Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy

Phase 1

Completed

• Conditions: Emesis
• Interventions: Drug: Palonosetron

• Registration Number: NCT01046240
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-11
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function

Exclusion Criteria

• Pregnancy
• Serious concomitant diseases, in the invesgator´s criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
subcutaneous palonosetron	Palonosetron	subcutaneous palonosetron
Intravenous palonosetron	Palonosetron	Intravenous palonosetron: control arm (standard treatment)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.	1 week (post-chemotherapy)

Trial Locations

Locations (1)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain