Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

April 15, 2015 updated by: GlaxoSmithKline

A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea

This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1405CBA
        • GSK Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1437JCP
        • GSK Investigational Site
  • Austria
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Vienna, Austria, A-1090
        • GSK Investigational Site
      • Vienna, Austria, A-1130
        • GSK Investigational Site
  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1J 1Z4
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 8380456
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500921
        • GSK Investigational Site
  • Croatia
      • Osijek, Croatia
        • GSK Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • GSK Investigational Site
      • Ostrava - Poruba, Czech Republic, 708 52
        • GSK Investigational Site
      • Praha 10, Czech Republic, 100 00
        • GSK Investigational Site
      • Praha 5, Czech Republic, 154 00
        • GSK Investigational Site
      • Praha 8, Czech Republic, 180 00
        • GSK Investigational Site
  • Germany
    • Bayern
      • Muenchen, Bayern, Germany, 81675
        • GSK Investigational Site
      • Regensburg, Bayern, Germany, 93049
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 22
        • GSK Investigational Site
      • Haidari, Greece, 124 61
        • GSK Investigational Site
      • Thessaloniki, Greece, 564 29
        • GSK Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Investigational Site
      • Mátraháza, Hungary, 3233
        • GSK Investigational Site
  • Ireland
      • Dublin, Ireland, 8
        • GSK Investigational Site
      • Dublin, Ireland, 9
        • GSK Investigational Site
      • Dublin, Ireland, 4
        • GSK Investigational Site
      • Dublin, Ireland, 7
        • GSK Investigational Site
      • Tallaght, Dublin, Ireland, 24
        • GSK Investigational Site
      • Tullamore, Ireland
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • GSK Investigational Site
    • Yucatán
      • Merida, Yucatán, Mexico, 97500
        • GSK Investigational Site
  • Pakistan
      • Karachi, Pakistan, 54000
        • GSK Investigational Site
      • Lahore, Pakistan
        • GSK Investigational Site
  • Philippines
      • Quezon City, Philippines, 1101
        • GSK Investigational Site
      • Taft Avenue, Manila, Philippines, 1700
        • GSK Investigational Site
  • Poland
      • Kielce, Poland, 25-640
        • GSK Investigational Site
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
      • Opole, Poland, 45-060
        • GSK Investigational Site
      • Szczecin, Poland, 71-730
        • GSK Investigational Site
  • Portugal
      • Lisboa, Portugal, 1070
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • GSK Investigational Site
      • Moscow, Russian Federation, 115 478
        • GSK Investigational Site
      • Moscow, Russian Federation, 129301
        • GSK Investigational Site
      • Moscow Region, Russian Federation, 143 423
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 169610
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • GSK Investigational Site
      • Zilina, Slovakia, 010 01
        • GSK Investigational Site
  • Spain
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Pontevedra, Spain, 36071
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site
  • Taiwan
      • Tainan, Taiwan, 704
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 104
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Chiang Mai, Thailand, 50200
        • GSK Investigational Site
  • United Kingdom
      • Shrewsbury, United Kingdom, SY3 8XQ
        • GSK Investigational Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • GSK Investigational Site
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • GSK Investigational Site
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF14 2TL
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
    • California
      • Corona, California, United States, 92882
        • GSK Investigational Site
      • Greenbrae, California, United States, 94904-2007
        • GSK Investigational Site
      • Loma Linda, California, United States, 92354
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • GSK Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • GSK Investigational Site
      • Hudson, Florida, United States, 34667
        • GSK Investigational Site
      • Miami, Florida, United States, 33138
        • GSK Investigational Site
      • Ocala, Florida, United States, 34474
        • GSK Investigational Site
    • Illinois
      • Centralia, Illinois, United States, 62801
        • GSK Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • GSK Investigational Site
      • Skokie, Illinois, United States, 60076
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Investigational Site
      • Muncie, Indiana, United States, 47303
        • GSK Investigational Site
      • New Albany, Indiana, United States, 47150
        • GSK Investigational Site
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • GSK Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • GSK Investigational Site
      • Baton Rouge, Louisiana, United States, 70809
        • GSK Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • GSK Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • GSK Investigational Site
    • Michigan
      • Bay City, Michigan, United States, 48708
        • GSK Investigational Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • GSK Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • GSK Investigational Site
      • Rolla, Missouri, United States, 65401
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10467-2490
        • GSK Investigational Site
      • Rochester, New York, United States, 14621
        • GSK Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
      • Canton, Ohio, United States, 44718
        • GSK Investigational Site
    • South Carolina
      • Sumter, South Carolina, United States, 29150
        • GSK Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78463-3069
        • GSK Investigational Site
      • Dallas, Texas, United States, 75237
        • GSK Investigational Site
      • Houston, Texas, United States, 77024
        • GSK Investigational Site
      • Tyler, Texas, United States, 75708
        • GSK Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • GSK Investigational Site
      • West Point, Utah, United States, 84341
        • GSK Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • GSK Investigational Site
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23230
        • GSK Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98431
        • GSK Investigational Site
    • Wisconsin
      • Rhinelander, Wisconsin, United States, 54501
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
  • Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
  • Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.

Exclusion criteria:

  • Not received any investigational product within 30 days of enrollment into the study.
  • Must not be pregnant.
  • Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
  • Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
  • Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
  • Must not have a history of peptic ulcer disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

Secondary Outcome Measures

Outcome Measure
Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

February 28, 2005

First Submitted That Met QC Criteria

February 28, 2005

First Posted (Estimate)

March 1, 2005

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV101983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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