drugset / Trial / NCT05199818

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

NCT05199818

Phase 3 Unknown 328 enrolled Xiamen LP Pharmaceutical Co., Ltd
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2022-03-01
Primary completion
2023-09
Completion
2023-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Palonosetron Other / unclassified 0.25 mg Other
Subject Palonosetron Other / unclassified 0.5 mg Other