Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
220
Countries
4
Sites
7
Thymic 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
- 15 Mar 2024 → ongoing
- Decision date (initial)
- 2024-01-29
- 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
Thymic Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10027407 | Mesothelioma malignant | 100000004864 |
| 20.1 | PT | 10062878 | Gastrooesophageal cancer | 100000004864 |
| 21.0 | PT | 10073251 | Clear cell renal cell carcinoma | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | PT | 10061306 | Nasopharyngeal cancer | 100000004864 |
| 20.0 | PT | 10061424 | Anal cancer | 100000004864 |
| 21.1 | PT | 10055108 | Thymic cancer metastatic | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 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
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 30 | 2 |
| Germany | Ongoing, recruitment ended | 33 | 2 |
| Italy | Ongoing, recruitment ended | 22 | 2 |
| Spain | Ongoing, recruitment ended | 12 | 1 |
| Rest of world
Japan, Hong Kong, Singapore, Canada, United States, Taiwan, Korea, Republic of
|
— | 123 | — |
Investigational sites
Centre Leon Berard
#1001:Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
#1000:Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Essen AöR
#1500: Innere Klinik (Tumorforschunt), Hufelandstrasse 55, Holsterhausen, Essen
Technische Universitat Dresden
#1501: Medizinische Klinik und Poliklinik I, 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 |
|---|---|---|---|---|---|
| France | 2025-02-13 | 2026-03-05 | 2025-02-13 | 2025-12-09 | |
| Germany | 2024-03-22 | 2024-03-22 | 2026-01-02 | ||
| Italy | 2024-06-04 | 2024-06-04 | 2025-11-26 | ||
| Spain | 2024-03-15 | 2024-03-15 | 2025-11-14 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-22 | Germany | Acceptable 2024-01-25
|
2024-01-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-08 | Germany | Acceptable 2024-08-16
|
2024-08-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-18 | Germany | Acceptable 2024-12-13
|
2024-12-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-07 | Germany | Acceptable 2025-04-01
|
2025-04-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-14 | Germany | Acceptable 2026-03-12
|
2026-03-12 |