Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

Completed

• Conditions: Testicular Cancer
• Interventions: Other: Blood sampling - Pharmacokinetic assessment

• Registration Number: NCT04935255
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-22
• Study Start: 2021-08-11
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Blood sampling - Pharmacokinetic assessment	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.

Primary Outcome Measures

Name	Time	Method
Exposure to etoposide	24 hours after administration	Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant

Trial Locations

Locations (1)

Radboud UMC; 🇳🇱 Nijmegen, Netherlands