A Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron HCl Buccal Film versus IV Palonosetron 0.25 mg for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy
Details
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.
Eligibility
You can join if...
To participate in this study, you must meet the following criteria:
Be at least 18 years of age
Have a diagnosis of solid tumor cancer
Be scheduled to receive chemotherapy that is known to cause nausea and vomiting
You must be able to read, understand, and follow the study procedures
Be able to complete a subject diary on your own
Your assessed Karnofsky performance status should be not less than 50
If you have a seizure disorder that is unstable and require anticonvulsant medication, you cannot participate in this study
If your cardiovascular system, kidney or liver is impaired, you may participate only at the discretion of the study doctor
You cannot participate if you experienced moderate to severe nausea following any previous chemotherapy unless enrolled at the discretion of the study doctor
You cannot be in the study if you have any ongoing vomiting from any organic etiology, or if you have experienced any vomiting, retching, or National Cancer Institute (NCI) common Toxicity Criteria grade 2 or 3 or nausea in the 24 hours preceding chemotherapy
If you have symptomatic primary or metastatic CNS malignancy, you cannot participate.
You cannot participate if you will be receiving moderately-emetogenic chemotherapy or radiotherapy during Study Day 2-5 or highly-emetogenic chemotherapy or radiotherapy during Study Day 1-6 or will be receiving radiotherapy of the upper abdomen or cranium during Study Day 2
If you will be receiving bone marrow or stem cell transplant during the study, you cannot participate