Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
55
Countries
3
Sites
8
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
- 10 May 2022 → ongoing
- Decision date (initial)
- 2024-05-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506719-17-00
- EudraCT number
- 2021-003672-14
- ClinicalTrials.gov
- NCT05109728
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
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 9 | 2 |
| Portugal | Ended | 4 | 1 |
| Spain | Ended | 21 | 5 |
| Rest of world
United States, Switzerland
|
— | 21 | — |
Investigational sites
Assistance Publique Hopitaux De Marseille
#1001:Service Medecine Nucleaire, 264 Rue Saint Pierre, 13005, Marseille
Hospital Pierre Wertheimer
#1000:Service de neuro-oncologie, 59 Boulevard Pinel, 69500, Bron
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
#2000:Serviço Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Universitario 12 De Octubre
#3002:Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De Las Nieves
#3003:Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitari Vall D Hebron
#3000:Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
#3004:Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinic De Barcelona
#3001:Oncology, Calle Villarroel 170, 08036, 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 | 2022-05-27 | 2022-05-27 | 2025-04-11 | ||
| Portugal | 2022-05-31 | 2025-08-20 | 2022-05-31 | 2024-05-23 | |
| Spain | 2022-05-10 | 2025-10-21 | 2022-05-10 | 2024-07-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-77307
- 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
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | Spain | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Spain | Acceptable 2025-01-10
|
2025-01-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-04 | Spain | Acceptable 2025-01-10
|
2025-02-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-04 | Spain | Acceptable with conditions 2025-08-26
|
2025-08-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-29 | Spain | Acceptable 2025-12-15
|
2025-12-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-13 | Spain | Acceptable 2026-03-30
|
2026-03-30 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-26 | Spain | Acceptable 2026-03-30
|
2026-05-26 |