Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

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

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

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

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

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.

Official title: 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

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

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

Secondary outcome: Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.

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 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.

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Starting date: December 2004
Last updated: February 15, 2008