Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
45
Countries
1
Sites
7
Adult medulloblastoma
Key facts
- Sponsor
- CHRU De Nancy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Feb 2023 → ongoing
- Decision date (initial)
- 2024-05-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513243-85-00
- EudraCT number
- 2012-002803-16
- ClinicalTrials.gov
- NCT01857453
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult medulloblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027107 | Medulloblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHRU De Nancy
- Sponsor organisation
- CHRU De Nancy
- Address
- Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034
- City
- Nancy Cedex
- Postcode
- 54035
- Country
- France
Scientific contact point
- Organisation
- CHRU De Nancy
- Contact name
- Pr. Luc TAILLANDIER
Public contact point
- Organisation
- CHRU De Nancy
- Contact name
- M. El Mehdi SIAGHY, directeur de la Recherche et de l'Innovation
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 45 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Neuro-Oncologie, 80 Rue Brochier, 13005, Marseille
Centre Hospitalier Universitaire De Lille
Neurochirurgie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Assistance Publique Hopitaux De Paris
Neurologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire Amiens Picardie
Oncologie, 1 Place Victor Pauchet, 80080, Amiens
Centre Leon Berard
Radiothérapie, 28 Rue Laennec, 69008, Lyon
Institut Universitaire Du Cancer Toulouse-Oncopole
Radiothérapie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Regional Du Cancer De Montpellier
Radiothérapie, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
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 | 2013-04-10 | 2013-04-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-26741
- Halt date
- 2023-02-03
- Member states concerned
- France
- Publication date
- 2024-05-29
- Reason
- Sponsor decision
- Explanation
- arrêt temporaire des inclusions pour suspicion de manque d’efficacité
- Follow-up measures
- Mise en œuvre d’une mesure urgente de sécurité
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | France | Acceptable 2024-05-24
|
2024-05-24 |