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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
328
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
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
RECRUITINGPacific Cancer Medical Center
Anaheim, California, United States
Complete response
No emetic episode and no rescue medication
Time frame: During the first 24 hours after chemotherapy
Complete response
No emetic episode and no rescue medication
Time frame: 24-120 hours post chemotherapy
Absence of nausea
Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication
Time frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Complete response
The proportion of patients with complete response
Time frame: up to 120 hours after chemotherapy
Complete control
The proportion of patients with complete control
Time frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Number of emetic episodes
Number of emetic episodes
Time frame: up to 120 hours after chemotherapy
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Watson Clinic
Lakeland, Florida, United States
RECRUITINGLakes Research
Miami Lakes, Florida, United States
RECRUITINGFlorida Cancer Affiliates
Ocala, Florida, United States
RECRUITINGSummit Cancer Care
Savannah, Georgia, United States
RECRUITINGEdward H. Kaplan MD & Associates
Skokie, Illinois, United States
RECRUITINGOrchard Healthcare research, Inc.
Skokie, Illinois, United States
RECRUITINGAmerican Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
RECRUITINGHattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
RECRUITING...and 3 more locations