NCT06091267

PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes

An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	IV Decitabine	The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.
DRUG	Decitabine and cedazuridine	subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.
DRUG	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.

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-05-31
• Completion: 2027-06-30
• First posted: 2023-10-19
• Last updated: 2026-01-30

Locations

1 site across 1 country: China