Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

Study Overview
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Brief Summary
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This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

Detailed Description
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Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

Official Title
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See Detailed Description

Conditions
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Nausea and Vomiting, Chemotherapy-Induced

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Ondansetron
* Drug: GW679769
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. Diagnosed with a solid malignant tumour and has not previously received chemotherapy. Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria: Not received any investigational product within 30 days of enrolment into the study. Must not be pregnant. Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). Must not have a history of peptic ulcer disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aprepitant|nan|
|Drug: Ondansetron|nan|
|Drug: GW679769|nan|
|Drug: Dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV