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.
Upon completion of Cycle 1, participants were given the option to exit the study and be considered completed, or to continue on study therapy for up to 2 more (optional) 17-day cycles of chemotherapy where fosaprepitant was administered and additional safety data collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
103
Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
All participants received an oral 5-hydroxytryptamine (serotonin; \[5-HT\]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.
Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
Time frame: Up to 17 days
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who discontinue study treatment due to an AE is presented.
Time frame: Up to 3 days
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Phoenix Childrens Hospital ( Site 1101)
Phoenix, Arizona, United States
Southern California Permanente Medical Group ( Site 1104)
Los Angeles, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1106)
Chicago, Illinois, United States
Children's Hospitals and Clinics of Minnesota ( Site 1109)
Minneapolis, Minnesota, United States
St. Jude Children's Research Hospital ( Site 1111)
Memphis, Tennessee, United States
Athens Childrens Hospital Aglaia Kyriakou ( Site 0101)
Athens, Attica, Greece
University of Athens - Aghia Sophia Childrens Hospital ( Site 0102)
Athens, Attica, Greece
University General Hospital of Thessaloniki "AHEPA" ( Site 0103)
Thessaloniki, Greece
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0203)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0201)
Szeged, Csongrád megye, Hungary
...and 16 more locations