Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0
研究概览
简要总结
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients.
详细描述
Apatinib is a tyrosin-inhibitor agent targeting at VEGFR (vasoendothelial growth factor receptor) to inhibit tumor angiogenesis. The anti-angiogenesis effect of apatinib has been viewed in preclinical tests (see protocol). This phase I clinical study is going to evaluate its toxicity and to find an appropriate dose level to be used in a phase II study in heavily treated solid tumor patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and ≤ 70 years of age
- •Histological or cytological confirmed solid malignant tumor
- •ECOG performance status of ≤ 2
- •Standard regimen failed or no standard regimen available
- •Life expectancy of more than 3 months
- •Duration from the last therapy is more than 6 weeks for nitroso or mitomycin; more than 4 weeks for operation or radiotherapy; more than 4 weeks for cytotoxic agents or growth inhibitors.
- •Laboratory values: hemoglobin ≥ 9.0g/dl, neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L , ALT ≤ 2.5 x upper limit of normal (ULN), AST ≤ 2.5 x ULN, serum bilirubin ≤ 1.5 x ULN, serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, PT, APTT, TT, Fbg normal
排除标准
- •Pregnant or lactating women
- •Any factors that influence the usage of oral administration
- •Evidence of CNS metastasis
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- •Receiving the therapy of thrombolysis or anticoagulation
- •Abuse of alcohol or drugs
- •Allergy to the ingredient of the agent or more than two kinds of food and drug
- •Less than 4 weeks from the last clinical trial
- •Disability of serious uncontrolled intercurrence infection
研究组 & 干预措施
A
干预措施: apatinib (Drug)
结局指标
主要结局
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0
时间窗: 4 weeks
次要结局
- efficacy(every 8 weeks)