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A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)
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.
Study Objectives: Phase 1 Primary Objectives: To assess the safety profile of doses and schedules of ASTX727 LD. To select the ASTX727 LD dose(s) and schedule(s) to study in Phase 2. Secondary Objectives: To assess the pharmacodynamic (PD) activity of doses and schedules of ASTX727 LD. To characterize the pharmacokinetics (PK) of decitabine, cedazuridine, and its metabolite cedazuridine-epimer. To assess hematologic response. Phase 2 Primary Objective: To assess the clinical efficacy of the doses and schedules selected from Phase 1. Secondary Objectives: To assess the safety of the selected ASTX727 LD doses and schedules. To assess PD activity and PK of decitabine at the selected ASTX727 LD doses and schedules.