A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR).
This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients with histologically confirmed advanced solid malignancies.
- •ECOG score 0-
- •18-65 years old.
- •Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks.
- •Function of organs must meet the following requirements:
- •Neutrophil count ≥1500/ul;
- •AST and ALT≤1.5 times the upper limit of normal (ULN);
- •Total serum bilirubin≤1.5 times ULN;
- •Hemoglobin≥90g/L;
- •Platelet≥100000/ul;
- •The creatinine in the normal range or creatinine clearance rate ≥60ml/min;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study.
- •Written informed consent is obtained.
排除标准
- •included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.
研究组 & 干预措施
tafetinib
tafetinib administered daily for 2 weeks, followed by a 1-week off period
干预措施: tafetinib (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 3 weeks
Dose-limiting toxicity was defined as any one of the following (NCI-CTCAE Version 4.0): (a) hypertension: uncontrollable grade 3 hypertensive or grade 4. (b) reduced LVEF: 2 degrees or above. (c) neutropenia : 3 degrees or above. (d) thrombopenia: 3 degrees or above. (e) Other Non-hematologic toxicity (not including alopecia, nausea or vomiting): 3 degrees or above.
次要结局
未报告次要终点