Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
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
1 other identifier
interventional
328
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2022
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJanuary 20, 2023
August 1, 2022
1.5 years
December 15, 2021
January 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response
No emetic episode and no rescue medication
During the first 24 hours after chemotherapy
Secondary Outcomes (5)
Complete response
24-120 hours post chemotherapy
Absence of nausea
up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Complete response
up to 120 hours after chemotherapy
Complete control
up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Number of emetic episodes
up to 120 hours after chemotherapy
Study Arms (2)
Palonosetron HCl Buccal Film
EXPERIMENTALPalonosetron 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
Palonosetron IV Injection
ACTIVE COMPARATORPlacebo 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
Interventions
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Eligibility Criteria
You may qualify if:
- Male or female, at least 18-years of age;
- Provide written informed consent;
- Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
- Karnofsky index ≥ 50;
- Be scheduled to receive MEC to be administered on Day 1;
You may not qualify if:
- Unable to understand or cooperate with study procedure；
- Received any investigational drug 30 days prior to study entry；
- Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
- Enrollment in a previous study with palonosetron；
- Seizure disorder requiring anticonvulsant medication;
- Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
- Ongoing vomiting from any organic etiology；
- Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
- Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
- Known contraindication to 5-HT3 antagonist or dexamethasone；
- Scheduled to receive bone marrow or stem cell transplant during study;
- Symptomatic primary or metastatic CNS malignancy;
- Lactating female.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Pacific Cancer Medical Center
Anaheim, California, 92801, United States
Watson Clinic
Lakeland, Florida, 33805, United States
Lakes Research
Miami Lakes, Florida, 33014, United States
Florida Cancer Affiliates
Ocala, Florida, 34474, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, 60076, United States
Orchard Healthcare research, Inc.
Skokie, Illinois, 60077, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Tri-County Hematology & Oncology Associates
Massillon, Ohio, 44646, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2021
First Posted
January 20, 2022
Study Start
March 1, 2022
Primary Completion
September 1, 2023
Study Completion
November 1, 2023
Last Updated
January 20, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share