NL-OMON20410招募中不适用
Effect of moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib
KI-AV0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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
入选标准
- •Histological or cytological proof of cancer for which palbociclib is considered standard care;
- •Age = 18 years;
- •WHO performance status of 0, 1 or 2;
- •Adequate organ function per judgement of the treating physician;
- •Able and willing to undergo blood sampling for PK analysis.
排除标准
- •Concomitant use of medication(s) which could influence the pharmacokinetics of palbociclib within 14 days or five half-lives of the drug (whichever is shorter) before start of the study, consisting of (but not limited to) CYP3A4-inhibitors/inductors
- •Women who are pregnant or breast feeding;
- •Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
- •Palbociclib related side effects that would require a dose reduction per judgement of the treating physician;
- •QT duration corrected for heart rate > 450 ms or > 480 ms for subjects with bundle branch block.
研究者
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