Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

Study Overview
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Brief Summary
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The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Official Title
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A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy

Conditions
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Chemotherapy-Induced Nausea and Vomiting (CINV)

Intervention / Treatment
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* Drug: Comparator: fosaprepitant dimeglumine
* Drug: Comparator: Aprepitant
* Drug: Dexamethasone
* Drug: Dexamethasone
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater Patient is post menopausal or, if premenopausal, must use double-barrier contraception Exclusion Criteria: Patient has symptomatic primary or metastatic CNS malignancy Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6 Patient has vomited in the 24 hours prior to treatment Day 1 Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse Patient is pregnant or breast feeding

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: study medication | Drug: Comparator: fosaprepitant dimeglumine<br>* single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.<br>Drug: Dexamethasone<br>* Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.<br>Drug: Ondansetron<br>* single IV dose of 32 mg of ondansetron on Day 1.<br>|
| Active Comparator: 2<br>Arm 2: Active comparator | Drug: Comparator: Aprepitant<br>* Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).<br>Drug: Dexamethasone<br>* Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.<br>Drug: Ondansetron<br>* single IV dose of 32 mg of ondansetron on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy. | Overall (in the 120 hours following initiation of cisplatin chemotherapy). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy. | Delayed phase (25 to 120 hours following initiation of cisplatin). | 
| No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy. | Overall (the 120 hours following initiation of cisplatin chemotherapy) |