NCT00243763终止1 期
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 64
- 试验地点
- 10
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple myeloma
- •Evidence of relapsed or refractory disease
排除标准
- •Intracranial disease or epidural disease
- •Clinically significant cardiac disease
- •Diabetes mellitus
结局指标
主要结局
Maximum tolerated dose
Dose limiting toxicity
Safety profile
次要结局
- Evaluation of pharmacokinetics and pharmacodynamics
研究者
研究点 (10)
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