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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Chemotherapy-Induced, Chemotherapy-Induced Nausea and Vomiting

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Trial Information

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


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

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 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Based on 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

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

NKV101983

NCT ID:

NCT00104403

Start Date:

December 2004

Completion Date:

Related Keywords:

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

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteFargo, North Dakota  58103
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSouth Burlington, Vermont  05403
GSK Investigational SiteSeattle, Washington  98133