drugset / Trial / NCT02920541
Dose-escalation Study of Oral Administration of S 055746 in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety profile and tolerability of S 055746 in patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.
Timeline
- Start
- 2015-01
- Primary completion
- 2018-05-24
- Completion
- 2018-05-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S 55746 | Unknown | 50 mg | Oral |
| Subject | S 55746 | Unknown | 2000 mg | Oral |