Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

Summary

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

Timeline

Start

2012-09-24

Primary completion

2014-11-03

Completion

2014-11-03

Outcome

Mixed primary results

registry NUMBER Fosaprepitant Regimen: 78.9 Percentage of Participants NUMBER Control Regimen: 68.5 Percentage of Participants NCT01594749 ↗

registry analysis (superiority or other test); Fosaprepitant Regimen vs Control Regimen; p <0.001; Cochran-Mantel-Haenszel NCT01594749 ↗

registry NUMBER Fosaprepitant Regimen: 0.6 Percentage of Participants NUMBER Control Regimen: 0.0 Percentage of Participants NCT01594749 ↗

registry analysis (superiority or other test); Fosaprepitant Regimen vs Control Regimen; p = 0.085; Difference in percentage vs. Control 0.6 (95% CI -0.2 to 1.7); Miettinen & Nurminen method NCT01594749 ↗

Publications

• Results Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8.
• Weinstein C, Jordan K, Green S, Khanani S, Beckford-Brathwaite E, Vallejos W, Pong A, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020 Sep 25;20(1):918. doi: 10.1186/s12885-020-07259-5.
• Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Pong A, Noga SJ, Rapoport BL. Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial. Support Care Cancer. 2018 Nov;26(11):3773-3780. doi: 10.1007/s00520-018-4242-x. Epub 2018 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fosaprepitant dimeglumine	Unknown	150 mg	Intravenous
Background	Dexamethasone	Small molecule	12 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Ondansetron	Other / unclassified	8 mg	Oral
Background	Ondansetron	Other / unclassified	16 mg	Oral

Indications