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

Phase 3

Completed

• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
• Interventions: Drug: Dexamethasone; Drug: Ondansetron

• Registration Number: NCT00619359
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-28
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-01-19
• Results First Submitted QC: 2010-01-19
• Results First Posted: 2010-02-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2322

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Dexamethasone	Arm 2: Active comparator
1	Dexamethasone	Arm 1: study medication
1	Ondansetron	Arm 1: study medication
2	Ondansetron	Arm 2: Active comparator

Primary Outcome Measures

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

Secondary Outcome Measures

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