Phase I Additional Study of Tolerance and Pharmacokinetics of Anlotinib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Anlotinib (in whole blood):Half life（t1/2）
研究概览
简要总结
A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological documentation of Advanced solid tumors except the digestive tract tumors,at least one measurable lesion (by RECIST1.1)
- •Lack of the standard treatment or treatment failure
- •18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
- •30 Days or more from the last cytotoxic therapy
- •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
- •Patients who are used by anlotinib
- •Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- •Brain metastases patients with symptoms or symptoms controlled < 3 months
- •Patients with any severe and/or unable to control diseases，including：
- •Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- •Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
- •Patients with active or unable to control serious infections;
- •Patients with cirrhosis, decompensated liver disease, or active hepatitis;
- •Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
- •Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
- •Patients with non-healing wounds or fractures
- •Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
- •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
- •History of immunodeficiency
- •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
干预措施: Anlotinib (Drug)
结局指标
主要结局
Pharmacokinetics of Anlotinib (in whole blood):Half life（t1/2）
时间窗: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H mans Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
时间窗: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle（D means Day）.
Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）
时间窗: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).
Pharmacokinetics of Anlotinib (in whole blood):Clearance（CL）
时间窗: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).
Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
时间窗: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).
Cumulative excretion of Anlotinib (in urine)
时间窗: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
次要结局
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD(Disease progression) (up to 24 months))