Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.

未提供0 个研究点目标入组 18 人开始时间: 2012年3月8日最近更新: 2012年7月10日

适应症

试验速览

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•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);
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

发起方

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