Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
15
Countries
1
Sites
7
glioma WHO grade IV (C71.1-9 according to ICD-10 classification)
Key facts
- Sponsor
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Feb 2023 → ongoing
- Decision date (initial)
- 2024-08-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514840-97-00
- EudraCT number
- 2018-002874-40
- ClinicalTrials.gov
- NCT04808245
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
glioma WHO grade IV (C71.1-9 according to ICD-10 classification)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Sponsor organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Address
- Im Neuenheimer Feld 280, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Contact name
- Prof. Dr. med. Michael Platten
Public contact point
- Organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Contact name
- Prof. Dr. med. Michael Platten
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 15 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Klinische Neuroonkologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Bonn AöR
Sektion Klinische Neuroonkologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Neurochirurgie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Goethe University Frankfurt
Dr. Senckenbergisches Institut für Neuroonkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Mannheim GmbH
Neurologische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Heidelberg AöR
Neurologische Klinik, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen AöR
Neurologie mit Interdisziplinärem Schwerpunkt Neuroonkologie, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
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 |
|---|---|---|---|---|---|
| Germany | 2023-02-15 | 2023-02-15 | 2025-08-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | Germany | Acceptable with conditions 2024-07-17
|
2024-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-18 | Germany | Acceptable 2025-07-21
|
2025-07-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-17 | Germany | Acceptable 2025-07-21
|
2025-11-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-03 | Germany | Acceptable 2025-07-21
|
2025-12-03 |