NCT02810756已完成早期 1 期
Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentration
研究概览
简要总结
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Locally advanced or metastatic cancer;
- •Able and willing to give written consent;
- •WHO performance status of 0, 1 or 2;
- •Able and willing to undergo blood sampling for PK analysis;
- •Minimal acceptable safety laboratory values;
- •Negative pregnancy test for female patients with childbearing potential;
- •Able and willing to swallow oral medication.
排除标准
- •Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
- •Any treatment with CYP3A4, BCRP or PGP interfering drugs;
- •Patients who received treatment with Votrient(R) kess than 1 week ago;
- •Woman who are pregnant or breast feeding;
- •Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.
研究组 & 干预措施
Treated patients
Experimental
干预措施: New Pazopanib formulation (Drug)
结局指标
主要结局
Plasma concentration
时间窗: 24 hours
Concentration of pazopanib in plasma
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 week)
- Area under the plasma concentration versus time curve (AUC)(24 hours)
研究者
研究点 (1)
Loading locations...
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