ASTX727 vs IV Decitabine in MDS and CMML

Investigator: Jasleen Randhawa, MD

Study Coordinator: Michelle Guthrie

Status: Open Not Enrolling Number: NCT03306264

Phone: 713.441.6564

Protocol Number: Pro00020361


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.
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