Study #2018-0919
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 Syndomes (MDS)
MD Anderson Study Status
Not Accepting
Treatment Agent
ASTX727 LD, ASTX727 SD
Description
Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Myelodysplastic Syndromes
Study phase:
Physician name:
Guillermo Garcia-Manero
Department:
Leukemia
For general questions about clinical trials:
1-866-230-7585
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