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

NCT ID: NCT01046240

Last Updated: 2015-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Emesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravenous palonosetron

Intravenous palonosetron: control arm (standard treatment)

Group Type ACTIVE_COMPARATOR

Palonosetron

Intervention Type DRUG

Palonosetron 3 mg administered SC or IV

subcutaneous palonosetron

subcutaneous palonosetron

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

Palonosetron 3 mg administered SC or IV

Interventions

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Palonosetron

Palonosetron 3 mg administered SC or IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belen Sadaba, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universidad de Navarra

Locations

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Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 24587006 (View on PubMed)

Other Identifiers

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2008-002853-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PAL/SC-IV-2008

Identifier Type: -

Identifier Source: org_study_id

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