Clinical Research Directory
Browse clinical research sites, groups, and studies.
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
Sponsor: Otsuka Beijing Research Institute
Summary
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Official title: An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2023-10-16
Completion Date
2027-06-30
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
IV Decitabine
The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.
Decitabine and cedazuridine
subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.
only Decitabine and cedazuridine
subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles, until disease progression, unacceptable toxicity, or the subject/investigator decides that the subject should discontinue treatment or withdraw from the trial.
Locations (1)
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China