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: April 4, 2014
Last verified: April 2014

January 6, 2009
April 4, 2014
February 2009
January 2014   (final data collection date for primary outcome measure)
  • Plasma concentration and PK parameters of aprepitant and fosaprepitant [ 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 due to AEs [ Time Frame: Day 1 up to Day 3 ] [ Designated as safety issue: Yes ]
Plasma concentration and PK parameters of aprepitant and the safety and tolerability of fosaprepitant and aprepitant based on adverse experience monitoring [ Time Frame: throughout duration of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00818259 on ClinicalTrials.gov Archive Site
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A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chemotherapy-Induced Nausea and Vomiting
  • Drug: Experimental: aprepitant
    Other Names:
    • Emend
    • MK-0869
  • Drug: Experimental: fosaprepitant
    Other Names:
    • Emend injection
    • Fosaprepitant Dimeglumine
    • MK-0517
  • Drug: Comparator: ondansetron
    Other Name: Zofran
  • Drug: Ondansetron
  • Drug: Dexamethasone
  • 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 will also receive ondansetron IV as per local standard of care.
    Interventions:
    • Drug: Experimental: aprepitant
    • Drug: Experimental: fosaprepitant
    • Drug: Ondansetron
  • Experimental: Part 1B - fosaprepitant 150 mg
    Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to17 years of age. Participants will also receive ondansetron IV as per local standard of care, with or without IV dexamethasone.
    Interventions:
    • Drug: Experimental: fosaprepitant
    • Drug: Ondansetron
    • Drug: Dexamethasone
  • Experimental: Part II A - 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 will also receive ondansetron IV as per local standard of care.
    Interventions:
    • Drug: Experimental: aprepitant
    • Drug: Ondansetron
  • Experimental: Part II B- 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 will also receive ondansetron IV as per local standard of care.
    Interventions:
    • Drug: Experimental: aprepitant
    • Drug: Ondansetron
  • Active Comparator: Part III-ondansetron
    Ondansetron will be administered intravenously per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. IV dexamethasone is required on Day 1 in participants from birth to 1 year of age. It is optional in participants 1 year to <12 years of age.
    Interventions:
    • Drug: Comparator: ondansetron
    • 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 will also receive ondansetron IV as per local standard of care. IV dexamethasone is required on Day 1 in participants from birth to 1 year of age. It is optional in participants 1 year to <12 years of age.
    Interventions:
    • Drug: Experimental: aprepitant
    • 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 will also receive ondansetron IV as per local standard of care, with or without IV dexamethasone.
    Interventions:
    • Drug: Experimental: fosaprepitant
    • Drug: Ondansetron
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
92
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00818259
0869-134, 2009_501
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP