Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe (TANNED)

Radboud University Medical Center

Status: Completed

Conditions: Testicular Cancer

Treatments: Other: Blood sampling - Pharmacokinetic assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04935255

TANNED

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

17 participants in 1 patient group

Single Arm

Description:

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.

Treatment:

Other: Blood sampling - Pharmacokinetic assessment