Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
42
Countries
1
Sites
4
Glioblastoma
Key facts
- Sponsor
- Goethe University Frankfurt
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Nov 2017 → ongoing
- Decision date (initial)
- 2024-10-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511988-29-01
- EudraCT number
- 2016-000225-39
- ClinicalTrials.gov
- NCT03383978
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Goethe University Frankfurt
- Sponsor organisation
- Goethe University Frankfurt
- Address
- Theodor-Stern-Kai 7
- City
- Frankfurt Am Main
- Postcode
- 60590
- Country
- Germany
Scientific contact point
- Organisation
- Goethe University Frankfurt
- Contact name
- Dr. Senckenberg Institute of Neurooncology
Public contact point
- Organisation
- Goethe University Frankfurt
- Contact name
- Dr. Senckenberg Institute of Neurooncology
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 42 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Goethe University Frankfurt
Dr. Senckenberg Institute for Neurooncology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Heidelberg University
Neurochirurgische Klinik Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Heidelberg AöR
Department of Neurosurgery, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Neurochirurgische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
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 | 2017-11-08 | 2018-01-01 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Germany | Acceptable 2024-10-17
|
2024-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-19 | Germany | Acceptable | 2025-05-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-10 | Germany | 2025-06-10 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-27 | Germany | 2025-06-27 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-19 | Germany | 2026-01-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-27 | Germany | Acceptable 2026-04-20
|
2026-04-30 |