NCT01278758终止1 期
A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 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
- •Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy;
- •Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
- •Creatinine clearance according to Cockcroft-Gault formula : Normal > 80 mL/min, Mild 50-80 mL/min, Moderate 30-<50 mL/min;
- •A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies;
- •Potassium, calcium, magnesium and phosphorus values within the normal range;
- •Body Mass Index (BMI) must be within the range of 18 and 30
排除标准
- •Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases;
- •Patients with leptomeningeal disease metastases;
- •Radiotherapy </- weeks prior to starting study drug;
- •Major surgery </ 4 weeks prior to the start of study;
- •Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug;
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ASA404 + standard therpy
Experimental
干预措施: ASA404, DMXAA or DXAA (Drug)
结局指标
主要结局
To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
时间窗: 12 months
次要结局
- To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
- To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function(12 months)
- To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
- To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function(12 months)
- To evaluate renal clearance (CLR) of ASA404.
研究者
研究点 (4)
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