NCT00031031已完成1 期
Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
KangLaiTe USA2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2001年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
研究概览
简要总结
The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.
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
- •Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist.
- •Patients with an estimated life-expectancy of at least 3 months
- •Patients with a Karnofsky Performance Score of at least 60%
- •Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography
- •Patients with adequate renal and hepatic function
- •Patients with adequate bone marrow status
排除标准
- 未提供
研究者
研究点 (2)
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