Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety,
pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk
category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In
phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new
subjects will be randomized in a 1:1 ratio into 2 doses/schedules.