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

NCT04592198 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LP-CT-PALO-202002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete Acute Response

  no emetic episode and no rescue medication during the first 24 hours after chemotherapy

  first 24 hours after chemotherapy

Study Arms (3)

A (Buccal 0.25 Mg)

EXPERIMENTAL

Palonosetron HCl Buccal Film 0.25 Mg

Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg

B (Buccal 0.5 Mg)

EXPERIMENTAL

Palonosetron HCl Buccal Film 0.5 Mg

Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg

C (IV Injection 0.25 Mg)

ACTIVE COMPARATOR

IV palonosetron 0.25 Mg (ALOXI®)

Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution

Interventions

Palonosetron Hydrochloride Buccal Film 0.25 Mg DRUG

Dose equal to the iv control

Also known as: Buccal Film Low Dose

A (Buccal 0.25 Mg)

Palonosetron Hydrochloride Buccal Film 0.5 Mg DRUG

Dose twice that of iv control

Also known as: Buccal Film High dose

B (Buccal 0.5 Mg)

Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution DRUG

iv control

Also known as: Control Standard Treatment (Aloxi)

C (IV Injection 0.25 Mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen LP Pharmaceutical Co., Ltd: lead

Study Sites (7)

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Ocala Oncology Center PL DBA Florida Cancer Affiliates

Ocala, Florida, 34474, United States

Location

Edward H. Kaplan MD & Associates

Skokie, Illinois, 60076, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Monongahela Valley Hospital/ Regional Cancer Center

Monongahela, Pennsylvania, 15063, United States

Location

Charleston Oncology

Charleston, South Carolina, 29406, United States

Location

MeSH Terms

Interventions

Palonosetron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Matthew H Nieder
• Organization: Xiamen LP Pharmaceutical Co.,Ltd

matthew@lppharma.com

(415) 516-9498

Study Officials

• Sanjit Nirmalanandhan, Ph.D.

  Ocala Oncology Center PL DBA Florida Cancer Affiliates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)