IV Decitabine: The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.
Decitabine and cedazuridine: subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.
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.
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete Response Rate — An analysis is planned when the last enrolled patient have completed Follow-up 12 months. Assess efficacy \[Complete Response Rate (CR)\] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);
5day_AUC0-τ — An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day. Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days;
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou
Zhejiang
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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