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Trial Summary
| Protocol No. | ASTX727-03 | ||
|---|---|---|---|
| Status | OPEN TO ACCRUAL | ||
| Principal Investigator | Cripe, Larry | ||
| Scope | National | ||
| Phase | Phase I/II | ||
| Age Group | Adult | ||
| Title | 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) | ||
| Description | 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. 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 Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria:
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| Applicable Disease Sites | Leukemia, other | ||
| Participating Institutions | Indiana University (IU) | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||