Spots Global Cancer Trial Database for Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy
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Trial Identification
Brief Title: Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy
Official Title: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy
Study ID: NCT01046240
Conditions
Interventions
Study Description
Brief Summary: This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Contact Details
Name: Belen Sadaba, MD, PhD
Affiliation: Clinica Universidad de Navarra
Role: PRINCIPAL_INVESTIGATOR
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