跳至主要内容
临床试验/NCT01640730
NCT01640730终止2 期

An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment

KangLaiTe USA1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed (within last 3 months)progressive Stage IV NSCLC
  • estimated life span of 3 months
  • phase angle of at least 5 as measured by bioimpedance

排除标准

  • currently taking a lipid lowering medications
  • has an imminently life threatening condition
  • has pre-existing liver disease
  • known allergy to soybeans
  • uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
  • pregnant or lactating
  • has a pacemaker or other implantable electronic medical device

研究组 & 干预措施

Kanglaite injection

Experimental

干预措施: Kanglaite Injection (Drug)

结局指标

主要结局

Overall Survival

时间窗: from date of enrollment until date of death from any cause assessed up to 12 months

次要结局

  • Bioimpedance Phase Angle(measured each month up to one year)
  • Palliation Response Measure(each month up to one year)

研究者

发起方
KangLaiTe USA
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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