NCT00905593Approved For Marketing不适用
An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 1
研究概览
简要总结
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on [CAMN107A2109] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having participated in Novartis study CAMN107A2109, and
- •Written signed and dated informed consent prior to any study procedures being performed.
排除标准
- •Impaired cardiac function,
- •Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
- •Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
- •patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
- •Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
- •Patients unwilling or unable to comply with the protocol.
- •Other protocol -defined inclusion/exclusion criteria may apply
研究者
研究点 (1)
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