NCT01362530

A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of open-label aprepitant.

Conditions

• Chemotherapy Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant 125 mg	On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
DRUG	Aprepitant 80 mg	On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
DRUG	Aprepitant powder for suspension (PFS)	On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to \<12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to \<12 years of age
DRUG	Ondansetron	Day 1: Administered according to product label for pediatric usage or local standard of care
DRUG	Placebo for Aprepitant 125 mg	On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
DRUG	Placebo for Aprepitant 80 mg	On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
DRUG	Placebo for Aprepitant PFS	On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to \<12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to \<12 years of age
DRUG	Emetogenic chemotherapy	Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."

Timeline

• Start date: 2011-09-13
• Primary completion: 2013-03-14
• Completion: 2013-08-16
• First posted: 2011-05-30
• Last updated: 2018-09-25
• Results posted: 2014-04-04