A Study of Aprepitant (MK0869) and Fosaprepitant (MK0517) in Pediatric Patients Receiving Chemotherapy - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00818259

Purpose

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy induced nausea and vomiting in pediatric patients from 6 months to 17 years of age.

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting	Drug: aprepitant Drug: Comparator: fosaprepitant + aprepitant (Part I) Drug: Comparator: ondansetron Drug: Comparator: aprepitant (Part IV) Drug: Comparator: aprepitant + fosaprepitant (Part V)	Phase I

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma concentration and PK parameters of aprepitant and the safety and tolerability of fosaprepitatant and aprepitant based on adverse experience monitoring [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part I: Experimental aprepitant + fosaprepitant; This part is not yet enrolling patients	Drug: Comparator: fosaprepitant + aprepitant (Part I) Part I: Single dose intravenous fosaprepitant 115 mg on Day 1 prior to chemotherapy and oral aprepitant 80mg on Days 2 and 3 prior to chemotherapy
Part II: Experimental aprepitant	Drug: aprepitant Part II: Single dose oral aprepitant 47 mg/m2 or 74 mg/m2 on Day 1 prior to chemotherapy. Dosages may be adjusted based pharmacokinetic data.
Part III: Active Comparator ondansetron	Drug: Comparator: ondansetron Part III: ondansetron will be administered intravenously per local standard of care
Part IV: Experimental aprepitant	Drug: Comparator: aprepitant (Part IV) Patients in Part III will continue to Part IV Part IV: Oral aprepitant 74 mg/m2 on Day 1 followed by 47 mg/m2 on Days 2 and 3 of chemotherapy. Dosages may be adjusted based on pharmacokinetic data.
Part V: Experimental aprepitant + fosaprepitant; This part is not yet enrolling patients	Drug: Comparator: aprepitant + fosaprepitant (Part V) Patients from Part IV will continue to Part V Part V: Single dose intravenous fosaprepitant 68 mg/m2 on Day 1 of chemotherapy and oral aprepitant 47 mg/m2 on Days 2 and 3 of chemotherapy. Dosages may be adjusted based on pharmacokinetic data

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is scheduled to receive moderately to highly nausea-inducing chemotherapy or patient did not tolerate a previous chemotherapy regimen that is planned to be repeated
Patient will receive ondansetron
Female patients who have begun menstruating must have a negative pregnancy test
Patient weighs at least 6 kg (13.2 lbs)
Patient has a preexisting venous catheter

Exclusion Criteria:

Patient uses any illicit drugs or abuses alcohol
Patient is pregnant or breast feeding
Patient has a symptomatic CNS tumor
Patient has an infection or other uncontrolled disease other than cancer

Contacts and Locations

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Colorado
Call for Information	Recruiting
Aurora, Colorado, United States, 80045
Australia
Merck Sharp & Dohme (Australia) Pty Ltd.	Recruiting
South Granville, Australia, NSW 2142
Contact: David Woolner 64-9-523-6075
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90
Norway
MSD (Norge) AS	Recruiting
Drammen, Norway, 3011
Contact: Gunnar Saeter 47 32 20 7460
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728
Sweden
Merck Sharp & Dohme (Sweden) AB	Recruiting
Sollentuna, Sweden, 192 07
Contact: Roger Juhlin 46-8-626-1 458

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_501, MK0869-134
Study First Received:	January 6, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00818259 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Vomiting
Tranquilizing Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin
Antipruritics
Anti-Anxiety Agents
Nausea
Ondansetron
Peripheral Nervous System Agents
Aprepitant

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists

Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Ondansetron
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents
Aprepitant

ClinicalTrials.gov processed this record on May 06, 2009