Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

Summary

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Timeline

Start

2008-02

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

paper Antiemetic protection with aprepitant and fosaprepitant was equivalent within predefined bounds for noninferiority. PMID 21383291 ↗

release “Single-Dose EMEND for Injection Regimen Achieved Superior Control of CINV” merck.com ↗

release “For the primary study endpoint, EMEND for Injection regimen provided higher incidence of CR in days 2 through 5” merck.com ↗

release “CR observed in 78.9 percent of patients receiving the EMEND for Injection regimen versus 68.5 percent in the active control group (p <0.001).” merck.com ↗

Publications

• Results Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aprepitant	Other / unclassified	80 mg	Oral
Subject	Fosaprepitant	Other / unclassified	150 mg	Intravenous
Comparator	Dexamethasone	Small molecule	8 mg	Oral
Background	Ondansetron	Other / unclassified	32 mg	Intravenous

Indications