Overview

Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

Status:
Completed
Trial end date:
2021-02-11
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
BB 1101
Dexamethasone
Dexamethasone acetate
Fosaprepitant
Serotonin 5-HT3 Receptor Antagonists
Criteria
Inclusion Criteria:

- Is receiving a moderately or highly emetogenic chemotherapy agent/regimen or a
chemotherapy agent/regimen not previously tolerated due to vomiting

- Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky
score ≥60 (participants >16 years of age)

- Has a pre-existing functional central venous catheter available for study treatment
administration

- Is fosaprepitant naïve

- Has a predicted life expectancy ≥3 months

- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies: is not a woman of
childbearing potential (WOCBP) OR is a WOCBP and agrees to not be sexually active or
use a highly effective contraceptive method for at least 28 days prior to receiving
study treatment, during the treatment period, and for at least 30 days (or local
standard of care if longer) after the last dose of study treatment (including the
optional cycles)

- Has a negative highly sensitive pregnancy test (urine or serum as required by local
regulations) prior to the start of fosaprepitant administration in a given cycle if a
WOCBP

- Weighs at least 6 kilograms (kg)

Exclusion Criteria:

- 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

- 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

- Is mentally incapacitated or has a significant emotional or psychiatric disorder that,
in the opinion of the investigator, precludes study entry

- Is pregnant or breast feeding

- Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist

- 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 treatment or concomitant therapy to the participant

- Is a WOCBP who has a positive pregnancy test at screening (Cycle 1) or on Day 1 of
optional Cycles 2 or 3

- Has been started on systemic corticosteroid therapy within 72 hours prior to study
treatment administration or is expected to receive a corticosteroid as part of the
chemotherapy regimen. Exceptions apply

- Is taking excluded medications

- Has ever participated in a previous study of aprepitant or fosaprepitant or has taken
a non-approved (investigational) drug within the last 4 weeks

- Has a known history of QT prolongation or is taking any medication that is known to
lead to QT prolongation