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A Multicenter, Open-Label, Single-Arm Evaluation of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetoge

2014-07-23 21:11:01 | BioPortfolio

Summary

This study is designed to assess the safety and efficacy of palonesetron in preventing CINV (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Description

Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat chemotherapy induced nausea and vomiting (CINV) caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC

Intervention

palonesetron

Location

Sheridan Clinical Research
Sunrise
Florida
United States
33323

Status

Completed

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:01-0400

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