- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362530
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 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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aprepitant Regimen
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. |
On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
Other Names:
On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
Other Names:
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
Other Names:
Day 1: Administered according to product label for pediatric usage or local standard of care
Other Names:
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."
|
PLACEBO_COMPARATOR: Control Regimen
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.
|
Day 1: Administered according to product label for pediatric usage or local standard of care
Other Names:
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."
On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
25 to 120 hours after the start of chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1
Time Frame: 0 to 24 hours after initiation of chemotherapy
|
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.
|
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
|
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.
|
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
|
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.
|
0 to 120 hours after initiation of chemotherapy
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.
- Kang 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Neurokinin-1 Receptor Antagonists
- Ondansetron
- Aprepitant
- Fosaprepitant
Other Study ID Numbers
- 0869-208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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