NCT01223898已完成1 期
An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor
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
- 19
- 试验地点
- 1
- 主要终点
- evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam in CML patients.
研究概览
简要总结
This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following extension study does evaluate the safety of nilotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 a cytopathologically confirmed diagnosis of Ph+ CML or Philadelphia chromosome- negative (Ph-) CML patients in accelerated or chronic phase who are resistant and/or intolerant against at least one prior therapy with a BCR-ABL tyrosine kinase inhibitor
- •Female or male ≥ 18 years of age
- •Patients who are nilotinib naïve at study entry, e.g. did not receive any nilotinib treatment prior to study
- •WHO Performance Status of ≤ 2
排除标准
- •Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- •Impaired cardiac function
- •History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- •Patients actively receiving therapy with the prohibited co-medications (CYP3A4 inhibitors or inducers, or CYP2C inducers)
- •Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval
- •Treatment with immunotherapy or chemotherapy within 3 days (6 weeks for nitrosurea or mitomycin-C) prior to Day 1 or who have not recovered from side effects of such therapy.
- •Treatment with imatinib within 1 week prior to Day 1 or who have not recovered from side effects of such therapy.
- •Patients who have hypersensitivity to midazolam or related compounds
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
Experimental
干预措施: Tasigna (Drug)
结局指标
主要结局
evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam in CML patients.
时间窗: 2 weeks
次要结局
- evaluate the safety and tolerability of multiple doses of nilotinib when midazolam is co-administered orally in CML patients.(2 weeks)
- Monitoring of safety of nilotinib during the extension study phase.(12 months)
研究者
研究点 (1)
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