None listed
Conditions
Interventions
Grupo de tratamiento Type of group
Active, Lyophilized powder for IV Injection 150 mg/vial, Participants 12 to 17 years of age:
Day 1: 115 mg
Days 2 and 3: 80 mg
Participants 6 months To
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting. See Appendix 8 for guidance on the classification of the emetogenicity of chemotherapeutic agents and regimens. 2. Have a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age) as defined in Appendix 9. 3. Have a preexisting functional central venous catheter available for study intervention administration. 4. Be fosaprepitant naïve. 5. Have a predicted life expectancy ≥3 months. 6. Be male or female. 7. Be from 6 months to 17 years of age (inclusive) at the time of allocation. 8. Weigh at least 6 kg. 9. Have parent/legal guardian (legally authorized representative) agreement to the participant’s participation as indicated by parent/legal guardian signature on the ICF. Participants 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled study visits. 10. Have completed the preceding study cycle, have no unresolved drug-related AEs, and continued participation in an optional cycle poses no unwarranted risk to the participant as determined by the investigator. 11. Have parent/legal guardian (legally authorized representative) or participant (if participant is 18 years old) agreement to the participant’s participation as indicated by parent/legal guardian or participant (if participant is 18 years old) signature on the ICF for the optional cycles. Participants 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled study visits. Please refer to the protocol for more information
Exclusion criteria
Exclusion criteria: 1. Has abnormal laboratory values as follows: -peripheral absolute neutrophil count (ANC) 5.0 × upper limit of normal (ULN) for age -alanine aminotransferase (ALT) >5.0 × ULN for age -bilirubin >1.5 × ULN for age -creatinine >1.5 × ULN for age 2. Will receive stem cell rescue therapy in conjunction with a study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant. 3. Is currently a user of any recreational or illicit drugs or has current evidence of drug or alcohol abuse or dependence as determined by the investigator. 4. Is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry. 5. Is pregnant or breast feeding. 6. Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist. 7. Has an active infection (eg, pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (eg, diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or has any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study intervention or concomitant therapy to the participant. 8. Is a WOCBP who has a positive urine pregnancy test at screening (Cycle 1) or on Day 1 of optional Cycles 2 or 3. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9. Has been started on systemic corticosteroid therapy within 72 hours prior to study intervention administration or is expected to receive a corticosteroid as part of the chemotherapy regimen. 10. Has received any medication within the timeframes listed in Table 1 or needs to receive any medication listed in Table 1 during the time period specified relative to the last dose of fosaprepitant in a given cycle (see Protocol) 11. Has ever participated in a previous study of aprepitant or fosaprepitant or has taken a non-approved (investigational) drug within the last 4 weeks. 12. Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation. Please refer to the protocol for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical review and quantification of adverse events, laboratory tests, vital signs, and ECG measurements. Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs. Timepoints:Cycle 01: From Treatment Day 1 through 14 days after the end of treatment. Cycle 02 y 03: From Treatment Day 1 through 14 days after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:NA Measure:NA Timepoints:NA | — |
Countries
Greece, Hungary, Lithuania, Mexico, Netherlands, Peru, Poland, Russian Federation, United Kindgdom, United States
Contacts
Public ContactRodolfo Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed