NCT01023386已完成1 期
A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
研究概览
简要总结
This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely:
- •castrate resistant prostate cancer
- •non-small cell lung cancer
- •metastatic melanoma
- •muscle invasive bladder cancer
- •follicular lymphoma
- •diffuse large B-cell lymphoma
- •Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline
排除标准
- •Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea
- •Previous therapy with YM155
- •Patients with renal, hepatic or colorectal cancers
- •Inadequate bone marrow, renal and/or hepatic function
- •History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin
- •Participation in any clinical study within 4 weeks prior to start of the first dose of study medication
- •Known brain or leptomeningeal metastases
- •Active uncontrolled systemic infection at baseline
结局指标
主要结局
To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
时间窗: Day -1 up to and including Day of discharge (Day 11)
次要结局
- To identify the metabolic profile of YM155(Day -1 up to and including Day of discharge (Day 11))
- To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography(Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge))
研究者
研究点 (1)
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