Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00450853

Enrollment

Registered

2007-03-22

Start date

2005-04-30

Completion date

2005-11-30

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vomiting

Keywords

emesis, granisetron, pharmacokinetics, subcutaneous.

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.

Detailed description

5-HT3 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 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. Pharmacokinetics of SC and IV granisetron will be prospectively compared.

Interventions

DRUGgranisetron

Granisetron SC followed by granisetron IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Pregnancy * Serious concomitant diseases, in the invesgator´s criteria

Design outcomes

Primary

Measure	Time frame
Bioavailability	Approximately 6 weeks

Secondary

Measure	Time frame
Safety	Approximately 6 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026