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

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Treatments: Decitabine; Decitabine and cedazuridine drug combination

Criteria

Inclusion Criteria:

1. Agree to participate in this trial and voluntarily sign the informed consent form.

2. Men or women ≥ 18 years at the time of signing the informed consent form.

3. Subjects with MDS previously treated or untreated with de novo or secondary MDS.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.

Exclusion Criteria:

1. Prior treatment with more than 1 cycle of azacitidine or decitabine.

2. Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.

3. Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.

4. Previous diagnosis of malignant tumor.

5. History of immune deficiency.

6. Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.