Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00619359

Purpose

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.

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting (CINV)	Drug: fosaprepitant dimeglumine Drug: Aprepitant Drug: Dexamethasone Drug: Ondansetron	Phase III

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Aprepitant Fosaprepitant dimeglumine Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

A complete response (no vomiting and no use of rescue therapy) overall (in the 120 hours following initiation of cisplatin). [ Time Frame: in the 120 hours following initiation of cisplatin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A complete response (no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of cisplatin). [ Time Frame: 25 to 120 hours following initiation of cisplatin ] [ Designated as safety issue: No ]

Estimated Enrollment:	2292
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: study medication	Drug: fosaprepitant dimeglumine single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1 Drug: Dexamethasone Arm 1: oral dose of 8 mg of dexamethasone on Day 2 and 16 mg on Days 3-4, Arm 2: oral dose of 8 mg of dexamethasone on Days 2-4 Drug: Ondansetron single IV dose of 32 mg of ondansetron on Day 1
2: Active Comparator Arm 2: Active comparator	Drug: Aprepitant Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3). Drug: Dexamethasone Arm 1: oral dose of 8 mg of dexamethasone on Day 2 and 16 mg on Days 3-4, Arm 2: oral dose of 8 mg of dexamethasone on Days 2-4 Drug: Ondansetron single IV dose of 32 mg of ondansetron on Day 1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619359

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 40 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_594, MK0517-017
Study First Received:	January 28, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00619359 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Antiemetics
Hormones
Signs and Symptoms
Cisplatin
Antipruritics

Nausea
Ondansetron
Dexamethasone acetate
Aprepitant
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Serotonin
Anti-Anxiety Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Signs and Symptoms
Serotonin Antagonists
Therapeutic Uses

Antipruritics
Ondansetron
Dermatologic Agents
Dexamethasone acetate
Aprepitant
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 07, 2009