NCT01363479

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 743 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) 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.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Oral palonosetron
DRUG	I.V. palonosetron
DRUG	Dexamethasone

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-06-01
• Last updated: 2021-09-22
• Results posted: 2014-11-17

Locations

79 sites across 12 countries: United States, Argentina, Bulgaria, Croatia, Germany, Hungary, India, Italy, Poland, Romania, Russia, Ukraine