NL-OMON39190已完成不适用
Effects of dosing time on the pharmacokinetics and pharmacodynamics of sunitinib. - Effects of dosing time of sunitinib on its drug levels
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
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
- 18 至 99（—）
入选标准
- •Age >= 18 years;;Histological or cytological confirmed diagnosis of advanced clear-cell renal cell carcinoma, GIST or pancreatic neuro-endocrine tumor, treated with sunitinib;;WHO performance score <= 1 at study entry (see appendix A of the protocol);;Any stable dose of sunitinib at study entry, defined as no dose change within 3 weeks prior to pharmacokinetics; ;Adequate hematological functions (ANC > 1.0 x 109/L, platelets > 100 x 1012/L);;Adequate liver and renal function defined as bilirubin concentration <= 2 x ULN, AST and ALT <= 2.5 x ULN, serum creatinin concentration <= 2 x ULN;;Written informed consent;;For patients with reproductive potential a reliable method of contraception (excluding oral contraceptives) must be used
排除标准
- •Pregnant or child nursing patients;;Serious illness or medical unstable condition requiring treatment, symptomatic CNS metastasis or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;;Major surgery within 2 weeks prior to start of the protocol;;Use of CYP3A4 inhibiting or inducing medication as listed in appendix C;;Patients who are unable to collect blood from;;Patients with known allergy to sunitinib or midazolam;;Patients unwilling or unable to give written informed consent
研究者
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