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

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-Induced Nausea and Vomiting

Intervention: GW679769 (Drug); Dexamethasone (Drug); Ondansetron Hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Clinical Trials Call Center, Buenos Aires 1437, Argentina

GSK Clinical Trials Call Center, Buenos Aires C1405CBA, Argentina

GSK Clinical Trials Call Center, Salzburg A-5020, Austria

GSK Clinical Trials Call Center, Vienna A-1090, Austria

GSK Clinical Trials Call Center, Vienna A-1130, Austria

GSK Clinical Trials Call Center, Osijek 31000, Croatia

GSK Clinical Trials Call Center, Prague 180 00, Czech Republic

GSK Clinical Trials Call Center, Ostrava 708 52, Czech Republic

GSK Clinical Trials Call Center, Hradec Kralove 500 05, Czech Republic

GSK Clinical Trials Call Center, Athens 115 22, Greece

GSK Clinical Trials Call Center, Thessaloniki 564 29, Greece

GSK Clinical Trials Call Center, Athens 124 61, Greece

GSK Clinical Trials Call Center, Matrahaza 3233, Hungary

GSK Clinical Trials Call Center, Budapest 1529, Hungary

GSK Clinical Trials Call Center, Budapest 1122, Hungary

GSK Clinical Trials Call Center, Dublin 8, Ireland

GSK Clinical Trials Call Center, Dublin 4, Ireland

GSK Clinical Trials Call Center, Dublin 7, Ireland

GSK Clinical Trials Call Center, Dublin 9, Ireland

GSK Clinical Trials Call Center, Merida 97500, Mexico

GSK Clinical Trials Call Center, Durango 34000, Mexico

GSK Clinical Trials Call Center, Lahore, Pakistan

GSK Clinical Trials Call Center, Olsztyn 10-228, Poland

GSK Clinical Trials Call Center, Kielce 25-640, Poland

GSK Clinical Trials Call Center, Poznan 61-848, Poland

GSK Clinical Trials Call Center, Opole 45-060, Poland

GSK Clinical Trials Call Center, Szczecin 71-730, Poland

GSK Clinical Trials Call Center, Lisbon 1070, Portugal

GSK Clinical Trials Call Center, Lisbon 1069-166, Portugal

GSK Clinical Trials Call Center, Moscow 117 837, Russian Federation

GSK Clinical Trials Call Center, Moscow 115 478, Russian Federation

GSK Clinical Trials Call Center, Moscow 129 301, Russian Federation

GSK Clinical Trials Call Center, Moscow Region 143 423, Russian Federation

GSK Clinical Trials Call Center, Singapore 119074, Singapore

GSK Clinical Trials Call Center, Singapore 169610, Singapore

GSK Clinical Trials Call Center, Bratislava 833 10, Slovakia

GSK Clinical Trials Call Center, Zilina 012 07, Slovakia

GSK Clinical Trials Call Center, Poprad 058 01, Slovakia

GSK Clinical Trials Call Center, Madrid 28040, Spain

GSK Clinical Trials Call Center, Pontevedra 36002, Spain

GSK Clinical Trials Call Center, Madrid 28034, Spain

GSK Clinical Trials Call Center, Barcelona 8009, Spain

GSK Clinical Trials Call Center, Valencia 46009, Spain

GSK Clinical Trials Call Center, Taipei 100, Taiwan

GSK Clinical Trials Call Center, Taipei 104, Taiwan

GSK Clinical Trials Call Center, Tainan City 704, Taiwan

GSK Clinical Trials Call Center, Bangkok 10400, Thailand

GSK Clinical Trials Call Center, Chiang Mai 50200, Thailand

GSK Clinical Trials Call Center, Shrewsbury SY3 8XQ, United Kingdom

GSK Clinical Trials Call Center, Nottingham NG5 1PB, United Kingdom

GSK Clinical Trials Call Center, Edinburgh EH4 2XU, United Kingdom

GSK Clinical Trials Call Center, Exeter EX2 5DW, United Kingdom

GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States

GSK Clinical Trials Call Center, Munich, Bayern 81675, Germany

GSK Clinical Trials Call Center, Regensburg, Bayern 93049, Germany

GSK Clinical Trials Call Center, Greenbrae, California 94904, United States

GSK Clinical Trials Call Center, Corona, California 92882, United States

GSK Clinical Trials Call Center, Los Angeles, California 90057, United States

GSK Clinical Trials Call Center, Palm Springs, California 92262, United States

GSK Clinical Trials Call Center, Loma Linda, California 92354, United States

GSK Clinical Trials Call Center, Lakewood, Colorado 80214, United States

GSK Clinical Trials Call Center, Tallght, Dublin 24, Ireland

GSK Clinical Trials Call Center, Chelmsford, Essex CM1 7ET, United Kingdom

GSK Clinical Trials Call Center, Miami, Florida 33161, United States

GSK Clinical Trials Call Center, Ocala, Florida 34474, United States

GSK Clinical Trials Call Center, Boynton Beach, Florida 33435, United States

GSK Clinical Trials Call Center, New Port Richey, Florida 34652, United States

GSK Clinical Trials Call Center, Boynton Beach, Florida 33435, United States

GSK Clinical Trials Call Center, Centralia, Illinois 62801, United States

GSK Clinical Trials Call Center, Joliet, Illinois 60435, United States

GSK Clinical Trials Call Center, Park Ridge, Illinois 60068, United States

GSK Clinical Trials Call Center, Skokie, Illinois 60076, United States

GSK Clinical Trials Call Center, Evansville, Indiana 47713, United States

GSK Clinical Trials Call Center, New Albany, Indiana 47150, United States

GSK Clinical Trials Call Center, Muncie, Indiana 47303, United States

GSK Clinical Trials Call Center, Hutchinson, Kansas 67502, United States

GSK Clinical Trials Call Center, Alexandria, Louisiana 71301, United States

GSK Clinical Trials Call Center, Baton Rouge, Louisiana 70809, United States

GSK Clinical Trials Call Center, Bethesda, Maryland 20817, United States

GSK Clinical Trials Call Center, Worcester, Massachusetts 01605, United States

GSK Clinical Trials Call Center, Boston, Massachusetts 02118, United States

GSK Clinical Trials Call Center, Bay City, Michigan 48706, United States

GSK Clinical Trials Call Center, Tupelo, Mississippi 38801, United States

GSK Clinical Trials Call Center, Jefferson City, Missouri 65109, United States

GSK Clinical Trials Call Center, St. Louis, Missouri 63141, United States

GSK Clinical Trials Call Center, Rolla, Missouri 65401, United States

GSK Clinical Trials Call Center, Sparta, New Jersey 07871, United States

GSK Clinical Trials Call Center, Rochester, New York 14621, United States

GSK Clinical Trials Call Center, Staten Island, New York 10305, United States

GSK Clinical Trials Call Center, Bronx, New York 10467, United States

GSK Clinical Trials Call Center, Essen, Nordrhein-Westfalen 45122, Germany

GSK Clinical Trials Call Center, Bismark, North Dakota 85803, United States

GSK Clinical Trials Call Center, Canton, Ohio 44718, United States

GSK Clinical Trials Call Center, Akron, Ohio 44304, United States

GSK Clinical Trials Call Center, Sumter, South Carolina 29150, United States

GSK Clinical Trials Call Center, Knoxville, Tennessee 37920, United States

GSK Clinical Trials Call Center, Houston, Texas 77024, United States

GSK Clinical Trials Call Center, Corpus Christi, Texas 78463, United States

GSK Clinical Trials Call Center, Dallas, Texas 75237, United States

GSK Clinical Trials Call Center, Tyler, Texas 75708, United States

GSK Clinical Trials Call Center, Ogden, Utah 84403, United States

GSK Clinical Trials Call Center, West Point, Utah 84341, United States

GSK Clinical Trials Call Center, Burlington, Vermont 05401, United States

GSK Clinical Trials Call Center, Richmond, Virginia 23230, United States

GSK Clinical Trials Call Center, Abingdon, Virginia 24211, United States

GSK Clinical Trials Call Center, Cardiff, Wales CF14 2TL, United Kingdom

GSK Clinical Trials Call Center, Tacoma, Washington 98431, United States

GSK Clinical Trials Call Center, Everett, Washington 98201, United States

GSK Clinical Trials Call Center, Tacoma, Washington 98405, United States

GSK Clinical Trials Call Center, Rhinelander, Wisconsin 54501, United States

Additional Information

Starting date: December 2004
Last updated: February 15, 2008

Page last updated: June 20, 2008

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