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

Last updated: January 19, 2023
Sponsor: Xiamen LP Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Vomiting

Colic

Effects Of Chemotherapy

Treatment

N/A

Clinical Study ID

NCT05199818
LP-CT-PALO-202101
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 malignantdisease; or chemotherapy non-naïve subject with histologically proven diagnosis ofcancer;
  4. Karnofsky index ≥ 50;
  5. Be scheduled to receive MEC to be administered on Day 1;

Exclusion

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 thestudy;
  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 3nausea in the 24 hours preceding chemotherapy;
  7. Ongoing vomiting from any organic etiology;
  8. Experienced nausea (moderate to severe or vomiting following any previouschemotherapy);
  9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapyduring 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 Design

Total Participants: 328
Study Start date:
March 01, 2022
Estimated Completion Date:
November 30, 2023

Study 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).

Connect with a study center

  • Ironwood Cancer & Research Centers

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Active - Recruiting

  • Watson Clinic

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • Lakes Research

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Florida Cancer Affiliates

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • Summit Cancer Care

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Edward H. Kaplan MD & Associates

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Orchard Healthcare research, Inc.

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Tri-County Hematology & Oncology Associates

    Massillon, Ohio 44646
    United States

    Active - Recruiting

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania 17325
    United States

    Active - Recruiting

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