Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis

Phase 3 Completed 212 enrolled Fudan University

RandomizedParallel-groupOpen-labelPrevention

Summary

Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement

Timeline

Start: 2014-12
Primary completion: 2021-12
Completion: 2021-12

Outcome

Met primary endpoint

paper The complete response rate in the delayed phase during Cycle 1 was significantly higher with mirtazapine than in the control group (78.3% versus 49.0%, P = 0.003). PMID 32036491 ↗

Publications

Cao J, Ouyang Q, Wang S, Ragaz J, Wang X, Teng Y, Wang B, Wang Z, Zhang J, Wang L, Wu J, Shao Z, Hu X. Mirtazapine, a dopamine receptor inhibitor, as a secondary prophylactic for delayed nausea and vomiting following highly emetogenic chemotherapy: an open label, randomized, multicenter phase III trial. Invest New Drugs. 2020 Apr;38(2):507-514. doi: 10.1007/s10637-020-00903-8. Epub 2020 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirtazapine	Other / unclassified	15 mg	—
Background	Aprepitant	Other / unclassified	80 mg	—