A Phase 1/2 interventional study of Palonosetron in Emesis, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 1/2, Interventional, and Prevention
This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 29 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
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Intravenous palonosetron: control arm (standard treatment)
Drug: Palonosetron
subcutaneous palonosetron
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
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.
Time frame: Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment
To compare the efficacy of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of number of episodes of nausea and vomiting in cancer patients treated with emetogenic chemotherapy.
Time frame: 1 week (post-chemotherapy)
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Clinica Universidad de Navarra, Universidad de Navarra