NCT01155713已完成1 期
A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
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
- 63
- 试验地点
- 4
- 主要终点
- Determine the effect of food on the bioavailability of TKI258
研究概览
简要总结
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
- •World Health Organization (WHO) performance status ≤ 2
- •Patient must meet protocol-specified laboratory values
排除标准
- •Patients with brain cancer
- •Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- •Patients who have not recovered from previous anti-cancer therapies
- •Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Arm 1 - TKI258 - bioavailability
Experimental
干预措施: TKI258 (Drug)
TKI258 - food effect
Experimental
干预措施: TKI258 (Drug)
结局指标
主要结局
Determine the effect of food on the bioavailability of TKI258
时间窗: food effect (22 days)
Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules)
时间窗: relative bioavailability (9 days)
次要结局
- Characterize the safety and tolerability of TKI258, including acute and chronic toxicities.(Up to 28 days after the last dose of study drug)
- Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.(Every 8 weeks until progression of disease)
研究者
研究点 (4)
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