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

Chemotherapy-Induced Nausea and Vomiting (CINV) Clinical Trial

— EASE  

Official title:

Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability & Efficacy of a Single Dose of Intravenous MK0517 for Prevention of Chemotherapy-Induced Nausea & Vomiting Associated With Cisplatin Chemo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619359
• Other study ID #: 0517-017
• Secondary ID: MK0517-0172007_5
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2008
• Last updated: February 6, 2015
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2322
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting (CINV)
• Vomiting

Intervention

Drug:
• Comparator: fosaprepitant dimeglumine
single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
• Comparator: Aprepitant
Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
• Dexamethasone
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.
• Dexamethasone
Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
• Ondansetron
single IV dose of 32 mg of ondansetron on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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
Secondary	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)	No