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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:December 2004
End Date:January 2006

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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.

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

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.
We found this trial at
47
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Skokie, Illinois 60076
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Abingdon, Virginia 24210
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Akron, Ohio 44313
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Alexandria, Louisiana 71301
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Baton Rouge, Louisiana 70809
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Bay City, Michigan 48706
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Bethesda, Maryland 20892
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Birmingham, Alabama 35249
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Bismarck, North Dakota 58501
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Boynton Beach, Florida 33472
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Bronx, New York 10461
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Burlington, Vermont 05401
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Canton, Ohio 44708
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Capital Federal, Buenos Aires
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Centralia, Illinois 62801
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Centralia, IL
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Corona, California 92882
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Corona, CA
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Corpus Christi, Texas 78405
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Dallas, Texas 75230
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Evansville, Indiana 47714
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Everett, Washington 98201
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Greenbrae, California 94904
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Houston, Texas 77030
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Hudson, Florida 34667
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Hutchinson, Kansas 67502
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Jefferson City, Missouri 65109
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Lakewood, Colorado 80228
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Loma Linda, California 92357
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Los Angeles, California 90025
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Miami, Florida 33136
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Muncie, Indiana 47304
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New Albany, Indiana 47150
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Ocala, Florida 34471
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Ogden, Utah 84403
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Palm Springs, California 92262
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Park Ridge, Illinois 60068
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Rhinelander, Wisconsin 54501
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Richmond, Virginia 23298
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Rochester, New York 14642
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Rolla, Missouri 65401
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Sparta, New Jersey 07871
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St. Louis, Missouri 63110
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Sumter, South Carolina 29150
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Tacoma, Washington 98405
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Tupelo, Mississippi 38801
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Tyler, Texas 75702
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West Point, Utah 84341
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Worcester, Massachusetts 01655
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