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

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea and Vomiting; Chemotherapy-Induced

Intervention: Aprepitant (Drug); Ondansetron (Drug); GW679769 (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: 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.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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.

Locations and Contacts

GSK Clinical Trials Call Center, Buenos Aires 1437, Argentina

GSK Clinical Trials Call Center, Buenos Aires C1405CBA, Argentina

GSK Clinical Trials Call Center, Vienna A-1090, Austria

GSK Clinical Trials Call Center, Salzburg A-5020, Austria

GSK Clinical Trials Call Center, Vienna A-1130, Austria

GSK Clinical Trials Call Center, Edegem 2650, Belgium

GSK Clinical Trials Call Center, Leuven 3000, Belgium

GSK Clinical Trials Call Center, Gent 9000, Belgium

GSK Clinical Trials Call Center, Liege 4000, Belgium

GSK Clinical Trials Call Center, Santiago, Chile

GSK Clinical Trials Call Center, Santiago, Chile

GSK Clinical Trials Call Center, Zagreb 10000, Croatia

GSK Clinical Trials Call Center, Zagreb 10000, Croatia

GSK Clinical Trials Call Center, Ostrava 708 52, Czech Republic

GSK Clinical Trials Call Center, Prague 180 81, Czech Republic

GSK Clinical Trials Call Center, Hradec Kralove 500 05, Czech Republic

GSK Clinical Trials Call Center, Prague 121 00, Czech Republic

GSK Clinical Trials Call Center, Prague 154 00, Czech Republic

GSK Clinical Trials Call Center, Athens 185 47, Greece

GSK Clinical Trials Call Center, Athens 115 22, Greece

GSK Clinical Trials Call Center, Thessaloniki 564 29, Greece

GSK Clinical Trials Call Center, Athens 124 61, Greece

GSK Clinical Trials Call Centre, Shatin, Hong Kong

GSK Clinical Trials Call Center, Matrahaza 3233, Hungary

GSK Clinical Trials Call Center, Budapest 1122, Hungary

GSK Clinical Trials Call Center, Szekesfehervar 8000, Hungary

GSK Clinical Trials Call Center, Gyula 5703, Hungary

GSK Clinical Trials Call Center, Budapest 1529, Hungary

GSK Clinical Trials Call Center, Sassari 07100, Italy

GSK Clinical Trials Call Center, Naples 80131, Italy

GSK Clinical Trials Call Center, Rome 00184, Italy

GSK Clinical Trials Call Center, Rome 00149, Italy

GSK Clinical Trials Call Center, Perugia 06122, Italy

GSK Clinical Trials Call Center, Milan 20133, Italy

GSK Clinical Trials Call Center, Pisa 56124, Italy

GSK Clinical Trials Call Center, Naples 80131, Italy

GSK Clinical Trials Call Center, Benevento 82100, Italy

GSK Clinical Trials Call Center, Avellino 83100, Italy

GSK Clinical Trials Call Center, Lodi 26841, Italy

GSK Clinical Trials Call Center, Acapulco 39670, Mexico

GSK Clinical Trials Call Center, Durango 34000, Mexico

GSK Clinical Trials Call Center, Guadalajara 44280, Mexico

GSK Clinical Trials Call Center, Merida 97500, Mexico

GSK Clinical Trials Call Center, Mexico City 52140, Mexico

GSK Clinical Trials Call Center, Rotterdam 3045 PM, Netherlands

GSK Clinical Trials Call Center, Amsterdam 1066 CX, Netherlands

GSK Clinical Trials Call Center, Amsterdam 1081 HV, Netherlands

GSK Clinical Trials Call Center, Arnhem 6815 AD, Netherlands

GSK Clinical Trials Call Center, Utrecht 3527 CE, Netherlands

GSK Clinical Trials Call Center, Lahore 54700, Pakistan

GSK Clinical Trials Call Center, Karachi 74700, Pakistan

GSK Clinical Trials Call Center, Callao, Peru

GSK Clinical Trials Call Center, Manila 1004, Philippines

GSK Clinical Trials Call Center, Quezon City 0970, Philippines

GSK Clinical Trials Call Center, Krakow 31-115, Poland

GSK Clinical Trials Call Center, Poznan 61-848, Poland

GSK Clinical Trials Call Center, Poznan 60-569, Poland

GSK Clinical Trials Call Center, Poznan 61-866, Poland

GSK Clinical Trials Call Center, Bydgoszcz 85-796, Poland

GSK Clinical Trials Call Center, Lisbon 1150, Portugal

GSK Clinical Trials Call Center, Lisbon 1070, Portugal

GSK Clinical Trials Call Center, Bucharest 22328, Romania

GSK Clinical Trials Call Center, Singapore 119074, Singapore

GSK Clinical Trials Call Center, Singapore 169610, Singapore

GSK Clinical Trials Call Center, Bystrica 975 17, Slovakia

GSK Clinical Trials Call Center, Kosice, Slovakia

GSK Clinical Trials Call Center, Zobor 949 88, Slovakia

GSK Clinical Trials Call Center, Taipei 114, Taiwan

GSK Clinical Trials Call Center, Taipei 112, Taiwan

GSK Clinical Trials Call Center, Taoyuan 333, Taiwan

Additional Information

Starting date: January 2005
Last updated: February 15, 2008

Page last updated: June 20, 2008

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