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Phase 2
18 Years
Not Enrolling
Nausea and Vomiting, Chemotherapy-Induced

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Trial Information

See 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 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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



Italy: The Italian Medicines Agency

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Chemotherapy-Induced
  • Nausea
  • Vomiting
  • Emesis
  • Chemotherapy-induced Nausea and Vomiting
  • CINV
  • Nausea
  • Vomiting