NCT00450853

Brief Summary

Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

March 21, 2007

Last Update Submit

January 26, 2015

Conditions

Vomiting

Keywords

emesisgranisetronpharmacokineticssubcutaneous.

Outcome Measures

Primary Outcomes (1)

  • Bioavailability

    Approximately 6 weeks

Secondary Outcomes (1)

  • Safety

    Approximately 6 weeks

Study Arms (1)

Granisetron SC-Granisetron IV

EXPERIMENTAL

Granisetron SC followed by Granisetron IV

Drug: granisetron

Interventions

granisetronDRUG

Granisetron SC followed by granisetron IV

Also known as: Granisetron SC followed by granisetron IV
Granisetron SC-Granisetron IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients receiving platinum-based chemotherapy
  • adequate bone marrow, hepatic and renal function, respectively defined by: platelets \>100000/mm3 and absolute neutrophil count \>1500/mm3; bilirubin, AST and ALT \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl.
  • ECOG performance status \<2 and body mass index from 20-28 kg/m2.

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 Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alfonso Gurpide

    Oncology Department. Clinica Universitaria de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main investigator

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 22, 2007

Study Start

April 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

ES(1)