Clinical trial NCT00818259: A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 92
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 years of age.

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 one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants \<6 months of age.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
timeFrame: Up to 24 hours post fosaprepitant/aprepitant dose
measure: Maximum Plasma Concentration (Cmax) for Aprepitant
timeFrame: Up to 72 hours post fosaprepitant/aprepitant dose
measure: Time to Cmax (Tmax) for Aprepitant
timeFrame: Up to 72 hours post fosaprepitant/aprepitant dose
measure: Apparent Terminal Half-life (t1/2) for Aprepitant
timeFrame: Up to 72 hours post fosaprepitant/aprepitant dose
measure: Cmax for Fosaprepitant
timeFrame: Up to 72 hours post fosaprepitant dose
measure: Tmax for Fosaprepitant
timeFrame: Up to 72 hours post fosaprepitant dose
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 14 days after last dose of study drug (Up to 17 days)
measure: Number of Participants Discontinuing Study Drug Due to an AE
timeFrame: Day 1 up to Day 3
Secondary outcomes:
measure: Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age
timeFrame: Up to 24 hours post dexamethasone dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.