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Completed

NCT Number: NCT00169572

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

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.

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Key information

Conditions

Nausea and Vomiting Chemotherapy-Induced Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Capital Federal, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant

Drug

ondansetron

Drug

GW679769

Drug

Dexamethasone

Drug

Other names: Aprepitant, Ondansetron, GW679769

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

See Detailed Description

Important dates

Study start
2005
First posted
Sep 15, 2005
Registry last updated
May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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