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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

Tracking Information
First Submitted Date  ICMJE December 15, 2021
First Posted Date  ICMJE January 20, 2022
Last Update Posted Date January 20, 2023
Actual Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2022)		 Complete response [ Time Frame: During the first 24 hours after chemotherapy ]
No emetic episode and no rescue medication
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2022)
  • Complete response [ Time Frame: 24-120 hours post chemotherapy ]
    No emetic episode and no rescue medication
  • 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
  • Complete response [ Time Frame: up to 120 hours after chemotherapy ]
    The proportion of patients with complete response
  • 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
  • Number of emetic episodes [ Time Frame: up to 120 hours after chemotherapy ]
    Number of emetic episodes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chemotherapy-induced Nausea and Vomiting
Intervention  ICMJE
  • Drug: Palonosetron HCl Buccal Film 0.5 mg
    Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
  • Drug: IV Palonosetron 0.25 mg
    IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Study Arms  ICMJE
  • 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
    Intervention: Drug: Palonosetron HCl Buccal Film 0.5 mg
  • 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
    Intervention: Drug: IV Palonosetron 0.25 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2022)		 328
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew H Nieder, Ph.D. 415 516-9498 matthew@lppharma.com
Contact: Linhui Cai, MS +86 173-5003-2816 clh@lppharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05199818
Other Study ID Numbers  ICMJE LP-CT-PALO-202101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Xiamen LP Pharmaceutical Co., Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Xiamen LP Pharmaceutical Co., Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xiamen LP Pharmaceutical Co., Ltd
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP