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

NCT ID: NCT00104403

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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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 and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Ondansetron Hydrochloride

Intervention Type DRUG

Other Intervention Names

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GW679769 Dexamethasone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Corona, California, United States

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Greenbrae, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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Lakewood, Colorado, United States

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Boynton Beach, Florida, United States

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Hudson, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Centralia, Illinois, United States

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Park Ridge, Illinois, United States

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Skokie, Illinois, United States

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Evansville, Indiana, United States

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Muncie, Indiana, United States

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New Albany, Indiana, United States

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Hutchinson, Kansas, United States

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Alexandria, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Bethesda, Maryland, United States

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Worcester, Massachusetts, United States

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Bay City, Michigan, United States

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Tupelo, Mississippi, United States

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Jefferson City, Missouri, United States

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Rolla, Missouri, United States

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St Louis, Missouri, United States

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Sparta, New Jersey, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Bismarck, North Dakota, United States

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Akron, Ohio, United States

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Canton, Ohio, United States

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Sumter, South Carolina, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Ogden, Utah, United States

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West Point, Utah, United States

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Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Rhinelander, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Kitchener, Ontario, Canada

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Oshawa, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Greenfield Park, Quebec, Canada

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Québec, Quebec, Canada

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Osijek, , Croatia

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Hradec Králové, , Czechia

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Ostrava - Poruba, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Essen, North Rhine-Westphalia, Germany

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Athens, , Greece

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Haidari, , Greece

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Thessaloniki, , Greece

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Pokfulam, , Hong Kong

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Budapest, , Hungary

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Mátraháza, , Hungary

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Tallaght, Dublin, , Ireland

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Tullamore, , Ireland

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Durango, Durango, Mexico

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Mérida, Yucatán, Mexico

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Karachi, , Pakistan

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Lahore, , Pakistan

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Quezon City, , Philippines

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Taft Avenue, Manila, , Philippines

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Kielce, , Poland

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Olsztyn, , Poland

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Opole, , Poland

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Szczecin, , Poland

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Lisbon, , Portugal

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow Region, , Russia

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Singapore, , Singapore

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Bratislava, , Slovakia

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Žilina, , Slovakia

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Madrid, , Spain

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Marid, , Spain

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Pontevedra, , Spain

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Valencia, , Spain

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Exeter, Devon, United Kingdom

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Chelmsford, Essex, United Kingdom

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Cardiff, Glamorgan, United Kingdom

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Edinburgh, Midlothian, United Kingdom

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Shrewsbury, , United Kingdom

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Countries

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United States Argentina Austria Canada Chile Croatia Czechia Germany Greece Hong Kong Hungary Ireland Mexico Pakistan Philippines Poland Portugal Russia Singapore Slovakia Spain Taiwan Thailand United Kingdom

References

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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.

Reference Type RESULT
PMID: 19834961 (View on PubMed)

Other Identifiers

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NKV101983

Identifier Type: -

Identifier Source: org_study_id

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