A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- plasma concentrations of etoposide will be measured
研究概览
简要总结
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
详细描述
Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.
CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 75 years of age
- •able and willing to sign informed consent form
- •indication for treatment with CE regimen
- •subject is expected to receive at least 2 cycles of CE regimen
- •able to swallow capsules
排除标准
- •history of sensitivity/idiosyncrasy to aprepitant or excipients
- •condition that might interfere with drug absorption, distribution metabolism or excretion.
- •history or current abuse of drugs, alcohol or solvents
- •inability to understand the nature and extent of the trial and procedures
- •participation in a drug trial within 30 days prior to the first dose
- •febrile illness within 3 days before the first dose
- •concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
- •abnormal liver or renal function
研究组 & 干预措施
A
Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
干预措施: aprepitant (Drug)
B
CE cycle with standard anti-emetic regimen.
干预措施: Dexamethasone and Ondansetron during CE-treatment (Drug)
结局指标
主要结局
plasma concentrations of etoposide will be measured
时间窗: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
次要结局
- Nausea and emetic episodes are recorded(Day 1,3,5 and 8 of each cycle)