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

Condition(s) targeted: Nausea and Vomiting; Chemotherapy-Induced

Intervention: Aprepitant (Drug); Ondansetron (Drug); GW679769 (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

Secondary outcome: Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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Starting date: January 2005
Last updated: February 15, 2008