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

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ClinicalTrials.gov Identifier: NCT04592198
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Xiamen LP Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE October 1, 2020
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
Complete acute 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: October 30, 2020)
  • Complete delayed response [ Time Frame: 24-120 hours post chemotherapy ]
    no emetic episode and no rescue medication
  • Complete response [ Time Frame: up to 120 hours post chemotherapy ]
    no emetic episode and no rescue medication
  • No nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale (0-100 mm, 0=no, 100=severe) < 5 mm
  • No significant nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale (0-100 mm, 0=no, 100=severe) < 25 mm
  • Complete protection [ Time Frame: up to 120 hours post chemotherapy ]
    no emesis, no rescue therapy, no significant nausea (questionnaire)
  • Number of emetic episodes [ Time Frame: up to 120 hours post chemotherapy ]
    Number of emetic episodes
  • Time to rescue medication [ Time Frame: up to 120 hours post chemotherapy ]
    Time to rescue medication
  • Time to treatment failure [ Time Frame: up to 120 hours post chemotherapy ]
    time to first emetic episode or administration of rescue therapy, whichever occurred first
  • Severity of nausea [ Time Frame: up to 120 hours post chemotherapy ]
    Rhodes Index of Nausea, Vomiting and Retching (0-4, 0=no nausea, 4=severe nausea)
  • Subject global satisfaction with therapy [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale (0-100mm, 0=not at all satisfied, 100=totally satisfied)
  • Quality of life questionnaire [ Time Frame: up to 120 hours post chemotherapy ]
    Functional Living Index-Emesis
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
  • Complete delayed response [ Time Frame: 24-120 hours post chemotherapy ]
    no emetic episode and no rescue medication
  • Complete response [ Time Frame: up to 120 hours post chemotherapy ]
    no emetic episode and no rescue medication
  • No nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale < 5 mm
  • No significant nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale < 25 mm
  • Complete protection [ Time Frame: up to 120 hours post chemotherapy ]
    no emesis, no rescue therapy, no significant nausea
  • Number of emetic episodes [ Time Frame: up to 120 hours post chemotherapy ]
    Number of emetic episodes
  • Time to rescue medication [ Time Frame: up to 120 hours post chemotherapy ]
    Time to rescue medication
  • Time to treatment failure [ Time Frame: up to 120 hours post chemotherapy ]
    time to first emetic episode or administration of rescue therapy, whichever occurred first
  • Severity of nausea [ Time Frame: up to 120 hours post chemotherapy ]
    Likert scale
  • Subject global satisfaction with therapy [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale
  • Quality of life questionnaire [ Time Frame: up to 120 hours post chemotherapy ]
    Functional Living Index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
Official Title  ICMJE A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg (ALOXI®) for the Prevention of Chemotherapy-induced Nausea and
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.
Detailed Description This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Nausea With Vomiting Chemotherapy-Induced
Intervention  ICMJE
  • Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
    Dose equal to the iv control
    Other Name: Buccal Film Low Dose
  • Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
    Dose twice that of iv control
    Other Name: Buccal Film High dose
  • Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
    iv control
    Other Name: Control Standard Treatment (Aloxi)
Study Arms  ICMJE
  • Experimental: A (Buccal 0.25 Mg)
    Palonosetron HCl Buccal Film 0.25 Mg and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3
    Intervention: Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
  • Experimental: B (Buccal 0.5 Mg)
    Palonosetron HCl Buccal Film 0.5 Mg and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3
    Intervention: Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
  • Active Comparator: C (IV Injection 0.25 Mg)
    IV palonosetron 0.25 Mg (ALOXI®) and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3
    Intervention: Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 26, 2021
Actual Primary Completion Date March 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • With histologically or cytologically confirmed malignant disease;

    • Karnofsky index ≥ 50;
    • 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)
  • Be able to read, understand, and follow the study procedures and able to complete patient diary autonomously.

Exclusion Criteria:

  • Expect to be non-compliant with the study procedures;
  • Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent during Day 2 to 6 of the study;
  • Has any condition that could have been associated with a risk of emesis near or at the time of study drug administration;
  • Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
  • Experienced any vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria grade 2 or 3 or nausea within 24 hours preceding chemotherapy;
  • Have ongoing nausea or vomiting from any organic etiology;
  • 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.
  • Had non-chronic benzodiazepine, opioid or opioid like (e.g., tramadol hydrochloride) therapy initiated within 48 hours prior to study drug administration or is expected to receive within 120 hours following initiation of chemotherapy, except for single daily doses of midazolam, temazepam or triazolam.
  • Started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of chemotherapy regimen.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592198
Other Study ID Numbers  ICMJE LP-CT-PALO-202002
Has Data Monitoring Committee No
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
Responsible Party Xiamen LP Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Xiamen LP Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xiamen LP Pharmaceutical Co., Ltd
Verification Date May 2021

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