Study #2020-0025
A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocy
MD Anderson Study Status
Enrolling
Treatment Agent
Azacitidine, ASTX030 (cedazuridine + azacitidine), Cedazuridine
Description
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 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Myelodysplastic Syndromes, Chronic Myelocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm
Study phase:
Phase II/III
Physician name:
Guillermo Garcia-Manero
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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