The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
59
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
Time frame: During 24 hours after administration of chemotherapy.
Proportion of patients who achieved a CR and of those who achieved complete control
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
Number of emetic episodes
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
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