Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

NCT ID: NCT04935255

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2022-06-23

Brief Summary

Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4.

Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP.

Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.

Conditions

Testicular Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Arm

The participating patients are treated according to local standard treatment (consisting of etoposide 100mg/m2 and cisplatin 20 mg/m2 during 5 consecutive days). Anti-emetic treatment with aprepitant will be given during days 3 to 7.

Blood sampling - Pharmacokinetic assessment

Intervention Type: OTHER

Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).

Interventions

Blood sampling - Pharmacokinetic assessment

Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with TC who will start or already started treatment with (B)EP
• Age of at least 18 years
• Patients from whom it is possible to collect blood samples
• Patients who are able and willing to give written informed consent prior to screening

Exclusion Criteria

• Patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong CYP3A4 inhibitor OR weak, moderate and strong inducers of CYP3A4 according to the table based on the Flockhart table (Appendix 1) less than 30 days prior to study or during the study.
• Creatininclearance <40 ml/min
• Severe liver dysfunction (bilirubin>ULN)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud UMC

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

TANNED

Identifier Type: -

Identifier Source: org_study_id