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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
Dose equal to the iv control
Dose twice that of iv control
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Complete Acute Response
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Time frame: first 24 hours after chemotherapy
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Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Monongahela Valley Hospital/ Regional Cancer Center
Monongahela, Pennsylvania, United States
Charleston Oncology
Charleston, South Carolina, United States