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Trial Summary


Protocol No.ASTX727-03
StatusOPEN TO ACCRUAL
Principal InvestigatorCripe, Larry
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA 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)
DescriptionMulticenter, 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. In Phase 1 Stage A, subjects will be randomized in a 1:1:1 ratio into 3 cohorts of 6 subjects each in a 10-day schedule in 28-day cycles; when safety is established in Stage A, 24 evaluable subjects will be randomized in a 1:1:1:1 ratio in Phase 1 Stage B into 4 cohorts of 6 subjects each in a 14-day schedule in 28-day cycles. In Phase 2, 40 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules selected from Phase 1.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Men or women greater than/equal to 18 years with IPSS low risk or Int-1 MDS.
  • Diagnosis of chronic myelomonocytic leukemia (CMML) is excluded.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLeukemia, other
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu