A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Tmax Cmax t1/2 AUC
研究概览
简要总结
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.
详细描述
The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.
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
- •late malignant tumor patients diagnosed with the pathological and/or cytological;
- •lack of the standard treatment or treatment failure;
- •18-65years, ECOG:0-1,Expected survival period >3 months;
- •stop medicine > 30 days if any other chemotherapy drugs be used.
- •HB≥90g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT ≥100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR≥60ml/min,TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF≥LLN.
- •Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months.
- •Volunteer, informed consent form (ICF) signed, compliance.
排除标准
- •Subject was diagnosed with other malignant tumors previously or meanwhile;
- •Participated in other clinical trials in four weeks;
- •Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);
- •Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;
- •Hypertension
- •Urine protein: ++, and urinary in 24 hours > 1.0g;
- •Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;
- •Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;
- •With artery/venous thrombotic before oral ALTN;
- •With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;
- •With Abnormal thyroid function;
- •With history of psychiatric drugs abuse or a mental disorder;
- •Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);
- •Have immunodeficiency history;
- •According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial.
研究组 & 干预措施
anlotinib
dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week
干预措施: anlotinib (Drug)
结局指标
主要结局
Tmax Cmax t1/2 AUC
时间窗: Up to 52 days
To collect point with single drug:H0/H0.5/H1/H2/H4/H8/H12/H24/H48/H72/H96/H120/H144/H/H168/H192/H216/H240 To collect point with multiple drug:d1/d2/d4/d7/d10/d14/d15/d21/d22/d28/d35/d42
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 21 days)