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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 : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Xiamen LP Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Nausea With Vomiting Chemotherapy-Induced Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
Dose equal to the iv control
Other Name: Buccal Film Low Dose

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
Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
Dose twice that of iv control
Other Name: Buccal Film High dose

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
Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
iv control
Other Name: Control Standard Treatment (Aloxi)




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


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

  2. Complete response [ Time Frame: up to 120 hours post chemotherapy ]
    no emetic episode and no rescue medication

  3. No nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale (0-100 mm, 0=no, 100=severe) < 5 mm

  4. No significant nausea [ Time Frame: up to 120 hours post chemotherapy ]
    visual analog scale (0-100 mm, 0=no, 100=severe) < 25 mm

  5. Complete protection [ Time Frame: up to 120 hours post chemotherapy ]
    no emesis, no rescue therapy, no significant nausea (questionnaire)

  6. Number of emetic episodes [ Time Frame: up to 120 hours post chemotherapy ]
    Number of emetic episodes

  7. Time to rescue medication [ Time Frame: up to 120 hours post chemotherapy ]
    Time to rescue medication

  8. 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

  9. 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)

  10. 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)

  11. Quality of life questionnaire [ Time Frame: up to 120 hours post chemotherapy ]
    Functional Living Index-Emesis



Information from the National Library of Medicine

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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:

  • 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.

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): NCT04592198


Contacts
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Contact: Matthew H Nieder, Ph.D. 415 516-9498 matthew@lppharma.com
Contact: Linhui Cai, MS +86 141 55169498 clh@lppharma.com

Locations
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United States, California
Pacific Cancer Medical Center, Inc. Recruiting
Anaheim, California, United States, 92801
Contact: Elizabeth Brown, CRC    714-999-1465 ext 7    elizabethg@pacificcancer.com   
United States, Florida
Ocala Oncology Center PL DBA Florida Cancer Affiliates Recruiting
Ocala, Florida, United States, 34474
Contact: Sanjit Nirmalanandhan, Ph.D.    352-732-4032    sanjit.nirmalanandhan@usoncology.com   
United States, Illinois
Edward H. Kaplan MD & Associates Recruiting
Skokie, Illinois, United States, 60076
Contact: Edward H Kaplan, MD    847-675-3900    mregwell@yahoo.com   
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-288-2495      
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Terry Burke, BSN, RN    717-334-4033 ext 131    terry@gettysburgoncology.com   
Monongahela Valley Hospital/ Regional Cancer Center Recruiting
Monongahela, Pennsylvania, United States, 15063
Contact: Corey Brown    724-292-9204    corey@bioclin-research.com   
United States, South Carolina
Charleston Oncology Recruiting
Charleston, South Carolina, United States, 29406
Contact: Shelley Nichols    843-577-6957 ext 278    Shelley.Nichols@charlestononcology.com   
Sponsors and Collaborators
Xiamen LP Pharmaceutical Co., Ltd
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Responsible Party: Xiamen LP Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT04592198    
Other Study ID Numbers: LP-CT-PALO-202002
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
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