An Open-label, Cross-over, Pharmacokinetic Study to Assess the Safety and Pharmacokinetics of Transdermal Granisetron (Sancuso® Patch) and IV Granisetron in a Pediatric Oncology Population (Aged 13 to 17 Years)

Kyowa Kirin Pharmaceutical Development Ltd12 sites in 1 country19 target enrollmentMay 2012

ConditionsChemotherapy Induced Nausea and Vomiting

Interventionsgranisetron transdermal system Granisetron IV

Drugsgranisetron transdermal system Granisetron IV

Overview

Phase: Phase 1
Intervention: granisetron transdermal system
Conditions: Chemotherapy Induced Nausea and Vomiting
Sponsor: Kyowa Kirin Pharmaceutical Development Ltd
Enrollment: 19
Locations: 12
Primary Endpoint: Plasma concentration
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

December 2016

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•13 to 17 years of age inclusive at screening.
•Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
•Written patient assent (as appropriate).
•Confirmed malignancy.
•Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
•Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.
•The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria

•Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
•Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
•Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
•Patients scheduled to have routine surgery during the study duration.
•Patients with a life expectancy of \< 6 months.
•Scarring or significant skin disease on both upper arms.
•Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
•Patients who are known or thought to be sexually active must use effective birth control.\*\*
•Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
•Any conditions associated with non-compliance.

Arms & Interventions

Sancuso Arm

Intervention: granisetron transdermal system

IV Granisetron Arm

Intervention: Granisetron IV

Outcomes

Primary Outcomes

Plasma concentration

Time Frame: Up to 7 days

Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.