Vomiting
Conditions
Brief summary
This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.
Detailed description
The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day cycles.
Interventions
DRUGaprepitant
aprepitant capsules
DRUGondansetron
ondansetron IV preparation
DRUGdexamethasone
dexamethasone tablets
Matching placebo to aprepitant capsules
Matching placebo to dexamethasone tablets
DRUGrescue medication
Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated. * Cycle 1: Participant has Karnofsky score ≥60 * Cycle 1: Participant has a predicted life expectancy of ≥3 months
Exclusion criteria
* Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Experience Absence of Nausea (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 |
| Percentage of Participants Who Experience Absence of Vomiting (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 |
| Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10) | Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months) |
| Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10) | Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months) |
| Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 |
| Percentage of Participants Who Experience Serious Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
| Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
| Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1) | Up to Day 4 of Cycle 1 |
| Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics | Up to 24 hours after first dose of aprepitant |
| Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10) | Up to Day 4 of Cycles 2-10 (Up to 10 months) |
Outcome results
None listed