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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Nausea and Vomiting

Chemotherapy-Induced

Treatments

Drug: GW679769

Drug: Dexamethasone

Drug: Ondansetron

Drug: Aprepitant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00169572

NKV20001

Details and patient eligibility

About

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.

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.