Clinical trial · Interventional
Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change of study population and chemotherapeutic regimen
Summary
Brief summary (as posted)
The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen. Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- aprepitant
- description
- Aprepitant treatment
- interventionNames
- Drug: Aprepitant
Primary outcomes (3)
- measure
- Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
- measure
- at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
- measure
- Also at day 5 at the same time points blood samples will be taken.
Secondary outcomes (1)
- measure
- Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * between 18 and 75 years of age * able and willing to sign Informed Consent Form * subject has an indication for treatment with BEP regimen * subject is expected to receive at least 2 cycles of BEP regimen * subject is able to swallow capsules Exclusion Criteria: * documented history of sensitivity/idiosyncrasy to aprepitant or excipients * relevant history or condition that might interfere with drug absorption * history of or current abuse of drugs, alcohol or solvents * inability to understand nature and extent of the trial and the procedures * participation in a drug trial within 30 days prior to the first dose * febrile illness within 3 days before the first dose * use of agents that are known to interfere with aprepitant pharmacokinetics * abnormal liver or renal function
References
Publications (0)
Data not yet available