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

NCT05199818 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2023-01-20

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

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

Sponsors & Collaborators

  • Xiamen LP Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-09-30
Completion
2023-11-30
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 NCT05199818 on ClinicalTrials.gov