A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
The purpose of this study is to examine blood levels of the study drug during treatment and to see how subjects respond to the study drug.
This study is being done to answer the following question:
How would the body respond to ASTX727 (an oral formulation of Cedazuridine and Decitabine) versus the usual decitabine? Would ASTX727 help improve a patient’s body exposure to decitabine?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML).
Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with MDS or CMML
-Your disease has not responded to previous treatment or it has not been previously treated.
18 - n/a
Healthy Volunteers Needed
Duration of Participation
The study is estimated to last about 18 months.
Clinical Trials Information Line
Astex Pharmaceuticals, Inc.