Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
15
Countries
1
Sites
8
Surgically treated high grade glioma after concomitant radiochemotherapy and adjuvant standard chemotherapy, with no or small stable tumor residue
Key facts
- Sponsor
- Universitaetsklinikum Muenster AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Oct 2022 → ongoing
- Decision date (initial)
- 2024-07-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513638-39-00
- EudraCT number
- 2015-004417-25
- ClinicalTrials.gov
- NCT05533242
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Surgically treated high grade glioma after concomitant radiochemotherapy and adjuvant standard chemotherapy, with no or small stable tumor residue
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Muenster AöR
- Sponsor organisation
- Universitaetsklinikum Muenster AöR
- Address
- Albert-Schweitzer-Campus 1, Sentrup Sentrup
- City
- Muenster
- Postcode
- 48149
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Muenster AöR
- Contact name
- Univ.-Prof. Dr. med. Walter Stummer
Public contact point
- Organisation
- Universitaetsklinikum Muenster AöR
- Contact name
- Univ.-Prof. Dr. med. Walter Stummer
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 15 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Klinik für Nuklearmedizin, Strahlenklinik, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Essen AöR
Klinik für Neurochirurgie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaet Muenster
Klinik für Nuklearmedizin, Albert-Schweitzer-Campus 1, Sentrup, Muenster
University Hospital Cologne AöR
Zentrum für Neurochirurgie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaet Muenster
Klinik für Neurochirurgie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
University Hospital Cologne AöR
Klinik für Nuklearmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Wuerzburg AöR
Neurochirurgischen Klinik und Poliklinik, Josef-Schneider-Strasse 11, Grombuehl, Wuerzburg
Universitaetsklinikum Wuerzburg AöR
Nuklearmedizinische Klinik und Poliklinik, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
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 | 2022-10-17 | 2024-01-22 | 2026-03-13 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-19 | Germany | Acceptable 2024-07-03
|
2024-07-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-11 | Germany | Acceptable 2024-11-04
|
2024-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-24 | Germany | Acceptable 2025-05-21
|
2025-05-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-08 | Germany | Acceptable 2025-05-21
|
2025-07-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-21 | Germany | Acceptable | 2026-01-06 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-25 | Germany | Acceptable | 2026-02-25 |