A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
研究概览
简要总结
The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen.
Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.
详细描述
Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Male
- 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
- •subject has an indication for treatment with BEP regimen
- •subject is expected to receive at least 2 cycles of BEP regimen
- •subject is able to swallow capsules
排除标准
- •documented history of sensitivity/idiosyncrasy to aprepitant or excipients
- •relevant history or condition that might interfere with drug absorption
- •history of or current abuse of drugs, alcohol or solvents
- •inability to understand nature and extent of the trial and the procedures
- •participation in a drug trial within 30 days prior to the first dose
- •febrile illness within 3 days before the first dose
- •use of agents that are known to interfere with aprepitant pharmacokinetics
- •abnormal liver or renal function
研究组 & 干预措施
aprepitant
Aprepitant treatment
干预措施: Aprepitant (Drug)
结局指标
主要结局
Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
Also at day 5 at the same time points blood samples will be taken.
次要结局
- Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.