JPRN-UMIN000002007已完成2 期
A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase - Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)
Shimousa Hematology Study Group0 个研究点目标入组 40 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry. 2) Patients whose clone exhibit the T315I BCR-ABL mutation. 3) Patients who have any cardiac disturbances. 4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
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