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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01046240
First received: November 24, 2009
Last updated: February 19, 2014
Last verified: November 2012

November 24, 2009
February 19, 2014
October 2009
November 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of AUC 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01046240 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Treated With Platinum Chemotherapy
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Emesis
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
  • Active Comparator: Intravenous palonosetron
    Intravenous palonosetron: control arm (standard treatment)
    Intervention: Drug: Palonosetron
  • Experimental: subcutaneous palonosetron
    subcutaneous palonosetron
    Intervention: Drug: Palonosetron
Sadaba B, del Barrio A, Campanero MA, Azanza JR, Gomez-Guiu A, Lopez-Picazo JM, Algarra SM, Grimá FG, Blanco Prieto M, Perez-Gracia JL, Gurpide A. Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. PLoS One. 2014 Feb 27;9(2):e89747. doi: 10.1371/journal.pone.0089747. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01046240
PAL/SC-IV-2008, 2008-002853-19
No
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Not Provided
Principal Investigator: Belen Sadaba, MD, PhD Clinica Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP