Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

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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 vomiting.

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 Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

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.