At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.
In Brief
A Phase 3 clinical trial evaluating Palonosetron and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 441 participants across 76 sites in 9 countries.
Detailed Summary
PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy