drugset / Trial / NCT02920541

Dose-escalation Study of Oral Administration of S 055746 in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

NCT02920541

Phase 1 Completed 48 enrolled Servier ADIR, a Servier Group company · collab
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

EvaluationDrugModalityDoseRoute
Subject S 55746 Unknown 50 mg Oral
Subject S 55746 Unknown 2000 mg Oral