Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy
5-Hydroxitryptamine3 antagonists are one of the mainstays of antiemetic treatment and they
are administered either intravenously or orally. Nevertheless sometimes neither
administration route is feasible, such as in patients unable to admit oral intake managed in
an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous
palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive
palonosetron 3 mg either subcutaneously or intravenously in a crossover manner during two
cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of
subcutaneous and IV palonosetron will be prospectively compared.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of area under the curve and Cmax in cancer patients treated with emetogenic chemotherapy.
Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment
Belen Sadaba, MD, PhD
Clinica Universidad de Navarra
Spain: Spanish Agency of Medicines