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

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01046240

Enrollment

Registered

2010-01-11

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emesis

Keywords

chemotherapy, emesis, palonosetron

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.

Interventions

DRUGPalonosetron

Palonosetron 3 mg administered SC or IV

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026