NCT00823355已完成1 期
A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Mundipharma K.K.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年1月最近更新:
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
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate pharmacokinetics (PK) of oral BCX1777
研究概览
简要总结
Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777.
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
- •Histologically documented with histopathological diagnosis from biopsy, T/NK-cell malignancies (WHO classification). Precursor T-cell lymphoblastic leukemia/lymphoma (T-ALL/T-LBL) should be excluded in this study
- •A patient with recurrent, relapse or refractory T/NK-cell malignancies who has received at lease one chemotherapeutic regimen
- •Age 20 or greater
- •Eastern Cooperative Oncology Group(ECOG) performance status:0,
- •Able to be hospitalized at least for 15 days from the first dose
- •In the case of subject with tumor cell rate of ≤25% in bone marrow, a patient who satisfies both of the following criteria.
- •Neutrophil count: ≥1,200/mm3
- •Platelet count: ≥75,000/mm3
- •In the case of CTCL, the tumor cell rate is handled as ≤25%.
- •Adequate Liver function: AST, ALT ≤ 5.0 x upper limit of normal (ULN)
- •Adequate Renal function: Creatinine Clearance (using cockcroft-Gault formula) ≥ 50mL/min
- •Life expectancy of at least 3 months
- •A patient who has given a written informed consent prior to the start of procedures proper to this study.
排除标准
- 未提供
研究组 & 干预措施
BCX1777
Experimental
干预措施: forodesine hydrochloride (Drug)
结局指标
主要结局
To evaluate pharmacokinetics (PK) of oral BCX1777
时间窗: March 2010
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
时间窗: March 2010
次要结局
- To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)(March 2010)
- To analyze cell surface marker in peripheral blood mononuclear cell(March 2010)
- To evaluate pharmacodynamics (PD) of oral BCX1777(March 2010)
- To evaluate the efficacy of oral BCX1777(March 2010)
研究者
研究点 (1)
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