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Florence LAIGLE-DONADEY
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Florence LAIGLE-DONADEY
Locations
1 EU/EEA country · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 24 |
| Rest of world | — | 0 | — |
Investigational sites
Institut de Cancérologie de l'Ouest - site d'Angers
Oncologie Médicale, 15 rue André Boquel, 49055, ANGERS
CHU Amiens - Groupe Hospitalier Sud
Oncologie Médicale et Neurologie, 1 1 rond-point du Professeur Cabrol, 80054, AMIENS
Centre Hospitalier Et Universitaire De Limoges
Oncologie Médicale, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
CHRU de Brest - Hôpital de la cavale Blanche
Neurochirurgie, Boulevard Tanguy Prigent, 29200, Brest
Hospital Foch
Neuroscience, 40 Rue Worth, 92150, Suresnes
Hôpitaux Universitaires de Marseille Timone
Neuro-oncologie, 264 Rue Saint-Pierre, 13385, Marseille
Institut Regional Du Cancer De Montpellier
Oncologie Médicale, 208 Avenue Des Apothicaires, 34090, Montpellier
Assistance Publique Hopitaux De Paris
NEUROLOGIE, 43 Boulevard De L Hopital, 75013, Paris
CHU Rennes - Hôpital Pontchaillou- Centre Eugène Marquis
Oncologie Médicale, Av. de la Bataille Flandres-Dunkerque CS 44229, 35000, Rennes
Centre Hospitalier Universitaire Rouen
Neurochirurgie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Lille
Neuro-onclologie, Rue Emile Laine, 59037, Lille Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Oncologie Médicale, 2 Avenue Marechal Foch, 29200, Brest
CHU Grenoble Alpes - Hôpital Michallon
Oncologie médicale, Boulevard de la Chantourne, 38700, La Tronche
Institut Gustave Roussy
Onco-radiologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre de Coordination en Cancérologie François Baclesse
Neur-onclologie, 3 Avenue Général Harris, 14076, CAEN
CHU de Nice- Hôpital Pasteur 2
NEUROLOGIE, 30, Voie Romaine CS 51069, Nice
CHU Saint Etienne Hôpital Nord
NEUROLOGIE, Av. Albert Raimond, 42055, Saint Etienne
Centre De Recherche En Cancerologie De Lyon
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Henri Becquerel
Oncologie Médicale, Rue D Amiens, 76038, Rouen Cedex
Hospices Civils de LYON - Hôpital Pierre Wertheimer
Neuro-oncologie, 59 Boulevard Pinel, 69500, Bron
CHRU De Nancy
Neuro-oncologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier De Colmar
NEUROLOGIE, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
CHU Saint Eloi
Neurochirurgie, 8 0Avnenue Augustin Fliche, 34295, Montpellier
ICANS - Institut de cancérologie Strasbourg Europe
RADIOTHÉRAPIE | RADIOISOTOPES | RADIOLOGIE | RADIOPHYSIQUE, 17 Rue Albert Calmette, 67200, Strasbourg
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 | 2019-07-19 | 2019-07-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | France | Acceptable 2024-06-24
|
2024-08-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-08 | France | Acceptable 2024-06-24
|
2025-10-08 |