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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 16, 2023

Primary Completion Date

December 30, 2025

Study Completion Date

June 30, 2026

Conditions
Myelodysplastic Syndromes
Interventions
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.

Trial Locations (1)

310003

The First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Otsuka Beijing Research Institute

INDUSTRY