Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

Testicular Cancer Clinical Trial

— TANNED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935255
• Other study ID #: TANNED
• Status: Completed
• Start date: August 11, 2021
• Est. completion date: June 23, 2022

Study information

• Verified date: September 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Radboud UMC	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to etoposide	Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant	24 hours after administration