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 Myelomon

Brief description of study

This study is testing a new drug called oral ASTX030 in people who have myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). The study is divided into three phases. In Phase 1, the drug will be given to a small group of people (individuals with only MDS or CMML specifically) to see how much of oral ASTX030 they can take before experiencing side effects. In Phase 2, oral ASTX030 will be compared to an already-approved treatment (subcutaneous azacitidine) to see how well it works. In Phase 3, oral ASTX030 will be tested on a larger group of people to see how effective it is compared to the already-approved treatment. The goal of the study is to find the best doseage of the new drug that helps with MDS, CMML and AML. The study will also look at how safe oral ASTX030 is and how well it is accepted by the participants.




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