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
2 other identifiers
interventional
29
1 country
1
Brief Summary
This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 27, 2015
November 1, 2012
1.1 years
November 24, 2009
January 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Study Arms (2)
Intravenous palonosetron
ACTIVE COMPARATORIntravenous palonosetron: control arm (standard treatment)
subcutaneous palonosetron
EXPERIMENTALsubcutaneous palonosetron
Interventions
Palonosetron 3 mg administered SC or IV
Eligibility Criteria
You may qualify if:
- Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function
You may not qualify if:
- Pregnancy
- Serious concomitant diseases, in the invesgator´s criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Related Publications (1)
Sadaba B, del Barrio A, Campanero MA, Azanza JR, Gomez-Guiu A, Lopez-Picazo JM, Algarra SM, Guillen Grima F, 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.
PMID: 24587006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belen Sadaba, MD, PhD
Clinica Universidad de Navarra
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2009
First Posted
January 11, 2010
Study Start
October 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 27, 2015
Record last verified: 2012-11