392MD44/C, An open-label, cross-over, pharmacokinetic study to assess the safety and pharmacokinetics of transdermal granisetron (Sancuso(RegisteredTM) patch) and IV granisetron in a pediatric oncology population (aged 13 to 17 years)
This is an open-label, multi-center, cross-over Phase 2 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[RegisteredTM] will be dosed first in all study patients followed by iV granisetron in the second cycle.
a total of 16 patients aged 13 to 17 years will be recruited followed by an analysis to evaluate the PK profile of granisetron in this age group, using a population PK approach. This allows calculation of PK parameters for the included pediatric patients based on the sparse sampling regimen. The analysis will incorporate a review of the safety and PK data by a data review committee (comprising a Sponsor Safety Physician, Pharmacologist, Principal investigator, Statistician and Pediatric Clinical Pharmacologist) before dosing proceeds in a further study in a pediatric oncology population of a younger age group (Study 392MD/46/C [children aged 6 to 12 years]). The population PK model will also be used to determine whether adjustments to the Sancuso[RegisteredTM] dosing regimen are required for treatment of the younger age groups to be evaluated in Study 392MD/46/C (patients aged 6 to 12 years old) and Study 392MD/47/C (patients aged 2 to 5 years old).
1. 13 to 17 years of age inclusive at screening.
2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
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.