NCT01636947

A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)

A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC Regimes) With Broad Range of Tumor Types (KMEC Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens. The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant	Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
DRUG	Aprepitant Placebo	Aprepitant Placebo (PO, QD) on Days 1, 2, and 3
DRUG	Ondansetron	Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
DRUG	Dexamethasone	Dexamethasone (20 mg or 12 mg, PO) on Day 1
DRUG	Ondansetron Placebo	Ondansetron Placebo (PO, BID) on Days 2 and 3
DRUG	Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).	Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).

Timeline

• Start date: 2012-12-12
• Primary completion: 2014-08-04
• Completion: 2014-08-04
• First posted: 2012-07-10
• Last updated: 2018-09-25
• Results posted: 2015-07-30