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Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:
Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

Clinical Trial Summary

The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

Clinical Trial Description

This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC). Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05199818
Study type Interventional
Source Xiamen LP Pharmaceutical Co., Ltd
Contact Matthew H Nieder, Ph.D.
Phone 415 516-9498
Email matthew@lppharma.com
Status Recruiting
Phase Phase 3
Start date March 1, 2022
Completion date November 2023
View Details
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