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)

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.

Timeline

Start

2012-12-12

Primary completion

2014-08-04

Completion

2014-08-04

Publications

• Results Kim JE, Jang JS, Kim JW, Sung YL, Cho CH, Lee MA, Kim DJ, Ahn MJ, Lee KY, Sym SJ, Lim MC, Jung H, Cho EK, Min KW. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017 Mar;25(3):801-809. doi: 10.1007/s00520-016-3463-0. Epub 2016 Nov 8.

Drugs

Indications

No indication recorded.