Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
116
Countries
3
Sites
7
Recurrent glioblastoma multiforme (GBM)
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
- 29 Nov 2024 → 14 Dec 2024
- Decision date (initial)
- 2023-08-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Recurrent glioblastoma multiforme (GBM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10055102 | Oesophageal cancer metastatic | 100000004864 |
| 21.0 | PT | 10033610 | Pancreatic carcinoma metastatic | 100000004864 |
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 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 · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 14 | 2 |
| Netherlands | Ended | 8 | 1 |
| Spain | Ended | 33 | 4 |
| Rest of world
Israel, Switzerland, United States
|
— | 61 | — |
Investigational sites
Fondazione IRCCS Istituto Nazionale Dei Tumori
1001:Dipartimento di Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Azienda USL IRCCS Di Reggio Emilia
1000:S.C. Medicina Nucleare, Viale Risorgimento 80, 42123, Reggio Emilia
Stichting Radboud University Medical Center
2000:Beeldvorming, sectie Nuclaire Geneeskunde, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Universitario 12 De Octubre
3002:Servicio de Oncologia, Bloque D, Avenida De Cordoba S/n, Madrid
Institut Catala D'oncologia
3003:Servicio de Oncologia, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
3000:Servicio de Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Ramon Y Cajal
3001:Servicio de Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-12-18 | 2023-12-18 | 2024-10-11 | ||
| Spain | 2024-01-04 | 2024-01-04 | 2024-10-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-53778
- Halt date
- 2024-10-11
- Member states concerned
- Spain
- Publication date
- 2024-10-24
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-53776
- Halt date
- 2024-10-11
- Member states concerned
- Netherlands
- Publication date
- 2024-10-24
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | Spain | Acceptable 2023-07-28
|
2023-07-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-08 | Acceptable | 2023-09-01 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-11 | Spain | Acceptable | 2023-10-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-09 | Spain | Acceptable | 2024-12-09 |