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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046240
First Posted: January 11, 2010
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
  Purpose
This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.

Condition Intervention Phase
Emesis Drug: Palonosetron Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 29
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous palonosetron
Intravenous palonosetron: control arm (standard treatment)
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
Experimental: subcutaneous palonosetron
subcutaneous palonosetron
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046240


Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: Belen Sadaba, MD, PhD Clinica Universidad de Navarra
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01046240     History of Changes
Other Study ID Numbers: PAL/SC-IV-2008
2008-002853-19 ( EudraCT Number )
First Submitted: November 24, 2009
First Posted: January 11, 2010
Last Update Posted: January 27, 2015
Last Verified: November 2012

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
chemotherapy
emesis
palonosetron

Additional relevant MeSH terms:
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs