A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.
详细描述
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be administered intravenously every 21 days. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe any anti-tumor effects of SN2310 Injectable Emulsion.
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
- 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
- •Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists
- •ANC > 1,500 cell/mm3, platelets > 100,000/mm3 and Hgb > 9 g/dl
- •At least one unidimensionally measurable lesion per RECIST
- •Negative serum or urine pregnancy test, if female of childbearing potential
排除标准
- •Female who is pregnant or lactating
- •History of chronic diarrhea
研究组 & 干预措施
A
SN2310 Injectable Emulsion
干预措施: SN2310 Injectable Emulsion (Drug)
结局指标
主要结局
Adverse Events
时间窗: December 2008
Maximum Tolerated Dose
时间窗: December 2008
Dose-Limiting Toxicity
时间窗: December 2008
Pharmacokinetic parameters for SN2310 and SN-38
时间窗: December 2008
次要结局
未报告次要终点