TumorPhase 4ACENCT00588835
Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
A Phase 4 study testing aprepitant and Dexamethasone and Ondansetron during CE-treatment in people with Tumor, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor
- What is being tested?
- aprepitant and Dexamethasone and Ondansetron during CE-treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2008to Jan 2010
- 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
- All sexes
- 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
- indication for treatment with CE regimen
- subject is expected to receive at least 2 cycles of CE regimen
- able to swallow capsules
Who cannot join
- history of sensitivity/idiosyncrasy to aprepitant or excipients
- condition that might interfere with drug absorption, distribution metabolism or excretion.
- history or current abuse of drugs, alcohol or solvents
- inability to understand the nature and extent of the trial and procedures
- participation in a drug trial within 30 days prior to the first dose
- febrile illness within 3 days before the first dose
- concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
- abnormal liver or renal function
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen
Radboud University Nijmegen Medical Centre
Nijmegen
About this study
Official title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
Read the detailed description
Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.
CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.
- Conditions
- Tumor
- Being tested
- aprepitant, Dexamethasone and Ondansetron during CE-treatment
- Keywords
- pharmacokinetics, nausea and vomiting post chemotherapy
- Medical subject headings
- Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called Emend
125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
Dexamethasone and Ondansetron during CE-treatmentDrug
Also called Decadron, Zofran
Standard anti-emetic regimen during CE treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment. Receives: Drug: aprepitant |
| B | Active comparator | CE cycle with standard anti-emetic regimen. Receives: Drug: Dexamethasone and Ondansetron during CE-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of etoposide will be measured
Measured: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
Secondary outcomes (1)
Nausea and emetic episodes are recorded
Measured: Day 1,3,5 and 8 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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 Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588835
- Sponsor's protocol ID
- UMCN-AKF 07.02
- Other IDs
- EudraCTnr 2007-003347-73
- Acronym
- ACE
- Status last verified
- Nov 2020
- First submitted
- 24 Dec 2007
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. 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 Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
- ClinicalTrials.gov ID
- NCT00588835
- Acronym / sponsor ID
- ACE / UMCN-AKF 07.02
- Conditions
- Tumor
- Keywords
- pharmacokinetics, nausea and vomiting post chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Jan 2008 (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 this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
Detailed description
Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.
CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: aprepitantAprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment. |
| B | Active comparator | Drug: Dexamethasone and Ondansetron during CE-treatmentCE cycle with standard anti-emetic regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- 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
- indication for treatment with CE regimen
- subject is expected to receive at least 2 cycles of CE regimen
- able to swallow capsules
Key exclusion criteria (8 listed)
- history of sensitivity/idiosyncrasy to aprepitant or excipients
- condition that might interfere with drug absorption, distribution metabolism or excretion.
- history or current abuse of drugs, alcohol or solvents
- inability to understand the nature and extent of the trial and 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 |
|---|---|---|
| aprepitantAlso: Emend125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well. | Drug | A |
| Dexamethasone and Ondansetron during CE-treatmentAlso: Decadron, ZofranStandard anti-emetic regimen during CE treatment | Drug | B |
Primary outcome
plasma concentrations of etoposide will be measured
Time frame: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
1 secondary outcome
Nausea and emetic episodes are recorded
Time frame: Day 1,3,5 and 8 of each cycle
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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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 Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aprepitant and Dexamethasone and Ondansetron during CE-treatment in people with Tumor, run by Radboud University Medical Center at 2 sites 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 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: stopped early, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 stopped early. Results are not available in the source record.
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?
plasma concentrations of etoposide will be measured (time frame: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3). 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 30 Nov 2020.