NCT04592198

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg for the Prevention of CINV in Cancer Patients Receiving MEC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Xiamen LP Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

Detailed description

This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.

Conditions

• Nausea With Vomiting Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Palonosetron Hydrochloride Buccal Film 0.25 Mg	Dose equal to the iv control
DRUG	Palonosetron Hydrochloride Buccal Film 0.5 Mg	Dose twice that of iv control
DRUG	Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution	iv control

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2020-10-19
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study