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

Radboud University Medical Center (Other)
Overall Status
CT.gov ID

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
  • Other: Blood sampling - Pharmacokinetic assessment

Study Design

Study Type:
Anticipated Enrollment :
12 participants
Observational Model:
Time Perspective:
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).

Outcome Measures

Primary Outcome Measures

  1. Exposure to etoposide [24 hours after administration]

    Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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)

Contacts and Locations


Site City State Country Postal Code
1 Radboud UMC Nijmegen Netherlands 6500HB

Sponsors and Collaborators

  • Radboud University Medical Center


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
First Posted:
Jun 22, 2021
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Radboud University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022