Nausea and vomiting after using moderate emetogenic cytostatics such as etoposide and cisplatin for the treatment of patients with metastatic lung carcinoma. MedDRA version: 9.1 Level: LLT Classification code 10056989 Term: Nausea post chemotherapy
Conditions
Interventions
Trade Name: Emend
Product Code: EU/1/03/262
Pharmaceutical Form: Tablet
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the pharmacokinetics of etoposide with and without the addition of aprepitant in patients with metastatic lung carcinoma treated with the standard CE regimen.;Secondary Objective: To study the efficacy and safety of the addition of aprepitant to the anti-emetic regimen in patients with metastatic lung carcinoma treated with the standard CE regimen.;Primary end point(s): 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 subject to a drug interaction with aprepitant. CE can be classified as a highly emetogenic chemotherapautic regimen, and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined. | — |
Countries
Netherlands
Outcome results
None listed