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

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.

Study Overview

• Status: Completed
• Conditions: Nausea With Vomiting Chemotherapy-Induced
• Intervention / Treatment: Drug: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center, Inc.
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center PL DBA Florida Cancer Affiliates
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Edward H. Kaplan MD & Associates
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Hematology/Oncology
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Monongahela, Pennsylvania, United States, 15063
      • Monongahela Valley Hospital/ Regional Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A (Buccal 0.25 Mg); Palonosetron HCl Buccal Film 0.25 Mg	Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg; Dose equal to the iv control; Other Names: Buccal Film Low Dose
Experimental: B (Buccal 0.5 Mg); Palonosetron HCl Buccal Film 0.5 Mg	Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg; Dose twice that of iv control; Other Names: Buccal Film High dose
Active Comparator: C (IV Injection 0.25 Mg); IV palonosetron 0.25 Mg (ALOXI®)	Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution; iv control; Other Names: Control Standard Treatment (Aloxi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Acute Response	no emetic episode and no rescue medication during the first 24 hours after chemotherapy	first 24 hours after chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete delayed response	no emetic episode and no rescue medication	24-120 hours post chemotherapy
Complete response	no emetic episode and no rescue medication	up to 120 hours post chemotherapy
No nausea	visual analog scale (0-100 mm, 0=no, 100=severe) < 5 mm	up to 120 hours post chemotherapy
No significant nausea	visual analog scale (0-100 mm, 0=no, 100=severe) < 25 mm	up to 120 hours post chemotherapy
Complete protection	no emesis, no rescue therapy, no significant nausea (questionnaire)	up to 120 hours post chemotherapy
Number of emetic episodes	Number of emetic episodes	up to 120 hours post chemotherapy
Time to rescue medication	Time to rescue medication	up to 120 hours post chemotherapy
Time to treatment failure	time to first emetic episode or administration of rescue therapy, whichever occurred first	up to 120 hours post chemotherapy
Severity of nausea	Rhodes Index of Nausea, Vomiting and Retching (0-4, 0=no nausea, 4=severe nausea)	up to 120 hours post chemotherapy
Subject global satisfaction with therapy	visual analog scale (0-100mm, 0=not at all satisfied, 100=totally satisfied)	up to 120 hours post chemotherapy
Quality of life questionnaire	Functional Living Index-Emesis	up to 120 hours post chemotherapy

Collaborators and Investigators

• Sponsor: Xiamen LP Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Sanjit Nirmalanandhan, Ph.D., Ocala Oncology Center PL DBA Florida Cancer Affiliates

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neurotransmitter Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Palonosetron
• Other Study ID Numbers: LP-CT-PALO-202002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No