NCT00129207已完成1 期
Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available
- •Karnofsky Performance Status (KPS) equal to or greater than 70%
- •Normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less than 2 x upper limit of normal [ULN])
- •Total bilirubin equal to or less than 1.5 x ULN
- •Calculated creatinine clearance equal to or greater than 50 mL/min
- •Normal serum calcium
排除标准
- •Patients with significant cardiac disease
- •Equal to or greater than Grade 2 neuropathy
- •Active hepatitis
- •HIV infection
- •Secondary malignancy
- •Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment
- •Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4
研究者
研究点 (2)
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