Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
236
Countries
1
Sites
3
AG-120 is being investigated for the treatment of patients with advanced hematologic malignancies that are IDH1 mutation.
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jul 2014 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511344-11-00
- EudraCT number
- 2014-000480-40
- ClinicalTrials.gov
- NCT02074839
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
AG-120 is being investigated for the treatment of patients with advanced hematologic malignancies that are IDH1 mutation.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10024291 | Leukaemias acute myeloid | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 72 | 3 |
| Rest of world
United States
|
— | 164 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Service d'hematologie, Avenue De Magellan, 33600, Pessac
Institut Gustave Roussy
Service SITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Service d'Hematologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
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 | 2014-07-18 | 2014-07-22 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | France | Acceptable 2024-08-09
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-14 | France | Acceptable 2025-02-07
|
2025-02-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-02 | France | Acceptable 2025-02-07
|
2025-05-02 |