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
sites
Hudson, Florida 34667
649
mi
from 43215
Hudson, FL
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Abingdon, Virginia 24210
231
mi
from 43215
Abingdon, VA
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Akron, Ohio 44313
111
mi
from 43215
Akron, OH
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Alexandria, Louisiana 71301
797
mi
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Alexandria, LA
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Baton Rouge, Louisiana 70809
801
mi
from 43215
Baton Rouge, LA
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Bay City, Michigan 48706
254
mi
from 43215
Bay City, MI
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Bethesda, Maryland 20892
322
mi
from 43215
Bethesda, MD
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Birmingham, Alabama 35249
493
mi
from 43215
Birmingham, AL
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Bismarck, North Dakota 58501
1006
mi
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Bismarck, ND
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Boynton Beach, Florida 33472
941
mi
from 43215
Boynton Beach, FL
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Bronx, New York 10461
486
mi
from 43215
Bronx, NY
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Burlington, Vermont 05401
590
mi
from 43215
Burlington, VT
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Canton, Ohio 44708
101
mi
from 43215
Canton, OH
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Capital Federal, Buenos Aires
5386
mi
from 43215
Capital Federal,
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Centralia, Illinois 62801
341
mi
from 43215
Centralia, IL
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Corona, California 92882
1941
mi
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Corona, CA
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Corpus Christi, Texas 78405
1177
mi
from 43215
Corpus Christi, TX
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Dallas, Texas 75230
905
mi
from 43215
Dallas, TX
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Evansville, Indiana 47714
278
mi
from 43215
Evansville, IN
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Everett, Washington 98201
2000
mi
from 43215
Everett, WA
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Greenbrae, California 94904
2109
mi
from 43215
Greenbrae, CA
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Hutchinson, Kansas 67502
809
mi
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Hutchinson, KS
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Jefferson City, Missouri 65109
498
mi
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Jefferson City, MO
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Lakewood, Colorado 80228
1171
mi
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Lakewood, CO
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Loma Linda, California 92357
1919
mi
from 43215
Loma Linda, CA
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Los Angeles, California 90025
1983
mi
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Los Angeles, CA
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Miami, Florida 33136
992
mi
from 43215
Miami, FL
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Muncie, Indiana 47304
125
mi
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Muncie, IN
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New Albany, Indiana 47150
189
mi
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New Albany, IN
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Ocala, Florida 34471
748
mi
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Ocala, FL
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Ogden, Utah 84403
1514
mi
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Ogden, UT
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Palm Springs, California 92262
1888
mi
from 43215
Palm Springs, CA
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Park Ridge, Illinois 60068
288
mi
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Park Ridge, IL
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Rhinelander, Wisconsin 54501
507
mi
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Rhinelander, WI
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Richmond, Virginia 23298
344
mi
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Richmond, VA
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Rochester, New York 14642
354
mi
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Rochester, NY
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Rolla, Missouri 65401
489
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Rolla, MO
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Skokie, Illinois 60076
283
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Skokie, IL
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Sparta, New Jersey 07871
446
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Sparta, NJ
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St. Louis, Missouri 63110
397
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St. Louis, MO
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Sumter, South Carolina 29150
443
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Sumter, SC
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Tacoma, Washington 98405
2013
mi
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Tacoma, WA
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Tupelo, Mississippi 38801
503
mi
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Tupelo, MS
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Tyler, Texas 75702
862
mi
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Tyler, TX
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West Point, Utah 84341
1421
mi
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West Point, UT
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Worcester, Massachusetts 01655
607
mi
from 43215
Worcester, MA
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