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
18 Years
N/A
Both
Nausea and Vomiting, Chemotherapy-Induced, Chemotherapy-Induced Nausea and Vomiting
Trial Information
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
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
NKV101983
NCT ID:
NCT00104403
Start Date:
December 2004
Completion Date:
Related Keywords:
- Nausea and Vomiting, Chemotherapy-Induced
- Chemotherapy-Induced Nausea and Vomiting
- Vomiting
- CINV
- Emesis
- Nausea
- Chemotherapy-Induced Nausea and Vomiting
- Nausea
- Vomiting
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Indianapolis, Indiana 46260 |
| GSK Investigational Site | New Orleans, Louisiana 70112 |
| GSK Investigational Site | Springfield, Massachusetts 01107 |
| GSK Investigational Site | St. Louis, Missouri 63141 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Green Bay, Wisconsin 54301 |
| GSK Investigational Site | Park Ridge, Illinois 60068 |
| GSK Investigational Site | Baltimore, Maryland 21201 |
| GSK Investigational Site | Royal Oak, Michigan 48073 |
| GSK Investigational Site | Fargo, North Dakota 58103 |
| GSK Investigational Site | Columbia, South Carolina 29210 |
| GSK Investigational Site | Salem, Virginia 24153 |
| GSK Investigational Site | New York, New York 10021 |
| GSK Investigational Site | Birmingham, Alabama 35209 |
| GSK Investigational Site | Aurora, Colorado 80012 |
| GSK Investigational Site | Kansas City, Kansas 66160 |
| GSK Investigational Site | Hattiesburg, Mississippi 39401 |
| GSK Investigational Site | Edison, New Jersey 08837 |
| GSK Investigational Site | Salt Lake City, Utah 84107 |
| GSK Investigational Site | South Burlington, Vermont 05403 |
| GSK Investigational Site | Seattle, Washington 98133 |
