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

NCT ID: NCT00818259

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-05
• Study Completion Date: 2014-01-20

Brief Summary

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.

Detailed Description

Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants <6 months of age.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental: aprepitant

Intervention Type: DRUG

aprepitant powder for suspension, 125 mg/sachet, PO

Experimental: fosaprepitant

Intervention Type: DRUG

fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: EXPERIMENTAL

Experimental: fosaprepitant

Intervention Type: DRUG

fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: EXPERIMENTAL

Experimental: aprepitant

Intervention Type: DRUG

aprepitant powder for suspension, 125 mg/sachet, PO

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: EXPERIMENTAL

Experimental: aprepitant

Intervention Type: DRUG

aprepitant powder for suspension, 125 mg/sachet, PO

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: ACTIVE_COMPARATOR

Comparator: ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: EXPERIMENTAL

Experimental: aprepitant

Intervention Type: DRUG

aprepitant powder for suspension, 125 mg/sachet, PO

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

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.

Group Type: EXPERIMENTAL

Experimental: fosaprepitant

Intervention Type: DRUG

fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV

Ondansetron

Intervention Type: DRUG

ondansetron solution for infusion, IV, administered per local standard of care

Dexamethasone

Intervention Type: DRUG

dexamethasone solution for infusion, IV, administered per local standard of care

Interventions

Experimental: aprepitant

aprepitant powder for suspension, 125 mg/sachet, PO

Intervention Type: DRUG

Experimental: fosaprepitant

fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV

Intervention Type: DRUG

Comparator: ondansetron

ondansetron solution for infusion, IV, administered per local standard of care

Intervention Type: DRUG

Ondansetron

ondansetron solution for infusion, IV, administered per local standard of care

Intervention Type: DRUG

Dexamethasone

dexamethasone solution for infusion, IV, administered per local standard of care

Intervention Type: DRUG

Other Intervention Names

Emend; MK-0869; Emend injection; Fosaprepitant Dimeglumine; MK-0517; Zofran

Eligibility 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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.

Reference Type: RESULT

PMID: 25770814 (View on PubMed)

Study Documents

Document Type: CSR Snyopsis

View Document

Other Identifiers

2009_501

Identifier Type: OTHER

Identifier Source: secondary_id

0869-134

Identifier Type: -

Identifier Source: org_study_id