NCT05199818

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Xiamen LP Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron HCl Buccal Film 0.5 mg	Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
DRUG	IV Palonosetron 0.25 mg	IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-09-01
• Completion: 2023-11-01
• First posted: 2022-01-20
• Last updated: 2023-01-20

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study