Determining the clinical relevance of the inTeraction between AprepitaNt aNd EtoposiDe; an observational pharmacokinetic study (TANNED-study)

Phase 4

Completed

• Conditions: testicular cancer; testicular germ cell tumor; 10013362

• Registration Number: NL-OMON50969
• Lead Sponsor: Afdeling Apotheek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the exposure (AUC0-24 hr) to etoposide in TC patients treated with (B)EP. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>