Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
176
Countries
3
Sites
12
Glioblastoma
Key facts
- Sponsor
- Philogen S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Jul 2023 → ongoing
- Decision date (initial)
- 2023-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501822-39-00
- ClinicalTrials.gov
- NCT03779230
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Philogen S.p.A.
- Sponsor organisation
- Philogen S.p.A.
- Address
- Piazza La Lizza 7
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Teresa Hemmerle
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Teresa Hemmerle
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 28 | 3 |
| Germany | Ongoing, recruiting | 40 | 4 |
| Italy | Ongoing, recruiting | 45 | 5 |
| Rest of world
Switzerland
|
— | 63 | — |
Investigational sites
Hopital Universitaire Pitie Salpetriere
Neurologie 2/ Neuro-oncologie, 47 To 83 Boulevard De L Hopital, 75651, Paris Cedex 13
Hospital Pierre Wertheimer
Neuro Oncology, 59 Boulevard Pinel, 69500, Bron
Hopital Saint Louis
Neurology, 1 Avenue Claude Vellefaux, 75010, Paris
Universitaetsklinikum Bonn AöR
Neurology, Venusberg-Campus 1, Venusberg, Bonn
Klinikum rechts der Isar der TU Muenchen AöR
Neurology, Ismaninger Straße 22, Au-Haidhausen, Munich
Universitaetsklinikum Tuebingen
Neurology and Interdisciplinary Neuro-Oncology, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
University Hospital Cologne AöR
Neurology, Kerpener Strasse 62, Lindenthal, Cologne
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Neuro Oncologia Clinica, Corso Bramante 88, 10126, Turin
Instituto Di Ricovero E Cura A Catattere Scientifico
UOC Oncologia del sistema nervoso, Ospedale Bellaria, Via Altura 3, Bologna
Veneto Institute Of Oncology
Oncologia 1, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Senese
UOC Immunoterapia Oncologica, Viale Mario Bracci 2, 53100, Siena
The Foundation Of The Carlo Besta Neurological Institute IRCCS
Neurologia II - Neuro Oncology, Via Giovanni Celoria 11, 20133, Milan
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 | 2024-07-25 | 2024-09-16 | |||
| Germany | 2023-07-31 | 2023-08-07 | |||
| Italy | 2023-09-21 | 2023-10-02 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-10 | Germany | Acceptable with conditions 2023-02-13
|
2023-02-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-31 | Germany | Acceptable 2023-05-30
|
2023-05-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-03 | Germany | Acceptable 2023-12-04
|
2023-12-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-01 | Germany | Not acceptable 2024-10-07
|
2024-10-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-13 | Germany | Acceptable 2025-03-03
|
2025-03-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-17 | Germany | Acceptable 2025-12-19
|
2025-12-19 |