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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05199818
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Xiamen LP Pharmaceutical Co., Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Palonosetron HCl Buccal Film 0.5 mg Drug: IV Palonosetron 0.25 mg Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Complete response [ Time Frame: During the first 24 hours after chemotherapy ]
    No emetic episode and no rescue medication


Secondary Outcome Measures :
  1. Complete response [ Time Frame: 24-120 hours post chemotherapy ]
    No emetic episode and no rescue medication

  2. Absence of nausea [ Time Frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy ]
    Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication

  3. Complete response [ Time Frame: up to 120 hours after chemotherapy ]
    The proportion of patients with complete response

  4. Complete control [ Time Frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy ]
    The proportion of patients with complete control

  5. Number of emetic episodes [ Time Frame: up to 120 hours after chemotherapy ]
    Number of emetic episodes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05199818


Contacts
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Contact: Matthew H Nieder, Ph.D. 415 516-9498 matthew@lppharma.com
Contact: Linhui Cai, MS +86 173-5003-2816 clh@lppharma.com

Locations
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United States, Arizona
Ironwood Cancer & Research Centers Recruiting
Chandler, Arizona, United States, 85224
Contact: Mikhail Shtivelband, MD    480-821-2838    barbara.ramirez@ironwood.com   
United States, California
Pacific Cancer Medical Center Recruiting
Anaheim, California, United States, 92801
Contact: Ajit Maniam, Dr         
United States, Florida
Watson Clinic Recruiting
Lakeland, Florida, United States, 33805
Contact: Shalini Mulaparthi, MD    863-904-2482      
Lakes Research Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Eloy Roman, MD         
Florida Cancer Affiliates Recruiting
Ocala, Florida, United States, 34474
Contact: Anju Vasudevan, MD    352-732-4032      
United States, Georgia
Summit Cancer Care Recruiting
Savannah, Georgia, United States, 31405
Contact: Mark Taylor, MD    912-651-5771      
United States, Illinois
Edward H. Kaplan MD & Associates Recruiting
Skokie, Illinois, United States, 60076
Contact: Edward H Kaplan, MD         
Orchard Healthcare research, Inc. Recruiting
Skokie, Illinois, United States, 60077
Contact: Ira Oliff, MD    224-534-7580    jardinico@orchardhr.com   
United States, Maryland
American Oncology Partners of Maryland, PA Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ralph Boccia, MD    240-482-0526      
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: John Hrom, MD    601-261-1700    gloria.simmons@forrestgeneral.com   
United States, Montana
St. Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
Contact: Patrick Cobb, MD    406-238-6290    erin.juedeman@sclhealth.org   
United States, Ohio
Tri-County Hematology & Oncology Associates Recruiting
Massillon, Ohio, United States, 44646
Contact: Scott McGee, MD    330-489-8118      
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Satish A Shah, MD    717-334-4033      
Sponsors and Collaborators
Xiamen LP Pharmaceutical Co., Ltd
More Information
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Responsible Party: Xiamen LP Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT05199818    
Other Study ID Numbers: LP-CT-PALO-202101
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action