Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML
Status:
Recruiting
Trial end date:
2022-05-31
Target enrollment:
Participant gender:
Summary
Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine.
Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive
the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2,
or the converse order. After completion of PK studies during the first 2 treatment cycles,
subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day
cycles) until disease progression, unacceptable toxicity, or the subject discontinues
treatment or withdraws from the study.