PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
NCT ID: NCT06091267
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2023-10-16
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ASTX727 and IV Decitabine
Cycle1：ASTX727 tablets, oral, 1 tablet/day for 5 days；Cycle2：IV Decitabine, 20 mg/m\^2, is administered for 1 hour at a time for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days
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.
IV Decitabine and ASTX727
Cycle1：IV Decitabine, 20 mg/m\^2, is administered for 1 hour at a time for 5 days； Cycle2：ASTX727 tablets, oral, 1 tablet/day for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days
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.
ASTX727
ASTX727 tablets, oral, 1 tablet/day for 5 days；
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Otsuka Beijing Research Institute
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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393-403-00072
Identifier Type: -
Identifier Source: org_study_id
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