Status:
COMPLETED
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nausea and Vomiting
Chemotherapy-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vo...
Detailed Description
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in C...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumour 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 enrolment 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.
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00169572
Start Date
February 1 2005
Last Update
May 10 2010
Active Locations (51)
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1
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1437JCP
2
GSK Investigational Site
Buenos Aires, Argentina, C1405CBA
3
GSK Investigational Site
Salzburg, Austria, A-5020
4
GSK Investigational Site
Vienna, Austria, A-1090