Last updated: 11/04/2018 09:47:34
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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, When Administered as 50 mg, 100 mg, and 150 mg Oral Tablets in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants who achieved a complete response, 0-120 hours (h)
Timeframe: Up to 120 h
Number of participants experiencing significant nausea during the 120 h
Timeframe: Up to 120 h
Secondary outcomes:
Number of participants who achieved a complete response during the acute (0–24 h) and delayed (24–120 h)
Timeframe: Up to 120 h
Number of participants who achieved complete protection during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with significant nausea during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants who received rescue medication during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with Time to emesis and Time to first rescue medication
Timeframe: Up to Day 10
Number of participants with total control during 0–120 h
Timeframe: Up to 120 h
Number of participants with vomiting during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with nausea during 0–120 h
Timeframe: Up to 120 h
Number of participants with Clinically significant change from Baseline in electrocardiogram (ECG) values
Timeframe: Baseline (Day 1) and up to Day 30
Mean systolic and diastolic blood pressure (SBP and DBP) over period
Timeframe: Up to Day 30 and Day 1 of Each Subsequent Cycle
Mean heart rate over period
Timeframe: Up to Day 30 and Day 1 of each Subsequent Cycle
Mean respiration rate over period
Timeframe: Up to Day 30
Number of participants with Hematological parameters outside the reference range
Timeframe: Up to Day 30
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: AEs and SAEs were collected approximately up to 4 cycles (4 months)
Number of participants with response to Functional Living Index - Emesis (FLIE) questionnaire over 0-120 h
Timeframe: Day 1 and Day 6 – 10 Visit
Number of participants with satisfaction response with respect to the control of Chemotherapy-induced nausea and vomiting (CINV)
Timeframe: Up to Day 30
Interventions:
Drug: GW679769
Drug: Dexamethasone
Drug: Ondansetron Hydrochloride
Enrollment:
723
Observational study model:
Not applicable
Primary completion date:
2006-12-01
Time perspective:
Not applicable
Clinical publications:
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.
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;115(24):5807-16.
Medical condition
Chemotherapy-Induced Nausea and Vomiting
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
December 2004 to January 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Not received any investigational product within 30 days of enrollment into the study.
- Must not be pregnant.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
New Albany, Indiana, United States, 47150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bay City, Michigan, United States, 48708
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, California, United States, 92262
Status
Study Complete
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Status
Study Complete
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Centralia, Illinois, United States, 62801
Status
Study Complete
Location
GSK Investigational Site
Exeter, Devon, United Kingdom, EX2 5DW
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
Status
Study Complete
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Study Complete
Location
GSK Investigational Site
Miami, Florida, United States, 33138
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Corona, California, United States, 92882
Status
Study Complete
Location
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF14 2TL
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
West Point, Utah, United States, 84341
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1G3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80215
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23230
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
Status
Study Complete
Location
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
Status
Study Complete
Location
GSK Investigational Site
Sparta, New Jersey, United States, 07871
Status
Study Complete
Location
GSK Investigational Site
Bismarck, North Dakota, United States, 58503
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tyler, Texas, United States, 75708
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1405CBA
Status
Study Complete
Location
GSK Investigational Site
Taft Avenue, Manila, Philippines, 1700
Status
Study Complete
Location
GSK Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Joliet, Illinois, United States, 60435
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78463-3069
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1437JCP
Status
Study Complete
Location
GSK Investigational Site
Rhinelander, Wisconsin, United States, 54501
Status
Study Complete
Location
GSK Investigational Site
Staten Island, New York, United States, 10305
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bronx, New York, United States, 10467-2490
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98431
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Abingdon, Virginia, United States, 24211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burlington, Vermont, United States, 05401
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Status
Study Complete
Location
GSK Investigational Site
Hudson, Florida, United States, 34667
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14621
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montreal, Québec, Canada, H2L 4M1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Hutchinson, Kansas, United States, 67502
Status
Study Complete
Location
GSK Investigational Site
Skokie, Illinois, United States, 60076
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, Texas, United States, 77024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20817
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-12-01
Actual study completion date
2006-12-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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