Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- Drug: IV Palonosetron 0.25 mg
- Registration Number
- NCT05199818
- Lead Sponsor
- Xiamen LP Pharmaceutical Co., Ltd
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 328
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Palonosetron IV Injection IV Palonosetron 0.25 mg 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 Palonosetron HCl Buccal Film Palonosetron HCl Buccal Film 0.5 mg 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
- Primary Outcome Measures
Name Time Method Complete response During the first 24 hours after chemotherapy No emetic episode and no rescue medication
- Secondary Outcome Measures
Name Time Method Absence of nausea 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 control 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
Complete response up to 120 hours after chemotherapy The proportion of patients with complete response
Number of emetic episodes up to 120 hours after chemotherapy Number of emetic episodes
Trial Locations
- Locations (13)
Orchard Healthcare research, Inc.
🇺🇸Skokie, Illinois, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Tri-County Hematology & Oncology Associates
🇺🇸Massillon, Ohio, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Edward H. Kaplan MD & Associates
🇺🇸Skokie, Illinois, United States
Hattiesburg Clinic Hematology/Oncology
🇺🇸Hattiesburg, Mississippi, United States
Lakes Research
🇺🇸Miami Lakes, Florida, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
Florida Cancer Affiliates
🇺🇸Ocala, Florida, United States