JPRN-UMIN000001927未知2 期
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase - Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)
Tokyo STI Study Group0 个研究点目标入组 50 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry. 2) Patients who are receiving treatment with other investigational agents. 3) Patients who exhibit the T315I BCR-ABL mutation. 4) Patients who have any cardiac disturbances. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug. 7) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.
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