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

Primary Purpose

Emesis

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Palonosetron

About this trial

This is an interventional prevention trial for Emesis focused on measuring chemotherapy, emesis, palonosetron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous palonosetron

subcutaneous palonosetron

Arm Description

Intravenous palonosetron: control arm (standard treatment)

subcutaneous palonosetron

Outcomes

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.

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.

Full Information

NCT ID

NCT01046240

First Posted

November 24, 2009

Last Updated

January 26, 2015

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

1. Study Identification

Unique Protocol Identification Number

NCT01046240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emesis

Keywords

chemotherapy, emesis, palonosetron

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous palonosetron

Arm Type

Active Comparator

Arm Description

Intravenous palonosetron: control arm (standard treatment)

Arm Title

subcutaneous palonosetron

Arm Type

Experimental

Arm Description

subcutaneous palonosetron

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Intervention Description

Palonosetron 3 mg administered SC or IV

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

Time Frame

1 week (post-chemotherapy)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Belen Sadaba, MD, PhD

Organizational Affiliation

Clinica Universidad de Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinica Universidad de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24587006

Citation

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.

Results Reference

derived

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

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