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Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04592198•Xiamen LP Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•With histologically or cytologically confirmed malignant disease;
•-. Be scheduled to receive the first course of MEC to be administered on Day 1
•Using reliable contraceptive measures;
•negative serum pregnancy test (if potentially child bearing)

Exclusion Criteria

•Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
•Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
•Have severe renal or hepatic impairment;
•Have positive serology test results;
•Have a known contraindication to 5-HT3 receptor antagonists;
•Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
•Allergic to palonosetron or any other 5-HT3 antagonist;
•Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
•Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
•Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.

Locations (7)

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Ocala Oncology Center PL DBA Florida Cancer Affiliates

Ocala, Florida, United States

Edward H. Kaplan MD & Associates

Skokie, Illinois, United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Monongahela Valley Hospital/ Regional Cancer Center

Monongahela, Pennsylvania, United States

Charleston Oncology

Charleston, South Carolina, United States

Key Dates

Start Date

October 1, 2020

Primary Completion Date

March 25, 2021

Completion Date

March 25, 2021

Last Updated

March 24, 2025

Enrollment

ACTUAL participants

Conditions

Nausea With Vomiting Chemotherapy-Induced

Interventions

Palonosetron Hydrochloride Buccal Film 0.25 Mg

DRUG

Palonosetron Hydrochloride Buccal Film 0.5 Mg

DRUG

Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution

DRUG

BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

NCT04150614

Nausea With Vomiting Chemotherapy-Induced

View study

NOT_YET_RECRUITING

Predict CHimio-or Radiation-induced NAusea and Vomiting in Children/adolescents Treated for Cancer

NCT06869005

Childhood CancerNausea with Vomiting Chemotherapy-Induced

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

Predict CHimio-or Radiation-induced NAusea and Vomiting in Children/adolescents Treated for Cancer

The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children