Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Phase 3 Completed 421 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Timeline

Start: 2009-08-25
Primary completion: 2010-04-04
Completion: 2010-05-05

Outcome

Met primary endpoint

paper 69.6% (142/204) and 57.0% (118/207) of patients reported CR during the OP in the aprepitant and standard therapy groups, respectively (P = 0.007). PMID 24276953 ↗

Publications

Results Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprepitant	Other / unclassified	80 mg	Oral
Background	Dexamethasone	Small molecule	3.75 mg	Oral
Background	Dexamethasone	Small molecule	7.5 mg	Oral
Background	Granisetron	Other / unclassified	3 mg	Intravenous