TANNED: Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04935255

Collaborator

(none)

Enrollment

Location

12.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Cancer	Other: Blood sampling - Pharmacokinetic assessment

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe; an Observational Pharmacokinetic Study

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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).

Arm

Intervention/Treatment

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.

Other: 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).

Outcome Measures

Primary Outcome Measures

Exposure to etoposide [24 hours after administration]
Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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)