Testicular CancerTANNEDNCT04935255
Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe
An observational study of Testicular Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Blood sampling - Pharmacokinetic assessment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Aug 2021to 23 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe; an Observational Pharmacokinetic Study
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
- Being tested
- Blood sampling - Pharmacokinetic assessment
- Keywords
- aprepitant, etoposide, pharmacokinetic interaction, CYP3A4, clinical relevant interaction, pharmacokinetics
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling - Pharmacokinetic assessmentOther
Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sampling - Pharmacokinetic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to etoposide
Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant
Measured: 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start11 Aug 2021
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935255
- Sponsor's protocol ID
- TANNED
- Acronym
- TANNED
- Status last verified
- Sep 2022
- First submitted
- 15 Jun 2021
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe; an Observational Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT04935255
- Acronym / sponsor ID
- TANNED / TANNED
- Conditions
- Testicular Cancer
- Keywords
- aprepitant, etoposide, pharmacokinetic interaction, CYP3A4, clinical relevant interaction, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Other: Blood sampling - Pharmacokinetic assessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling - Pharmacokinetic assessmentTwo pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood). | Other | Single Arm |
Primary outcome
Exposure to etoposide
Time frame: 24 hours after administration
Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure to etoposide (time frame: 24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.