Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
研究概览
简要总结
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
- •At least one measurable lesion (by RECIST1.1)
- •Lack of the standard treatment or treatment failure
- •20≤BMI≤25
- •18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
- •Main organs function is normal
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- •Patients should participate in the study voluntarily and sign informed consent
排除标准
- •Clear allergies to the study drug or its ingredients
- •Had the disease to affect drug absorption and metabolism
- •Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- •Brain metastases patients with symptoms or symptoms controlled < 1 months
- •Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- •Patients participated in other anticancer drug clinical trials within 4 weeks
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
研究组 & 干预措施
Anlotinib(In the fasting state)
In the fasting state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Anlotinib(In the high fat diet state)
In the high fat diet state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
结局指标
主要结局
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
时间窗: up to 14 Days
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
时间窗: up to 14 Days
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).
次要结局
- Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）(up to 14 Days)