NauseaPhase 4NCT00429754
Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
A Phase 4 study testing Aprepitant in people with Nausea and Vomiting, run by Radboud University Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2008
- Phase
- Phase 4
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
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.
Read the detailed description
Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.
- Being tested
- Aprepitant
- Keywords
- Nausea and vomiting after using cytostatic drugs
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
| Study group | Role | What they receive |
|---|---|---|
| aprepitant | Other | Aprepitant treatment Receives: Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
Also at day 5 at the same time points blood samples will be taken.
Secondary outcomes (1)
Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study completionSep 2008
Why it stopped: change of study population and chemotherapeutic regimen
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- David M. Burger, PharmD PhD, Principal investigator, Radboud University (RUNMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429754
- Sponsor's protocol ID
- UMCN-AKF 06.01
- Status last verified
- Jan 2016
- First submitted
- 31 Jan 2007
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
- ClinicalTrials.gov ID
- NCT00429754
- Acronym / sponsor ID
- UMCN-AKF 06.01
- Keywords
- Nausea and vomiting after using cytostatic drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change of study population and chemotherapeutic regimen
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study completion
- Sep 2008
- First posted
- 1 Feb 2007 (estimated)
- 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.
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.
Detailed description
Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aprepitant | Other | Drug: AprepitantAprepitant treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Aprepitant | Drug | aprepitant |
Primary outcome
Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
Also at day 5 at the same time points blood samples will be taken.
1 secondary outcome
Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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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.
David M. Burger, PharmD PhD principal investigator
Radboud University (RUNMC)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant in people with Nausea and Vomiting, run by Radboud University Medical Center.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic blood samples will be taken at day 2 at pre-dose,. The study lists 3 primary outcomes in all. 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 26 Jan 2016.