NCT01571648已完成1 期
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must satisfy the following criteria to be enrolled in the study:
- •Have a documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) 2008 classification
- •Age ≥ 20 years;
- •Written informed consent;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Resolution of any toxic effects of prior anti-cancer therapy; and
- •Negative urine or serum pregnancy test on females of childbearing potential.
排除标准
- •The presence of any of the following will exclude a patient from enrollment:
- •Treatment with chemotherapy, radiotherapy, or surgery within 4 weeks of study registration;
- •Pregnant or breast-feeding females;
- •Previous or concomitant malignancy other than MDS;
- •Significant active cardiac disease within the previous 6 months;
- •Uncontrolled systemic infection or
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
研究组 & 干预措施
Oral azacitidine
Experimental
干预措施: Oral azacitidine (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
时间窗: 1 month
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
次要结局
- PK- Maximum concentration in plasma (Cmax)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- PK-Terminal half-life (T1/2,z)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- PK-Apparent total body clearance (CL/F)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- Safety (type, frequency, severity, number of participants with adverse events)(Up to 2 years)
- PK-Apparent volume of distribution (Vz/f)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- Efficacy (Hematologic response and hematologic improvement)(Up to 2 years)
- PK- Time to maximum plasma concentration (Tmax)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- PK-Elimination rate constant (Kel)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
- PK-Area under the plasma concentration-time curve (AUC)(0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose)
研究者
研究点 (1)
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