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

January 26, 2015 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intravenous palonosetron
Intravenous palonosetron: control arm (standard treatment)
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
EXPERIMENTAL: subcutaneous palonosetron
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment
Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment

Secondary Outcome Measures

Outcome 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.
Time Frame: 1 week (post-chemotherapy)
1 week (post-chemotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Belen Sadaba, MD, PhD, Clinica Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAL/SC-IV-2008
  • 2008-002853-19 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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