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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW679769
Dexamethasone
Ondansetron Hydrochloride
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring Vomiting, CINV, Emesis, Nausea, Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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 Measures

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.

Full Information

First Posted
February 28, 2005
Last Updated
April 15, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00104403
Brief Title
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Chemotherapy-Induced, Chemotherapy-Induced Nausea and Vomiting
Keywords
Vomiting, CINV, Emesis, Nausea, Chemotherapy-Induced Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
722 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW679769
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Ondansetron Hydrochloride
Other Intervention Name(s)
GW679769, Dexamethasone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Investigational Site
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
GSK Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
GSK Investigational Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
GSK Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
GSK Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
GSK Investigational Site
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
GSK Investigational Site
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
GSK Investigational Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
GSK Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
GSK Investigational Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
GSK Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
GSK Investigational Site
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
GSK Investigational Site
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
GSK Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
GSK Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
GSK Investigational Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
GSK Investigational Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
GSK Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
GSK Investigational Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
GSK Investigational Site
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58503
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
GSK Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
GSK Investigational Site
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
GSK Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78463-3069
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
GSK Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
GSK Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
GSK Investigational Site
City
West Point
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
GSK Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
GSK Investigational Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
GSK Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
GSK Investigational Site
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1405CBA
Country
Argentina
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
GSK Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
GSK Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
Country
Chile
Facility Name
GSK Investigational Site
City
Osijek
Country
Croatia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
154 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
GSK Investigational Site
City
Haidari
ZIP/Postal Code
124 61
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Mátraháza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
GSK Investigational Site
City
Tallaght, Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
GSK Investigational Site
City
Tullamore
Country
Ireland
Facility Name
GSK Investigational Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97500
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
GSK Investigational Site
City
Karachi
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lahore
Country
Pakistan
Facility Name
GSK Investigational Site
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
GSK Investigational Site
City
Taft Avenue, Manila
ZIP/Postal Code
1700
Country
Philippines
Facility Name
GSK Investigational Site
City
Kielce
ZIP/Postal Code
25-640
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
GSK Investigational Site
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1070
Country
Portugal
Facility Name
GSK Investigational Site
City
Moscow Region
ZIP/Postal Code
143 423
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
GSK Investigational Site
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
GSK Investigational Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
GSK Investigational Site
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19834961
Citation
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.
Results Reference
result

Learn more about this trial

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

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