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

NCT04592198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-24

Study results available
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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.

Conditions

  • Nausea With Vomiting Chemotherapy-Induced

Interventions

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

Sponsors & Collaborators

  • Xiamen LP Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Sanjit Nirmalanandhan, Ph.D. · Ocala Oncology Center PL DBA Florida Cancer Affiliates

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-03-25
Completion
2021-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592198 on ClinicalTrials.gov