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

This study has been terminated.
(Study terminated early prior to completing targeted enrollment of participants <6 months of age due to recruitment challenges.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00818259
First received: January 6, 2009
Last updated: July 17, 2014
Last verified: July 2014
  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
Drug: Ondansetron
Drug: Dexamethasone
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma concentration and pharmacokinetic (PK) parameters of aprepitant and fosaprepitant [ Time Frame: Predose and 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 discontinuing from study due to AEs [ Time Frame: Day 1 up to Day 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentration and PK parameters of dexamethasone in participants from birth to 1 year of age [ Time Frame: Predose and up to 3 days post dose ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: February 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part IA-fosaprepitant 115 mg/aprepitant
Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: aprepitant
Other Names:
  • Emend
  • MK-0869
Drug: Experimental: fosaprepitant
Other Names:
  • Emend injection
  • Fosaprepitant Dimeglumine
  • MK-0517
Drug: Ondansetron Drug: Dexamethasone
Experimental: Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: fosaprepitant
Other Names:
  • Emend injection
  • Fosaprepitant Dimeglumine
  • MK-0517
Drug: Ondansetron Drug: Dexamethasone
Experimental: Part IIA-aprepitant 80 mg equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: aprepitant
Other Names:
  • Emend
  • MK-0869
Drug: Ondansetron Drug: Dexamethasone
Experimental: Part IIB-aprepitant 125 mg equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: aprepitant
Other Names:
  • Emend
  • MK-0869
Drug: Ondansetron Drug: Dexamethasone
Active Comparator: Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort. The birth to one year old cohort will be initiated upon completion of Part II (Steps A and B) in participants <6 months of age and will require the administration of dexamethasone IV on Day 1 as part of anti-emetic regimen.
Drug: Comparator: ondansetron
Other Name: Zofran
Drug: Dexamethasone
Experimental: Part IV-aprepitant regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort. The birth to one year old cohort will be initiated upon completion of Part II (Steps A and B) in participants <6 months of age and will require the administration of dexamethasone IV on Day 1 as part of anti-emetic regimen.
Drug: Experimental: aprepitant
Other Names:
  • Emend
  • MK-0869
Drug: Ondansetron Drug: Dexamethasone
Experimental: Part V-fosaprepitant regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: fosaprepitant
Other Names:
  • Emend injection
  • Fosaprepitant Dimeglumine
  • MK-0517
Drug: Ondansetron Drug: Dexamethasone

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00818259     History of Changes
Other Study ID Numbers: 0869-134, 2009_501
Study First Received: January 6, 2009
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Fosaprepitant
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists

ClinicalTrials.gov processed this record on August 01, 2014