To investigate the influence of aprepitant on the exposure to etoposide in TC patients treated with (B)EP.
ID
Source
Brief title
Condition
- Testicular and epididymal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the exposure (AUC0-24 hr) to etoposide in TC patients treated with (B)EP.
Secondary outcome
Not applicable
Background summary
In metastatic testicular cancer, first-line chemotherapy consists of bleomycin,
etoposide and cisplatin (BEP) or etoposide and cisplatin (EP) in case of
contraindications for bleomycin.
As a result of the combination with cisplatin, this treatment is classified as
highly emetogenic. Depending on the degree of emetogenicity different
combinations of antiemetics are prescribed. The effectiveness of aprepitant in
combination with ondansetron and dexamethasone to prevent or reduce nausea was
demonstrated in several studies where aprepitant was seen to be particularly
effective in reducing late onset nausea.
In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of
CYP3A4 activity during the first days after administration and a moderate
inducer of CYP3A4 after cessation of therapy. Etoposide is metabolized by
CYP3A4, which may also make etoposide susceptible to interact with aprepitant.
The purpose of this study is to determine the clinical relevance of the
interaction between etoposide and aprepitant in patients with TC treated with
etoposide partly in combination with aprepitant. The results of this study can
contribute to optimize the antiemetic treatment for patients treated with high
emetogenic etoposide combination therapy.
Study objective
To investigate the influence of aprepitant on the exposure to etoposide in TC
patients treated with (B)EP.
Study design
single centre, prospective, open-label, observational pharmacokinetic study
Study burden and risks
Patients who participate in the study will receive standard treatment conform
local protocol. Therefore the risk for participation in this study is regarded
negligible. Collection of blood do not put patients at risk or interfere with
standard treatment.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000342-17-NL |
| CCMO | NL76372.091.21 |