NCT01471548已完成1 期
A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of TKI258
研究概览
简要总结
The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained prior to any screening procedures
- •Advanced solid tumors
- •Agreement to remaining hospitalized
- •ECOG performance status of 0 or 1
- •Life expectancy of at least 3 months
- •Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
- •Demonstrate the specific hematological /blood chemistry laboratory values
排除标准
- •Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
- •Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
- •Patients with CNS and/or leptomeningeal disease metastases
- •Presence or history of thromboembolic or cerebrovascular events
- •Impaired cardiac function or clinically significant cardiac disease
- •Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- •Patients known to be HIV- or HBV- or HCV- positive
- •Patients with acute or chronic uncontrolled infection
- •Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
- •Patients who have been receiving anticoagulant therapy
- •Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
- •Patients who have been administering concomitant medication which may prolong the QTc interval
- •Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
- •Patients with a large volume of ascitic and/or pleural fluid which requires drainage
- •Patients with any bone fractures
- •Deemed otherwise unsuitable by the investigator
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TKI258
Experimental
dose escalation
干预措施: TKI258 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of TKI258
时间窗: 30 days
次要结局
- Antineoplastic activity based on the RECIST criteria(22 months)
研究者
研究点 (1)
Loading locations...
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