Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
76
Countries
2
Sites
10
Acute Myeloid Leukemias
Key facts
- Sponsor
- Syndax Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 May 2025 → ongoing
- Decision date (initial)
- 2025-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514531-18-00
- ClinicalTrials.gov
- NCT06226571
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemias
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10024330 | Leukemia acute | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Syndax Pharmaceuticals Inc.
- Sponsor organisation
- Syndax Pharmaceuticals Inc.
- Address
- 730 3rd Avenue Floor 9
- City
- New York
- Postcode
- 10017-3206
- Country
- United States
Scientific contact point
- Organisation
- Syndax Pharmaceuticals Inc.
- Contact name
- Jessica Clement
Public contact point
- Organisation
- Syndax Pharmaceuticals Inc.
- Contact name
- Clinical Trials
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 4 | 1 |
| Spain | Ongoing, recruiting | 18 | 9 |
| Rest of world
United States, Australia, United Kingdom, Canada
|
— | 54 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinic De Barcelona
Hematolgy, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Hematology, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
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 | 2025-07-02 | 2025-08-07 | |||
| Spain | 2025-05-20 | 2025-05-22 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Spain | Acceptable with conditions 2025-02-03
|
2025-02-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-10 | Spain | Acceptable 2025-04-28
|
2025-05-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-30 | Spain | Acceptable 2025-04-28
|
2025-05-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-21 | Spain | Acceptable 2026-04-24
|
2026-04-28 |