EUCTR2018-004032-29-NL进行中（未招募）1 期
Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib
etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital0 个研究点目标入组 11 人开始时间: 2018年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histological or cytological proof of cancer for which palbociclib is considered standard care;
- •Age = 18 years;
- •Able and willing to give written informed consent;
- •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.
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
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;
- •Legal incapacity;
- •QT duration corrected for heart rate > 450 ms or > 480 ms for subjects with bundle branch block.
研究者
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