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

NCT06091267 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-30

No results posted yet for this study

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

Interventions

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.

DRUG

IV Decitabine

The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2026-05-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091267 on ClinicalTrials.gov