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

PHASE4CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

September 9, 2019

Primary Completion Date

February 11, 2021

Study Completion Date

February 11, 2021

Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
DRUG

Fosaprepitant Dimeglumine

Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).

DRUG

5-HT3 antagonist

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.

DRUG

Dexamethasone

Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.

Trial Locations (26)

1089

Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0202), Budapest

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0203), Miskolc

6720

Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0201), Szeged

15038

Instituto Nacional de Enfermedades Neoplasicas ( Site 1502), Lima

15073

Clinica Anglo Americana ( Site 1501), Lima

15074

Clinica Delgado ( Site 1503), Lima

38105

St. Jude Children's Research Hospital ( Site 1111), Memphis

50161

LSMUL Kauno Klinikos ( Site 0402), Kaunas

55404

Children's Hospitals and Clinics of Minnesota ( Site 1109), Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1106), Chicago

85016

Phoenix Childrens Hospital ( Site 1101), Phoenix

90027

Southern California Permanente Medical Group ( Site 1104), Los Angeles

115478

Blokhin National Medical Oncology ( Site 0701), Moscow

117198

Dmitry Rogachev National Research Center ( Site 0704), Moscow

197758

Clinical Research Center of specialized types medical care-Oncology ( Site 0706), Saint Petersburg

454076

Chelyabinsk Regional Children Clinical Hospital ( Site 0705), Chelyabinsk

115 27

Athens Childrens Hospital Aglaia Kyriakou ( Site 0101), Athens

University of Athens - Aghia Sophia Childrens Hospital ( Site 0102), Athens

546 36

"University General Hospital of Thessaloniki AHEPA ( Site 0103)", Thessaloniki

08406

Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0401), Vilnius

3584 CS

Prinses Maxima Centrum ( Site 0501), Utrecht

01-211

Instytut Matki i Dziecka ( Site 0601), Warsaw

04-730

Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0602), Warsaw

LS1 3EX

Leeds Teaching Hospitals NHS Trust ( Site 1002), Leeds

L12 2AP

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1003), Liverpool

M13 9WL

Royal Manchester Children's Hospital ( Site 1005), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04054193 - Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045) | Biotech Hunter | Biotech Hunter