Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

NCT04935255 | Completed

• 1 other identifier: TANNED
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Cancer

Keywords

aprepitant; etoposide; pharmacokinetic interaction; CYP3A4; clinical relevant interaction; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Exposure to etoposide

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

  24 hours after administration

Study Arms (1)

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

Interventions

Blood sampling - Pharmacokinetic assessment OTHER

Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will exist of patients treated at the Radboudumc who are diagnosed with TC and are treated with (B)EP according to standard treatment guidelines.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud UMC

Nijmegen, 6500HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 22, 2021
• Study Start: August 11, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

NL (1)