Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and… (NCT04054193) | Clinical Trial Compass
CompletedPhase 4
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
United States103 participantsStarted 2019-09-09
Plain-language 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.
Who can participate
Age range6 Months – 17 Years
SexALL
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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…
What they're measuring
1
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
Timeframe: Up to 17 days
2
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)