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Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron and Dexamethasone for the Prevention of Nausea

NCT00366834•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Detailed Description

A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
•Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
•At least 18 years of age.
•Is scheduled to receive their first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy regimen for the treatment of a solid malignant tumor as outlined in Section 8.1.1.
•Has an ECOG performance status of 0, 1, or 2.
•Hematologic and metabolic status must be adequate for receiving a moderately emetogenic regimen and meet the following criteria:
•* Total Neutrophils ≥ 1500/mm³(Standard units : ≥1.5 x 10\^9/L)
•* Platelets ≥ 100,000/mm³ (Standard units: ≥100.0 x 10\^9/L)
•* Bilirubin ≤ 1.5 x ULN
•* Liver enzymes must be below the following limits:
+12 more criteria

Exclusion Criteria

•Has previously received cytotoxic chemotherapy. A history of previous biological or hormonal therapy will be permitted.
•Is a female subject who is pregnant or lactating.
•Has received radiation therapy to the brain, abdomen, or pelvis in the ten days prior to the first dose of study medication or casopitant investigational product and/or will receive radiation therapy to the brain, abdomen, or the pelvis in the six days following the first dose of study medication (ZOFRAN and dexamethasone) or casopitant investigational product.
•Is scheduled to receive taxane therapy during cycle 1. Note that subjects will be permitted to receive taxane therapy in conjunction with one of the allowed MEC regimens during subsequent cycles.
•Has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea in the 24 hours preceding the first dose of study medication or casopitant investigational product.
•Has a known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been medically stable for at least 1 week prior to receiving the first dose of study medication or casopitant investigational product.
•Has history of documented peptic ulcer disease (via endoscopy or x-ray), active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the subject.
•Has a known hypersensitivity or contraindication to ZOFRAN, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.
•Has previously received an NK-1 receptor antagonist.
•Received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug other than casopitant during the study period.
+18 more criteria

Locations (223)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Hot Springs, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Concord, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Greenbrae, California, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

October 1, 2007

Completion Date

October 1, 2009

Last Updated

September 10, 2012

Enrollment

1,840

ACTUAL participants

Conditions

VomitingNauseaNausea and Vomiting, Chemotherapy-Induced

Interventions

Casopitant (GW679769) oral tablets

DRUG

Casopitant (GW679769) intravenous

DRUG

Dexamethasone intravenous

DRUG

Ondansetron oral tablets

DRUG

placebo

DRUG

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

NCT07169851

NauseaVomiting+2 more

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RECRUITING

Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis

NCT07403370

Solid TumoursOlanzapine+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis

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