An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: IV Decitabine (Drug)
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
干预措施: Decitabine and cedazuridine (Drug)
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
干预措施: only Decitabine and cedazuridine (Drug)
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
干预措施: IV Decitabine (Drug)
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
干预措施: Decitabine and cedazuridine (Drug)
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
干预措施: only Decitabine and cedazuridine (Drug)
ASTX727
ASTX727 tablets, oral, 1 tablet/day for 5 days；
干预措施: only Decitabine and cedazuridine (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 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
时间窗: 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;
次要结局
- Rate of transfusion independence(through study completion, an average of 1 year.)
- disease progression(through study completion, an average of 1 year.)
- Rac_AUC0-τ(through study completion, an average of 1 year.)
- Clinical Response Rate(through study completion, an average of 1 year.)
- peak concentration (Cmax)(through study completion, an average of 1 year.)
- Cmax(through study completion, an average of 1 year.)
- Objective Response Rate(through study completion, an average of 1 year.)
- time to peak concentration (Tmax)(through study completion, an average of 1 year.)
- area under the plasma concentration-time curve over a dosing interval (AUC0-τ).(through study completion, an average of 1 year.)
- Overall survival(through study completion, an average of 1 year.)
- Tmax(through study completion, an average of 1 year.)
- Rac_Cmax(through study completion, an average of 1 year.)
- Safety assessment(through study completion, an average of 1 year.)
- AUC0-τ(through study completion, an average of 1 year.)
- accumulation ratio based on AUC0-τ (Rac_AUC0-τ).(through study completion, an average of 1 year.)
- accumulation ratio based on Cmax (Rac_Cmax).(through study completion, an average of 1 year.)