Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104403
• Other study ID #: NKV101983
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2005
• Last updated: April 15, 2015
• Start date: December 2004
• Est. completion date: January 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• 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 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GW679769

• Dexamethasone

• Ondansetron Hydrochloride

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
Canada	GSK Investigational Site	Charlottetown	Prince Edward Island
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Québec	Quebec
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Croatia	GSK Investigational Site	Osijek
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Ostrava - Poruba
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 8
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Regensburg	Bayern
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Haidari
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Pokfulam
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Mátraháza
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Tallaght, Dublin
Ireland	GSK Investigational Site	Tullamore
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Merida	Yucatán
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Lahore
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Taft Avenue, Manila
Poland	GSK Investigational Site	Kielce
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Opole
Poland	GSK Investigational Site	Szczecin
Portugal	GSK Investigational Site	Lisboa
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow Region
Singapore	GSK Investigational Site	Singapore
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Zilina
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Pontevedra
Spain	GSK Investigational Site	Valencia
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiang Mai
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Chelmsford	Essex
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Exeter	Devon
United Kingdom	GSK Investigational Site	Shrewsbury
United States	GSK Investigational Site	Abingdon	Virginia
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bay City	Michigan
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Burlington	Vermont
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Centralia	Illinois
United States	GSK Investigational Site	Corona	California
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Everett	Washington
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Hudson	Florida
United States	GSK Investigational Site	Hutchinson	Kansas
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Loma Linda	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Muncie	Indiana
United States	GSK Investigational Site	New Albany	Indiana
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Palm Springs	California
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Rhinelander	Wisconsin
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Sparta	New Jersey
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Sumter	South Carolina
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tupelo	Mississippi
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	West Point	Utah
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Canada,  Chile,  Croatia,  Czech Republic,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Mexico,  Pakistan,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Spain,  Taiwan,  Thailand,  United Kingdom, 

References & Publications (1)

Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and — View Citation

Outcome

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