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

NCT00104403 | Completed Phase 2

• 1 other identifier: NKV101983
• Study Type: interventional
• Target: 722
• Locations: 24 countries
• Sites: 113

Brief 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.

Conditions

Nausea and Vomiting, Chemotherapy-Induced; Chemotherapy-Induced Nausea and Vomiting

Keywords

Vomiting; CINV; Emesis; Nausea; Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

GW679769 DRUG

Dexamethasone DRUG

Ondansetron Hydrochloride DRUG

Also known as: GW679769, Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (113)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

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GSK Investigational Site

Corona, California, 92882, United States

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GSK Investigational Site

Greenbrae, California, 94904-2007, United States

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GSK Investigational Site

Loma Linda, California, 92354, United States

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Los Angeles, California, 90057, United States

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Palm Springs, California, 92262, United States

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Lakewood, Colorado, 80215, United States

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Boynton Beach, Florida, 33435, United States

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Hudson, Florida, 34667, United States

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Miami, Florida, 33138, United States

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Ocala, Florida, 34474, United States

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Centralia, Illinois, 62801, United States

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Park Ridge, Illinois, 60068, United States

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Skokie, Illinois, 60076, United States

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Evansville, Indiana, 47713, United States

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Muncie, Indiana, 47303, United States

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New Albany, Indiana, 47150, United States

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Hutchinson, Kansas, 67502, United States

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Alexandria, Louisiana, 71301, United States

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Baton Rouge, Louisiana, 70809, United States

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Bethesda, Maryland, 20817, United States

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Worcester, Massachusetts, 01608, United States

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Bay City, Michigan, 48708, United States

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Tupelo, Mississippi, 38801, United States

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GSK Investigational Site

Jefferson City, Missouri, 65109, United States

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GSK Investigational Site

Rolla, Missouri, 65401, United States

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St Louis, Missouri, 63141, United States

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Sparta, New Jersey, 07871, United States

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Rochester, New York, 14621, United States

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The Bronx, New York, 10467-2490, United States

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Bismarck, North Dakota, 58503, United States

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Akron, Ohio, 44304, United States

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Canton, Ohio, 44718, United States

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Sumter, South Carolina, 29150, United States

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Corpus Christi, Texas, 78463-3069, United States

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Dallas, Texas, 75237, United States

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Houston, Texas, 77024, United States

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Tyler, Texas, 75708, United States

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Ogden, Utah, 84403, United States

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West Point, Utah, 84341, United States

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Burlington, Vermont, 05401, United States

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Abingdon, Virginia, 24211, United States

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Richmond, Virginia, 23230, United States

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Everett, Washington, 98201, United States

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Tacoma, Washington, 98405, United States

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Tacoma, Washington, 98431, United States

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Rhinelander, Wisconsin, 54501, United States

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Capital Federal, Buenos Aires, C1437JCP, Argentina

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Buenos Aires, C1405CBA, Argentina

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Salzburg, A-5020, Austria

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Vienna, A-1090, Austria

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Vienna, A-1130, Austria

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Kitchener, Ontario, N2G 1G3, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Charlottetown, Prince Edward Island, C1A 8T5, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Santiago, Región Metro de Santiago, 7500921, Chile

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Santiago, Región Metro de Santiago, 8380456, Chile

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Santiago, Región Metro de Santiago, Chile

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Osijek, Croatia

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Hradec Králové, 500 05, Czechia

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GSK Investigational Site

Ostrava - Poruba, 708 52, Czechia

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Prague, 100 00, Czechia

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Prague, 154 00, Czechia

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Prague, 180 00, Czechia

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Munich, Bavaria, 81675, Germany

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Regensburg, Bavaria, 93049, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Athens, 115 22, Greece

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Haidari, 124 61, Greece

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Thessaloniki, 564 29, Greece

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Pokfulam, Hong Kong

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Budapest, 1529, Hungary

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Mátraháza, 3233, Hungary

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Dublin, 4, Ireland

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Dublin, 7, Ireland

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Dublin, 8, Ireland

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Dublin, 9, Ireland

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Tallaght, Dublin, 24, Ireland

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Tullamore, Ireland

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GSK Investigational Site

Durango, Durango, 34000, Mexico

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Mérida, Yucatán, 97500, Mexico

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Karachi, 54000, Pakistan

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Lahore, Pakistan

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Quezon City, 1101, Philippines

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Taft Avenue, Manila, 1700, Philippines

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Kielce, 25-640, Poland

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Olsztyn, 10-228, Poland

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Opole, 45-060, Poland

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Szczecin, 71-730, Poland

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Lisbon, 1070, Portugal

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Moscow, 115 478, Russia

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GSK Investigational Site

Moscow, 117997, Russia

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GSK Investigational Site

Moscow, 129301, Russia

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GSK Investigational Site

Moscow Region, 143 423, Russia

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Singapore, 169610, Singapore

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Bratislava, 833 10, Slovakia

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Žilina, 010 01, Slovakia

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Madrid, 28034, Spain

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GSK Investigational Site

Marid, 28040, Spain

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GSK Investigational Site

Pontevedra, 36071, Spain

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Valencia, 46009, Spain

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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GSK Investigational Site

Taipei, 104, Taiwan

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GSK Investigational Site

Bangkok, 10400, Thailand

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GSK Investigational Site

Chiang Mai, 50200, Thailand

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GSK Investigational Site

Exeter, Devon, EX2 5DW, United Kingdom

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GSK Investigational Site

Chelmsford, Essex, CM1 7ET, United Kingdom

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GSK Investigational Site

Cardiff, Glamorgan, CF14 2TL, United Kingdom

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Edinburgh, Midlothian, EH4 2XU, United Kingdom

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GSK Investigational Site

Shrewsbury, SY3 8XQ, United Kingdom

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Related Publications (1)

• Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630.

  PMID: 19834961 RESULT

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

casopitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2005
• First Posted: March 1, 2005
• Study Start: December 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

CZ (5); US (47); CR (1); ME (2); PH (2); SG (1); AU (3); ES (4); IE (6); CL (3); PA (2); PT (1); HK (1); TW (3); GB (5); AR (2); CA (5); RU (4); PL (4); SL (2); GR (3); TH (2); HU (2); DE (3)