Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | December 2004 |
End Date: | January 2006 |
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
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.
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.
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
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:
- 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.
We found this trial at
47
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