Trials / Withdrawn
WithdrawnNCT01596426
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years
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 2 to 5 Years)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd · Industry
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.
Detailed description
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sancuso | granisetron transdermal system |
| DRUG | IV granisetron | IV granisetron |
Timeline
- First posted
- 2012-05-11
- Last updated
- 2024-07-26
Source: ClinicalTrials.gov record NCT01596426. Inclusion in this directory is not an endorsement.