Status:
TERMINATED
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE1
Brief Summary
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 ye...
Detailed Description
Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to...
Eligibility Criteria
Inclusion
- Is 0 (at least 37 weeks gestation) to 17 years of age
- Is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated
- Is expected to receive ondansetron
- Female participants who have begun menstruating must have a negative pregnancy test
- Weighs ≥3.0 kg if \<6 months of age, ≥6.0 kg if \>6 months of age, and ≥7.5 kg if \> 2 years of age
- Has a pre-existing venous catheter
Exclusion
- Uses any illicit drugs or abuses alcohol
- Is pregnant or breast feeding
- Has a symptomatic central nervous system (CNS) tumor
- Has an infection or other uncontrolled disease other than cancer
- Has known history of heart QT wave prolongation
Key Trial Info
Start Date :
February 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00818259
Start Date
February 5 2009
End Date
January 20 2014
Last Update
September 25 2018
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