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

Purpose

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.

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting	Drug: Experimental: aprepitant Drug: Experimental: fosaprepitant Drug: Comparator: ondansetron	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma concentration and PK parameters of aprepitant [ Time Frame: Predose up to 3 days post dose ] [ Designated as safety issue: No ]
Number of participants experiencing adverse events (AEs) [ Time Frame: Day 1 up to Day 17 ] [ Designated as safety issue: Yes ]
Number of participants discontinued from study to to AEs [ Time Frame: Day 1 up to Day 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	82
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part I - fosaprepitant/aprepitant/ondansetron Part I includes participants 12-17 years of age and has two treatment plans (fosaprepitant and aprepitant, and fosaprepitant only).	Drug: Experimental: aprepitant Part 1A (Completed): aprepitant 80 mg, orally (po), on Days 2 and 3 prior to chemotherapy for participants from 12-17 years of age. Participants will also receive ondansetron as per local standard of care. Aprepitant dosages may be adjusted based pharmacokinetic data. Other Names: Emend MK-0869 Drug: Experimental: fosaprepitant Part IA (completed): Day 1, fosaprepitant, intravenous (IV) at a dose of 115 mg for participants from 12-17 years of age. Participants will also receive ondansetron as per local standard of care. Other Names: Emend injection Fosaprepitant Dimeglumine MK-0517 Drug: Experimental: fosaprepitant Part IB: Day 1, fosaprepitant, IV at a dose of 150 mg for participants 12-17 years of age. Participants will also receive ondansetron as per local standard of care. Other Names: Emend injection Fosaprepitant Dimeglumine MK-0517 Drug: Comparator: ondansetron Ondansetron will be administered intravenously per local standard of care. Other Name: Zofran
Experimental: Part II - aprepitant/ondansetron Part II includes participants from birth to less than 12 year of age. Part II has 2 dosing levels of aprepitant (Step A and Step B).	Drug: Experimental: aprepitant Part II Step A (Completed): aprepitant, po, on Day 1 prior to chemotherapy at 47 mg/m^2 for participants 6 months to <12 years of age. Participants will also receive ondansetron as per local standard of care. Other Names: Emend MK-0869 Drug: Experimental: aprepitant Part II Step A: Day 1, aprepitant, po, at a dose of 2 mg/kg for Participants from 4 to 6 months of age, 1.0 mg/kg for 1-4 months, and 0.5 mg/kg for <1 month. Participants will also receive ondansetron as per local standard of care. Other Names: Emend MK-0869 Drug: Experimental: aprepitant Part II Step B (completed): Day 1, aprepitant, po at a dose of 74 mg/m^2 for participants from 2 to <12 years of age, and 1.3 mg/kg for 6 months to <2 years. Participants will also receive ondansetron as per local standard of care. Other Names: Emend MK-0869 Drug: Experimental: aprepitant Part II Step B: Day 1, aprepitant po, at a dose of 3 mg/kg for participants from participants from 4 to 6 months of age, 1.5 mg/kg for 1-4 months, and 0.75 mg/kg for <1 month.Participants will also receive ondansetron as per local standard of care Other Names: Emend MK-0869 Drug: Comparator: ondansetron Ondansetron will be administered intravenously per local standard of care. Other Name: Zofran
Active Comparator: Part III - ondansetron with/without IV dexamethasone Part III includes participants from birth to less than 12 years of age. Participants from Part III may continue to Parts IV and V.	Drug: Comparator: ondansetron Ondansetron will be administered intravenously per local standard of care. Other Name: Zofran
Experimental: Part IV - aprepitant/ondansetron with/without IV dexamethasone Part IV includes participants from birth to 12 years of age	Drug: Experimental: aprepitant Part IV: Day 1, aprepitant, po at a dose of 125 mg/kg for participants 12-17 years of age, 3 mg/kg for 4 months to < 12 years, 1.5 mg/kg for 1-4 months, and 0.75 mg/kg for <1 month; Part IV Days 2 and 3, aprepitant, po at a dose of 80 mg/kg for participants from 12-17 years of age, 2 mg/kg for 4 months to <12 years, 1.0 mg/kg for 1-4 months, and 0.5 mg/kg for <1 month. Participants will also receive ondansetron as per local standard of care. Other Names: Emend MK-0869 Drug: Comparator: ondansetron Ondansetron will be administered intravenously per local standard of care. Other Name: Zofran
Experimental: Part V - fosaprepitant/ondansetron Part V includes participants from 6 months to less than 12 years of age	Drug: Experimental: fosaprepitant Part V: Day 1, fosaprepitant, IV at a dose of 3 mg/kg for participants 6 months to <12 years of age. Participants will also receive ondansetron as per local standard of care. Other Names: Emend injection Fosaprepitant Dimeglumine MK-0517 Drug: Comparator: ondansetron Ondansetron will be administered intravenously per local standard of care. Other Name: Zofran

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818259

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 19 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00818259 History of Changes
Other Study ID Numbers:	0869-134, 2009_501
Study First Received:	January 6, 2009
Last Updated:	May 16, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 22, 2013