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

NCT00619359 | Completed Phase 3 Results

• 3 other identifiers: 0517-017MK0517-0172007_594
• Study Type: interventional
• Target: 2,322
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting (CINV)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

• No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)

  Overall (the 120 hours following initiation of cisplatin chemotherapy)

Study Arms (2)

1

EXPERIMENTAL

Arm 1: study medication

Drug: Comparator: fosaprepitant dimeglumine; Drug: Dexamethasone; Drug: Ondansetron

2

ACTIVE COMPARATOR

Arm 2: Active comparator

Drug: Comparator: Aprepitant; Drug: Dexamethasone; Drug: Ondansetron

Interventions

Comparator: fosaprepitant dimeglumine DRUG

single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.

1

Comparator: Aprepitant DRUG

Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

2

Dexamethasone DRUG

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.

1

Ondansetron DRUG

single IV dose of 32 mg of ondansetron on Day 1.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.

  PMID: 21383291 RESULT

MeSH Terms

Conditions

Vomiting

Interventions

Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 21, 2017
• Results First Posted: February 12, 2010

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share