Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
98
Countries
2
Sites
2
Nasopharyngeal Carcinoma
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
- 25 Nov 2024 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513281-19-00
- EudraCT number
- 2018-002580-26
- ClinicalTrials.gov
- NCT03891953
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Nasopharyngeal Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
| 20.0 | PT | 10061306 | Nasopharyngeal cancer | 100000004864 |
| 21.0 | PT | 10010035 | Colorectal cancer stage IV | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- 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
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 13 | 1 |
| Spain | Ongoing, recruitment ended | 19 | 1 |
| Rest of world
Taiwan, United States, Hong Kong, Japan
|
— | 66 | — |
Investigational sites
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
#3001:Medizinische Klinik I NCT / UCC-Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 | 2019-12-11 | 2019-12-11 | 2024-08-08 | ||
| Spain | 2021-06-17 | 2021-08-27 | 2024-08-08 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-41413
- Halt date
- 2024-08-08
- Member states concerned
- Germany
- Publication date
- 2024-08-19
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41411
- Halt date
- 2024-08-08
- Member states concerned
- Spain
- Publication date
- 2024-08-19
- 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 | 2024-07-09 | Germany | Acceptable 2024-08-08
|
2024-08-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-29 | Germany | Acceptable 2024-08-08
|
2024-11-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-27 | Germany | Acceptable 2025-06-04
|
2025-06-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-27 | Germany | Acceptable | 2026-04-27 |