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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
722

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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