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临床试验/NCT03075995
NCT03075995Unknown不适用

To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
the Best Mode for Takeing Lapatinib

研究概览

简要总结

Food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.

详细描述

Metastatic breast cancer is the leading cause of cancer-related death among women worldwide ,those overexpress the HER2 are associated with a higher risk. Lapatinib is approved for use to treat advanced metastatic breast cancer. The pharmacokinetic parameters of lapatinib have been characterized previously.It can reach steady state concentration after 6 or 7 days oral dosing, but the bioavailability is very different between different patients. The effect of food on lapatinib pharmacokinetics in humans was first examined in 19 healthy participants who were given single 100-mg doses with a high-fat breakfast. Food caused a 60% increase in the relative bioavailability of lapatinib.Another test showed that the bioavailability of lapatinib was 3 times more in low-fat diet than in emptiness.

Some investigators think that it can change the mode for taking lapatinib with food or without food to enhance the absorption.It may decrease the oral dose but the lapatinib can reach the same steady state concentration,so it can achieve maximum economic benefits.

By continuous change for lapatinib and fat diet, The change of lapatinib pharmacokinetic is lack of discussion. If the adverse reactions increase since the absorption of lapatinib increase, the existing research data are still lacking.

The trial By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib, emptiness or taken with fatty food, discuss the best mode of taking lapatinib with fatty food.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Advance breast cancer with her2 positive
  • •The patients are ready to use or using lapatinib for tumor treatment, and plans to keep the treatment for at least a month
  • •The ECOG score is 0 to 2
  • •hemoglobin≥ 9 gm/dL
  • •serum albumin concentration is normal
  • •ALT / AST / bilirubin<1.5UL
  • •creatinine clearance rate≥ 40 mL/min

排除标准

  • •Pregnancy or Pregnancy
  • •Stomach absorption dysfunction
  • •Difficulty in taking fatty food
  • •Severe heart disease or medical condition

研究组 & 干预措施

lapatinib administered with hight-fat breakfast

Experimental

干预措施: hight-fat breakfast (Other)

结局指标

主要结局

the Best Mode for Takeing Lapatinib

时间窗: 20 days

by examined the steady state plasa concentration of Lapatinib ,determine which is the best way to take lapatinib,with high-fat breakfast or on an empty stomach

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu fei

Associate Senior Doctor

Sun Yat-sen University

研究点 (1)

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