Trial Information

Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy

This study involves prophylactic single dose of granisetron hydrochloride as a control in
the treatment of chemotherapy induced nausea and vomiting (CINV). The primary objective of
the study is to verify 0.75 mg palonosetron, concomitantly administered with
corticosteroids, is not inferior and superior to granisetron hydrochloride in acute stages 0
- 24 hours and in delayed stages 24 - 120 hours after administration of highly emetogenic
chemotherapy, respectively. Corticosteroids are commonly employed in current medical
treatments with 5-HT3 receptor antagonists.

This is a multicenter, parallel, group comparative study where subjects are assigned to
treatment groups in accordance with a central registration system. After obtaining written
informed consent, the patients that satisfy the inclusion criteria without meeting the
exclusion criteria are assigned using minimizing procedures to either a single-dose of 0.75
mg palonosetron group or a single-dose of 40 μg/kg granisetron hydrochloride with covariates
of chemotherapy regimen, gender and age. A palonosetron group will receive intravenous
injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration
of highly emetogenic chemotherapy. A granisetron hydrochloride group will be treated with
palonosetron placebo and then intravenous 40μg/kg granisetron hydrochloride before
administration of highly emetogenic chemotherapy. The onset of nausea and emetic episodes
and the time of an antiemetic procedure will be observed for 120 hours after the start of
highly emetogenic chemotherapy. The objective is to find the patients' global satisfaction
with the antiemetic therapy. Adverse events will also be observed for seven days after the
administration of the each drug.