NCT01762280已完成1 期
A Phase I Study of Famitinib Malate in Patients With Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose(MTD)
研究概览
简要总结
Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Famitinib in patients with solid tumor
详细描述
- To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- To determine the pharmacokinetic profile of Famitinib and its metabolites .
- To assess preliminary antitumor activity .
- To determine preliminary dose and regimen for phase II study .
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
- 是
入选标准
- •Histological confirmed advanced or metastatic solid tumor，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
- •no standard therapy protocol available according to patients'condition
- •both sex, age 18 to 65
- •Life expectancy more than 3 months
- •ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be corrected by medication
- •Subjects receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery
- •Understand and agree to sign informed consent form.
排除标准
- •Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)
- •Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using single agent therapy, >Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia, arrhythmia,cardiac function insufficiency
- •PT, APTT, TT, Fbg abnormal(PT>16s,APTT>43s,TT>21s,Fbg<2g/L), or have hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
- •Active peptic ulcer
- •Previously medication include sunitinib
- •More than 4 weeks since the last clinical trial
- •Pregnant or lactating women
- •Women of childbearing age do not take effective contraceptive measures
- •Allergies, or known allergy history to components of the drug
研究组 & 干预措施
Famitinib Malate
Experimental
Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily
干预措施: Famitinib Malate Capsule (Drug)
结局指标
主要结局
Maximum tolerated dose(MTD)
时间窗: 2 months
Dose-limiting toxicity(DLT)
时间窗: 2 months
次要结局
- Number of volunteers with adverse events(2 months)
- Pharmacokinetics(2 months)
- Objective response rate(2 months)
- Pharmacodynamics(2 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)Recurrent Nasopharyngeal CarcinomaMetastatic Nasopharyngeal CarcinomaNCT01392235Jiangsu HengRui Medicine Co., Ltd.58
Unknown
2 期
A Study of Famitinib in Patients With Gastrointestinal Stromal TumorGastrointestinal Stromal TumorNCT02336724Jiangsu HengRui Medicine Co., Ltd.88
Unknown
1 期
A Study of Tafetinib in Chinese Patients With Advanced Solid TumorNeoplasmsNCT02717741Nanjing Yoko Biomedical Co., Ltd.30
暂停
2 期
A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer (NSCLC)NCT02356991Jiangsu HengRui Medicine Co., Ltd.137
终止
2 期
A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine TumorNCT01994213Jiangsu HengRui Medicine Co., Ltd.53