CINV - 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) - 392MD/44/C (IRB# 39992)
- Principal Investigator: Andrew S. Freiberg, M.D.
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of the Sancuso® patch in children aged 13 to 17 years. PK is a way to study how the body processes a drug which will be measured at several time points after the dose has been given. Using these measurements, it is possible to see how quickly the drug is taken up by the body, how quickly it is broken down, when it reaches a steady level in the blood, and how long it remains in the body. In addition, the study will compare the PK of granisetron from the Sancuso® patch with intravenous (IV, or through a needle inserted in a vein) granisetron. The information gathered in this study will also be used to determine dosing of the Sancuso® patch in younger children aged 2 to 12 years.
To be eligible for inclusion into this study, each patient must fulfill all of the following criteria:
1. 13 to 17 years of age inclusive at screening.
2. Written patient or parental informed consent.
3. Written patient assent (as appropriate).
4. Confirmed malignancy.
5. Scheduled to receive 2 or more cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
6. 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.]
Additional Study Details:
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 13 to 17 years, who are receiving at least 2 cycles of chemotherapy of up to 5 days duration. Treatment with granisetron for one or more consecutive days must be considered appropriate for chemotherapy induced nausea and vomiting (CINV) prevention for each cycle. Sancuso® will be dosed first in all study patients followed by IV granisetron in the second cycle. As this is an open-label cross-over study, no treatment randomization will be performed.
Penn State Milton S. Hershey Medical Center
Pediatric Clinical Research Office