A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 tablet to SC
azacitidine. The duration of the study is expected to be approximately 36 months.