Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Study 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 in Colombia

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 Overview

• Status: Completed
• Conditions: Neoplasms; Nausea; Vomiting
• Intervention / Treatment: Drug: Palonosetron

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be 18 years of age or older.
• Histological or cytological confirmation of malignant disease.
• Karnofsky index >= 50%
• Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
• Patients that voluntarily sign the consent form.

Exclusion Criteria:

• Pregnancy or suspected.
• Patients during breast feeding.
• Inability to understand or cooperate with the study procedures.
• Received any investigational drugs within 30 days before study entry.
• Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
• Seizure disorders requiring anticonvulsant medication.
• Persistent vomiting due to any organic etiology.
• Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
• Any systemic disease different to base disease
• Known current or history of drug or alcohol abuse
• Gastric outlet or intestinal obstruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palonosetron; 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent	Drug: Palonosetron; 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.; Other Names: SCH 734291 - Onicit®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.	During 24 hours after administration of chemotherapy.

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who achieved a CR and of those who achieved complete control	Days 1 to 5 at different time intervals for each secondary outcome.
Number of emetic episodes	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	Days 1 to 5 at different time intervals for each secondary outcome.

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2007
• Primary Completion (Actual): February 22, 2008
• Study Completion (Actual): February 22, 2008

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 26, 2008

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Antiemetic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: P04935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Study Data/Documents

1. CSR Snyopsis