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

NCT ID: NCT00169572

Last Updated: 2010-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nausea and Vomiting Chemotherapy-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aprepitant

Intervention Type DRUG

Ondansetron

Intervention Type DRUG

GW679769

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Aprepitant Ondansetron GW679769

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

Site Status

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Buenos Aires, , Argentina

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Zagreb, , Croatia

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Hradec Králové, , Czechia

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Ostrava - Poruba, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Shatin, N.T., , Hong Kong

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Budapest, , Hungary

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Székesfehérvár, , Hungary

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Benevento, Campania, Italy

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Napoli, Campania, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Casalpusterlengo (LO), Lombardy, Italy

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Sassari, Sardinia, Italy

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Pisa, Tuscany, Italy

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Perugia, Umbria, Italy

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Durango, Durango, Mexico

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Mérida, Yucatán, Mexico

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Karachi, , Pakistan

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Lahore, , Pakistan

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Callao, Provincia Constitucional del Callao, Peru

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Quezon City, , Philippines

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Taft Avenue, Manila, , Philippines

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Bydogoszcz, , Poland

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Krakow, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Bucharest, , Romania

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Singapore, , Singapore

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Košice, , Slovakia

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Nitra, , Slovakia

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Taipei, , Taiwan

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Taipei, , Taiwan

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Tao Yuan County, , Taiwan

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Countries

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Argentina Austria Belgium Chile Croatia Czechia Hong Kong Hungary Italy Mexico Netherlands Pakistan Peru Philippines Poland Romania Singapore Slovakia Taiwan

Other Identifiers

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NKV20001

Identifier Type: -

Identifier Source: org_study_id

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