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

University of Navarra

Status and phase: Completed; Phase 2; Phase 1

Conditions: Emesis

Treatments: Drug: Palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01046240

PAL/SC-IV-2008

2008-002853-19 (EudraCT Number)

Details and patient eligibility

About

This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Intravenous palonosetron

Active Comparator group

Description:

Intravenous palonosetron: control arm (standard treatment)

Treatment:

Drug: Palonosetron

subcutaneous palonosetron

Experimental group

Description:

subcutaneous palonosetron

Treatment:

Drug: Palonosetron