NL-OMON32880尚未招募不适用
Predictive value of drug elimination gene polymorphisms on clearance and dose adjustment of sunitinib (Sutent, SU11248) in patients with cancer - CLEARS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age >18
- •* A malignancy treated with single agent sunitinib
- •* ECOG 0, 1 or 2 at time of study accruement
- •* Any stable dose of therapy with sunitinib (defined as no dose change
- •within 3 weeks prior to blood collection for pharmacokinetics)
- •* Adequate liver and renal function defined as serum bilirubin concentration
- •less than 2 x ULN, AST and ALT less than 2.5 x ULN, serum creatinine
- •concentration less than 2 x ULN
- •* No known primary liver disease and no other severe or uncontrolled
- •concurrent medical condition within the first 3 months of treatment with
- •* Patients who have participated on other clinical studies of sunitinib will be
- •suitable for this study.
- •* Signed informed consent
- •* Patients must not have Class 3/4 cardiac problems as defined by the New
- •York Heart Association criteria or any other severe or uncontrolled
- •concurrent medical disease.
- •* Patients must not be pregnant or nursing and must be using an effective
- •contraception method
排除标准
- •* Patients who are unable to sign informed consent
- •* Patients unable to give blood
- •* Patients with known midazolam allergies will not be included
- •* Patients must not be pregnant or nursing and must be using an effective
- •contraception method
- •* Patients who had a bone-marrow-transplantation prior to sunitinib
- •* Patients must not be taking routine systemic corticoid therapy
- •* Patients must not be taking therapeutic warfarin or warfarin derivates
- •doses as anticoagulation at the time of study tests with an at least 2 weeks
- •warfarin free period of time prior. Patients requiring anticoagulation may
- •use low-molecular weight heparin
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