A pharmacokinetic evaluation of the addition of Aprepitant to the Cisplatin - Etoposide (CE) treatment of patients with metastatic lung carcinoma (ACE). - ACE

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2007年8月29日最近更新: 2022年4月4日

试验速览

暂无简介。

•1. Subject is at least 18 and not older than 75 years of age on the day of the first dosing.
•2. Subject is abel and willing to sing the Informed Consent Form prior to screening evaluations.
•3. Subject has an indication for treatment with CE regimen.
•4. Subject is expected to receive at least 2 cycles with CE regimen.
•5. Subject is able to swallow capsules.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Documented history of sensitivity/idiosyncrasy to aprepitant capsules or excipients.
•2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
•3. History of or current abuse of drugs, alcohol or solvents.
•4. Inability to understand the nature and extent of the trial and the procedures required.
•5. Participation in a drug trial within 30 days prior to the first dose.
•6. Febrile illness within 3 days before the first dose.
•7. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics (see appendix A)
•8. Abnormal liver or renal function, as indicated by serum liver enzymes >5 times ULN, total bilirubin >1.5 times ULN (see appendix B) or creatinine clearance <60 mL/min

发起方

Radboud University Nijmegen Medical Centre