Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
54
Countries
5
Sites
15
Glioblastoma
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 May 2024 → ongoing
- Decision date (initial)
- 2023-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502134-10-00
- ClinicalTrials.gov
- NCT05739942
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 4 | 3 |
| Germany | Ongoing, recruitment ended | 14 | 4 |
| Italy | Ended | 1 | 1 |
| Portugal | Ended | 2 | 1 |
| Spain | Ongoing, recruitment ended | 19 | 6 |
| Rest of world
United States, United Kingdom, Israel
|
— | 14 | — |
Investigational sites
Assistance Publique Hopitaux De Marseille
#1002:Nuclear medicine, 264 Rue Saint Pierre, 13005, Marseille
Centr Georges Francois Leclerc
#1000:Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Leon Berard
#1001:Medical Oncology, 28 Rue Laennec, 69008, Lyon
Universitaetsklinikum Essen AöR
#2000:Klinik fuer Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
#2003:Klinik und Poliklinik für Nuklearmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Rostock University Medical Center
#2001:Klinik und Poliklinik für Nuklearmedizin, Gertrudenplatz 1, Kroepeliner Tor Vorstadt, Rostock
Klinikum rechts der Isar der TU Muenchen AöR
#2002:Klinik und Poliklinik für Nuklearmedizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Azienda USL IRCCS Di Reggio Emilia
#8001:Struttura Complessa di Oncologia Provinciale Arcispedale Santa Maria Nuova, Viale Risorgimento 80, 42123, Reggio Emilia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
#9000:Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital General Universitario Gregorio Maranon
#6001:Oncología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Virgen De Las Nieves
#6005:Oncología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Institut Catala D'oncologia
#6000:Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
#6002:Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Germans Trias I Pujol
#6003:Oncología, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Del Mar
#6004:Oncología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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 | 2024-07-05 | 2024-07-05 | 2025-12-08 | ||
| Germany | 2024-09-05 | 2024-09-05 | 2025-08-14 | ||
| Italy | 2025-01-28 | 2025-01-28 | 2025-01-28 | ||
| Portugal | 2024-06-12 | 2024-06-12 | 2024-06-12 | ||
| Spain | 2024-05-15 | 2024-05-15 | 2026-01-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-77258
- Halt date
- 2025-03-17
- Member states concerned
- Portugal
- Publication date
- 2025-04-01
- Reason
- Medicinal Product related
- Explanation
- Gallium-68 Generator supply issue
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-08 | Spain | Acceptable with conditions 2023-11-24
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-19 | Spain | Acceptable 2024-02-27
|
2024-02-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Spain | Acceptable 2024-07-17
|
2024-07-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-31 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-02 | Spain | Acceptable 2025-05-23
|
2025-05-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-17 | Acceptable | 2026-01-21 |