A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134 AM3)

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any - 17
Updated:	3/1/2014
Start Date:	February 2009
End Date:	June 2015
Contact:	Toll Free Number
Phone:	1-888-577-8839

A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy

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 years of age.

Inclusion Criteria:

- Participant is 0 (at least 37 weeks gestation) to 17 years of age

- Participant 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

- Participant is expected to receive ondansetron

- Female participants who have begun menstruating must have a negative pregnancy test

- Participant 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

- Participant has a preexisting venous catheter

Exclusion Criteria:

- Participant uses any illicit drugs or abuses alcohol

- Participant is pregnant or breast feeding

- Participant has a symptomatic CNS tumor

- Participant has an infection or other uncontrolled disease other than cancer

- Known history of heart QT wave prolongation

We found this trial at

sites

Clinical Trial Facility in Washington District of Columbia

Washington, District of Columbia

from

Washington,