Status:
ACTIVE_NOT_RECRUITING
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Eligibility Criteria
Inclusion
- Agree to participate in this trial and voluntarily sign the informed consent form.
- Men or women ≥ 18 years at the time of signing the informed consent form.
- Subjects with MDS previously treated or untreated with de novo or secondary MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
Exclusion
- Prior treatment with more than 1 cycle of azacitidine or decitabine.
- Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.
- Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
- Previous diagnosis of malignant tumor.
- History of immune deficiency.
- Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06091267
Start Date
October 16 2023
End Date
June 30 2026
Last Update
June 26 2025
Active Locations (1)
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1
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003