Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
2
Countries
1
Sites
2
Advanced malignancies that harbor IDH1R132 mutations
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Jul 2015 → ongoing
- Decision date (initial)
- 2024-03-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507421-41-00
- EudraCT number
- 2014-004069-26
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced malignancies that harbor IDH1R132 mutations
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
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 2 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Jena KöR
3002: Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie, Erlanger Allee 101, Lobeda, Jena
Universitaetsklinikum Heidelberg AöR
3001: Abteilung Neuroonkologie, NCT und Neurologische Klinik, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
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 | 2015-07-20 | 2015-07-20 | 2017-06-29 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Germany | Acceptable 2024-03-11
|
2024-03-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-13 | Germany | Acceptable 2024-03-11
|
2025-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-04 | Germany | Acceptable 2025-08-28
|
2025-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-13 | Germany | Acceptable 2025-11-27
|
2025-11-27 |