Chemotherapy Induced Nausea and VomitingPhase 3NCT01362530
A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)
A Phase 3 study testing Aprepitant 125 mg, Aprepitant 80 mg and Aprepitant powder for suspension (PFS) in people with Chemotherapy Induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
Trial summary
This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- Aprepitant 125 mg, Aprepitant 80 mg and Aprepitant powder for suspension (PFS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2011to 16 Aug 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cycle 1:
- Is 6 months to 17 years of age at time of study entry
- Is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of vomiting for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
- Is expected to receive ondansetron as part of their antiemetic regimen
- If female and has begun menses, must has a negative urine pregnancy test prior to
- randomization. A female who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
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- If >10 years old, have a Karnofsky score ≥ 60; if ≤ 10 years have a Lansky Play Performance score ≥ 60
- Have a predicted life expectancy of ≥ 3 months
- Optional Cycles 2-6:
- Participant has, in the opinion of the investigator, completed the preceding cycle of chemotherapy and related study procedures satisfactorily
Who cannot join
- Cycle 1:
- Has vomited in the 24 hours prior to Treatment Day 1
- Is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
- Has received or will receive radiation therapy to the abdomen or pelvis within a week prior to Treatment Day 1 or during the course of the study
- Is pregnant or breast feeding
- Is allergic to aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist
Show all 14Show fewer
- Has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting
- History of QT prolongation or taking other medicinal products that lead to QT prolongation
- Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug to the participant
- Has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam
- Has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen
- Is currently taking warfarin
- Optional Cycles 2-6:
- All exclusion criteria from Cycle 1 apply except for vomiting in the 24 hours prior to Treatment Day 1
About this study
Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients
This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of open-label aprepitant.
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- Aprepitant 125 mg, Aprepitant 80 mg, Aprepitant powder for suspension (PFS), Ondansetron, Placebo for Aprepitant 125 mg
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant 125 mgDrug
Also called MK-0869, Emend®
On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
Aprepitant 80 mgDrug
Also called MK-0869, Emend®
On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
Aprepitant powder for suspension (PFS)Drug
Also called MK-0869, Emend®
On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age
OndansetronDrug
Also called Zofran™
Day 1: Administered according to product label for pediatric usage or local standard of care
Placebo for Aprepitant 125 mgDrug
On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
Placebo for Aprepitant 80 mgDrug
On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
Placebo for Aprepitant PFSDrug
On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age
Emetogenic chemotherapyDrug
Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant Regimen | Experimental | Cycle 1:
Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
Optional Cycles 2-6:
Open-label aprepitant administered in the same manner as in Cycle 1. Receives: Drug: Aprepitant 125 mg; Drug: Aprepitant 80 mg; Drug: Aprepitant powder for suspension (PFS); Drug: Ondansetron; Drug: Emetogenic chemotherapy |
| Control Regimen | Placebo comparator | Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1. Receives: Drug: Ondansetron; Drug: Placebo for Aprepitant 125 mg; Drug: Placebo for Aprepitant 80 mg; Drug: Placebo for Aprepitant PFS; Drug: Emetogenic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1
Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.
Measured: 25 to 120 hours after the start of chemotherapy
Secondary outcomes (3)
Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1
Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.
Measured: 0 to 24 hours after initiation of chemotherapy
Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1
Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.
Measured: 0 to 120 hours after initiation of chemotherapy
Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1
Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.
Measured: 0 to 120 hours after initiation of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study start13 Sep 2011
- Primary completion14 Mar 2013
- Study completion16 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362530
- Sponsor's protocol ID
- 0869-208
- Status last verified
- Aug 2018
- First submitted
- 26 May 2011
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.
PubMed 25770814Kang HJ, Loftus S, DiCristina C, Green S, Pong A, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in paediatric subjects: An analysis by age group. Pediatr Blood Cancer. 2018 Oct;65(10):e27273. doi: 10.1002/pbc.27273. Epub 2018 Jun 12.
PubMed 29893452
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01362530
- Acronym / sponsor ID
- 0869-208
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2011 (actual)
- Primary completion
- 14 Mar 2013 (actual)
- Study completion
- 16 Aug 2013 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Posted 4 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of open-label aprepitant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant Regimen | Experimental | Drug: Aprepitant 125 mg, Drug: Aprepitant 80 mg, Drug: Aprepitant powder for suspension (PFS), Drug: Ondansetron, Drug: Emetogenic chemotherapyCycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1. |
| Control Regimen | Placebo comparator | Drug: Ondansetron, Drug: Placebo for Aprepitant 125 mg, Drug: Placebo for Aprepitant 80 mg, Drug: Placebo for Aprepitant PFS, Drug: Emetogenic chemotherapyCycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Is 6 months to 17 years of age at time of study entry
- Is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of vomiting for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
- Is expected to receive ondansetron as part of their antiemetic regimen
- If female and has begun menses, must has a negative urine pregnancy test prior to
- randomization. A female who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
Key exclusion criteria (14 listed)
- Has vomited in the 24 hours prior to Treatment Day 1
- Is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
- Has received or will receive radiation therapy to the abdomen or pelvis within a week prior to Treatment Day 1 or during the course of the study
- Is pregnant or breast feeding
- Is allergic to aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist
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 125 mgAlso: MK-0869, Emend®On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age | Drug | Aprepitant Regimen |
| Aprepitant 80 mgAlso: MK-0869, Emend®On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age | Drug | Aprepitant Regimen |
| Aprepitant powder for suspension (PFS)Also: MK-0869, Emend®On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age | Drug | Aprepitant Regimen |
| OndansetronAlso: Zofran™Day 1: Administered according to product label for pediatric usage or local standard of care | Drug | Aprepitant Regimen, Control Regimen |
| Placebo for Aprepitant 125 mgOn the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age | Drug | Control Regimen |
| Placebo for Aprepitant 80 mgOn the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age | Drug | Control Regimen |
| Placebo for Aprepitant PFSOn the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age | Drug | Control Regimen |
| Emetogenic chemotherapyAny moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used." | Drug | Aprepitant Regimen, Control Regimen |
Primary outcome
Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1
Time frame: 25 to 120 hours after the start of chemotherapy
Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.
3 secondary outcomes
Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1
Time frame: 0 to 24 hours after initiation of chemotherapy
Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1
Time frame: 0 to 120 hours after initiation of chemotherapy
Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1
Time frame: 0 to 120 hours after initiation of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25770814Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.
- Derived from this study: PubMed 29893452Kang HJ, Loftus S, DiCristina C, Green S, Pong A, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in paediatric subjects: An analysis by age group. Pediatr Blood Cancer. 2018 Oct;65(10):e27273. doi: 10.1002/pbc.27273. Epub 2018 Jun 12.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant 125 mg, Aprepitant 80 mg and Aprepitant powder for suspension (PFS) in people with Chemotherapy Induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
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 10 inclusion and 14 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 25 Sep 2018. 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. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1 (time frame: 25 to 120 hours after the start of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362530, which also lists 2 linked publications.
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 25 Sep 2018.