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

January 6, 2009
July 17, 2014
February 2009
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
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
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 ]
Not Provided
Not Provided
Not Provided
 
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 also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
    Interventions:
    • Drug: Experimental: aprepitant
    • Drug: Experimental: fosaprepitant
    • 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.
    Interventions:
    • Drug: Experimental: fosaprepitant
    • 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.
    Interventions:
    • Drug: Experimental: aprepitant
    • 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.
    Interventions:
    • Drug: Experimental: aprepitant
    • 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.
    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 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.
    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 also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
    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:

  • 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
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.
July 2014

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