NauseaPhase 3NCT01661335
Efficacy of Aprepitant (Emend®) in Children
A Phase 3 study testing Ondansetron, dexamethasone, aprepitant in people with Nausea and Vomiting, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Nausea, Vomiting, Childhood Cancer
- What is being tested?
- Ondansetron, dexamethasone, aprepitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2012to 29 Jun 2017
- Phase
- Phase 3
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- under 20.99 years of age at enrollment
- Scheduled to receive two identical cycles of highly emetogenic[1] chemotherapy for treatment of a primary malignancy, including:
- Chemotherapy with any one or more of the following single agents in any combination:
- Carboplatin
- Carmustine >250 mg/m2
- Cisplatin
Show all 18Show fewer
- Cyclophosphamide ≥1 g/m2
- Dactinomycin
- High dose Methotrexate ≥ 5 g/m2
- Or any of the following defined combinations:
- Cyclophosphamide + anthracycline
- Cyclophosphamide + etoposide
- Cytarabine 150-200 mg/m2 + daunorubicin
- Cytarabine 300 mg/m2 + etoposide
- Cytarabine 300 mg/m2 + teniposide
- Doxorubicin + ifosfamide
- Doxorubicin + methotrexate 5 g/m2
- Etoposide + ifosfamide
Who cannot join
- Patients who have received aprepitant in the past.
- Patients who demonstrate evidence of increased intracranial pressure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, 73104
About this study
Official title: Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy
The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.
Read the detailed description
1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.
1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.
- Conditions
- Nausea, Vomiting, Childhood Cancer
- Being tested
- Ondansetron, dexamethasone, aprepitant, Ondansetron, Dexamethasone, placebo
- Keywords
- Nausea, Vomiting, Children, Aprepitant, Emend®
- Medical subject headings
- Nausea, Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron, dexamethasone, aprepitantDrug
Also called Aprepitant = Emend, ARM A
Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.
Ondansetron, Dexamethasone, placeboDrug
Also called ARM B
Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron, dexamethasone, aprepitant | Experimental | Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily. Receives: Drug: Ondansetron, dexamethasone, aprepitant |
| Ondansetron, Dexamethasone, placebo | Placebo comparator | Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%. Receives: Drug: Ondansetron, Dexamethasone, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of aprepitant (Emend®) measured through a complete response
- Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.
Measured: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.
- The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle.
- The total number of administrations of rescue medications given for breakthrough nausea or vomiting.
Measured: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life
- A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Measured: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
- A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
Measured: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Secondary outcomes (1)
Safety of aprepitant (Emend®)
- Occurrence of adverse events as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. These will be reported spontaneously or on inquiry by the investigator/study nurse, and continuously monitored throughout the trial.
- Weekly complete blood count (CBC) for 3 weeks after each investigational antiemetic cycle.
- Weekly complete metabolic profile (CMP) for 3 weeks after each investigational antiemetic cycle.
Measured: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start1 Jun 2012
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
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 University of OklahomaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene McNall-Knapp, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661335
- Sponsor's protocol ID
- 0413
- Status last verified
- Mar 2021
- First submitted
- 18 Jun 2012
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT01661335
- Acronym / sponsor ID
- 0413
- Conditions
- Nausea, Vomiting, Childhood Cancer
- Keywords
- Nausea, Vomiting, Children, Aprepitant, Emend®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 9 Aug 2012 (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 find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.
Detailed description
1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.
1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron, dexamethasone, aprepitant | Experimental | Drug: Ondansetron, dexamethasone, aprepitantArm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily. |
| Ondansetron, Dexamethasone, placebo | Placebo comparator | Drug: Ondansetron, Dexamethasone, placeboArm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%. |
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- under 20.99 years of age at enrollment
- Scheduled to receive two identical cycles of highly emetogenic[1] chemotherapy for treatment of a primary malignancy, including:
- Carboplatin
- Carmustine >250 mg/m2
- Cisplatin
Key exclusion criteria (2 listed)
- Patients who have received aprepitant in the past.
- Patients who demonstrate evidence of increased intracranial pressure.
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 |
|---|---|---|
| Ondansetron, dexamethasone, aprepitantAlso: Aprepitant = Emend, ARM AOndansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily. | Drug | Ondansetron, dexamethasone, aprepitant |
| Ondansetron, Dexamethasone, placeboAlso: ARM BOndansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%. | Drug | Ondansetron, Dexamethasone, placebo |
Primary outcome
Efficacy of aprepitant (Emend®) measured through a complete response
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
• Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
* The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle. * The total number of administrations of rescue medications given for breakthrough nausea or vomiting.
Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
1 secondary outcome
Safety of aprepitant (Emend®)
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
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 23 Mar 2021.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
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.
Rene McNall-Knapp, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron, dexamethasone, aprepitant in people with Nausea and Vomiting, run by University of Oklahoma at 1 site in United States.
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 18 inclusion and 2 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 23 Mar 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Efficacy of aprepitant (Emend®) measured through a complete response (time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen). The study lists 4 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 23 Mar 2021.