Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

Phase 2/3 Completed 53 enrolled M.D. Anderson Cancer Center Helsinn Healthcare SA · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.

Timeline

Start: 2017-05-03
Primary completion: 2022-02-14
Completion: 2022-02-14

Outcome

Missed primary endpoint

registry analysis (other test); Blinded Intervention Group vs Blinded Placebo Group; p = 0.98; Wilcoxon (Mann-Whitney) NCT03040726 ↗

paper There were no statistically significant between-group differences for the primary/secondary outcomes. PMID 33388382 ↗

Publications

Hui D, Puac V, Shelal Z, Liu D, Maddi R, Kaseb A, Javle M, Overman M, Yennurajalingam S, Gallagher C, Bruera E. Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial. J Pain Symptom Manage. 2021 Aug;62(2):223-232.e1. doi: 10.1016/j.jpainsymman.2020.12.023. Epub 2021 Jan 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Netupitant	Small molecule	—	Oral
Subject	Palonosetron	Other / unclassified	—	Oral