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

Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Drug: Palonosetron HCl Buccal Film 0.5 mg; Drug: IV Palonosetron 0.25 mg

Detailed Description

This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).

Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).

• Study Type: Interventional
• Enrollment (Anticipated): 328
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Matthew H Nieder, Ph.D.; Phone Number: 415 516-9498; Email: matthew@lppharma.com
• Study Contact Backup: Name: Linhui Cai, MS; Phone Number: +86 173-5003-2816; Email: clh@lppharma.com

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Ironwood Cancer & Research Centers
      • Contact: Mikhail Shtivelband, MD; Phone Number: 480-821-2838; Email: barbara.ramirez@ironwood.com
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • Pacific Cancer Medical Center
      • Contact: Ajit Maniam, Dr
  • Florida
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Watson Clinic
      • Contact: Shalini Mulaparthi, MD; Phone Number: 863-904-2482
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • Lakes Research
      • Contact: Eloy Roman, MD
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Florida Cancer Affiliates
      • Contact: Anju Vasudevan, MD; Phone Number: 352-732-4032
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • Summit Cancer Care
      • Contact: Mark Taylor, MD; Phone Number: 912-651-5771
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Recruiting
      • Edward H. Kaplan MD & Associates
      • Contact: Edward H Kaplan, MD
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • Orchard Healthcare Research, Inc.
      • Contact: Ira Oliff, MD; Phone Number: 224-534-7580; Email: jardinico@orchardhr.com
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • American Oncology Partners of Maryland, PA
      • Contact: Ralph Boccia, MD; Phone Number: 240-482-0526
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Recruiting
      • Hattiesburg Clinic Hematology/Oncology
      • Contact: John Hrom, MD; Phone Number: 601-261-1700; Email: gloria.simmons@forrestgeneral.com
  • Montana
    • Billings, Montana, United States, 59102
      • Recruiting
      • St. Vincent Frontier Cancer Center
      • Contact: Patrick Cobb, MD; Phone Number: 406-238-6290; Email: erin.juedeman@sclhealth.org
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Recruiting
      • Tri-County Hematology & Oncology Associates
      • Contact: Scott McGee, MD; Phone Number: 330-489-8118
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Recruiting
      • Gettysburg Cancer Center
      • Contact: Satish A Shah, MD; Phone Number: 717-334-4033

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female, at least 18-years of age;
2. Provide written informed consent;
3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
4. Karnofsky index ≥ 50;
5. Be scheduled to receive MEC to be administered on Day 1;

Exclusion Criteria:

1. Unable to understand or cooperate with study procedure；
2. Received any investigational drug 30 days prior to study entry；
3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
4. Enrollment in a previous study with palonosetron；
5. Seizure disorder requiring anticonvulsant medication;
6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
7. Ongoing vomiting from any organic etiology；
8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
10. Known contraindication to 5-HT3 antagonist or dexamethasone；
11. Scheduled to receive bone marrow or stem cell transplant during study;
12. Symptomatic primary or metastatic CNS malignancy;
13. Lactating female.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palonosetron HCl Buccal Film; Palonosetron HCl Buccal Film 0.5 mg 1 hr before administration of moderately emetogenic chemotherapy and normal saline injection 30 minutes before administration of moderately emetogenic chemotherapy	Drug: Palonosetron HCl Buccal Film 0.5 mg; Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
Active Comparator: Palonosetron IV Injection; Placebo buccal film 1 har before administration of moderately emetogenic chemotherapy and Palonosetron HCl Injection 0.25 mg 30 min before administration of moderately emetogenic chemotherapy	Drug: IV Palonosetron 0.25 mg; IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response	No emetic episode and no rescue medication	During the first 24 hours after chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response	No emetic episode and no rescue medication	24-120 hours post chemotherapy
Absence of nausea	Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication	up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Complete response	The proportion of patients with complete response	up to 120 hours after chemotherapy
Complete control	The proportion of patients with complete control	up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Number of emetic episodes	Number of emetic episodes	up to 120 hours after chemotherapy

Collaborators and Investigators

• Sponsor: Xiamen LP Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: LP-CT-PALO-202101

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