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) [ASTX727-02]
This Phase 3 study will establish PK equivalence of ASTX727 to IV decitabine in approximately
118 evaluable subjects. Eligible subjects will receive both study treatments: oral
investigational drug ASTX727, and IV decitabine, as follows: subjects will be randomly
assigned 1:1 to receive ASTX727 or IV decitabine in Cycle 1 and then cross over to the other
therapy in Cycle 2.
In the ASTX727 cycle, subjects will receive the ASTX727 tablet Daily×5. Serial PK
measurements (blood draws) will be done on Days 1, 2, and 5, along with pre-dose PK
assessments on Days 1-5 and an assessment at 3 hours post dose on Day 3. Subjects will be
required to fast from food for 4 hours on days when receiving ASTX727: at least 2 hours
before and 2 hours after dosing.
In the IV decitabine cycle, subjects will receive a 1-hour infusion of IV decitabine 20
mg/m^2 Daily×5. Serial PK measurements will be done on Days 1 and 5, along with pre-dose and
1-hour post-infusion assessments on Day 3.
In Cycles ≥3, subjects will receive the ASTX727 tablet Daily×5 in 28-day cycles. (No PK
assessments will be done from Cycle 3 onward.)