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

Nausea and Vomiting Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169572
• Other study ID #: NKV20001
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: May 6, 2010
• Start date: February 2005

Study information

• Verified date: May 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chemotherapy-Induced
• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant

• Ondansetron

• GW679769

• Dexamethasone

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liege
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Croatia	GSK Investigational Site	Zagreb
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Ostrava - Poruba
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 8
Hong Kong	GSK Investigational Site	Shatin, N.T.
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Székesfehérvár
Italy	GSK Investigational Site	Benevento	Campania
Italy	GSK Investigational Site	Casalpusterlengo (LO)	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sassari	Sardegna
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Merida	Yucatán
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Utrecht
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Lahore
Peru	GSK Investigational Site	Callao
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Taft Avenue, Manila
Poland	GSK Investigational Site	Bydogoszcz
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Romania	GSK Investigational Site	Bucuresti
Singapore	GSK Investigational Site	Singapore
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Nitra
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Tao Yuan County

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Secondary	Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.