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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00062686 |
Purpose
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: GW572016 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| GSK Investigational Site | |
| Santa Barbara, California, United States, 93105 | |
| GSK Investigational Site | |
| Duarte, California, United States, 91010 | |
| GSK Investigational Site | |
| Redondo Beach, California, United States, 90277 | |
| GSK Investigational Site | |
| Vista, California, United States, 92083 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92103 | |
| GSK Investigational Site | |
| Fresno, California, United States, 93710 | |
| GSK Investigational Site | |
| Pomona, California, United States, 91767 | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90813 | |
| GSK Investigational Site | |
| Monterey Park, California, United States, 91754 | |
| GSK Investigational Site | |
| Northridge, California, United States, 91328 | |
| GSK Investigational Site | |
| Oxnard, California, United States, 93030 | |
| GSK Investigational Site | |
| Vallejo, California, United States, 94589 | |
| GSK Investigational Site | |
| Fullerton, California, United States, 92835 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92120 | |
| GSK Investigational Site | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| GSK Investigational Site | |
| Gainesville, Florida, United States, 32605 | |
| GSK Investigational Site | |
| Plantation, Florida, United States, 33324 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| GSK Investigational Site | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Robbinsdale, Minnesota, United States, 55422 | |
| GSK Investigational Site | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Montana | |
| GSK Investigational Site | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Voorhees, New Jersey, United States, 08043 | |
| GSK Investigational Site | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10032 | |
| GSK Investigational Site | |
| Manhasset, New York, United States, 11030 | |
| GSK Investigational Site | |
| East Setauket, New York, United States, 11733 | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14642 | |
| GSK Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| GSK Investigational Site | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599 | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| GSK Investigational Site | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98109 | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, C1455BWU | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, C1426ANZ | |
| Australia, New South Wales | |
| GSK Investigational Site | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| South Brisbane, Queensland, Australia, 4101 | |
| Belgium | |
| GSK Investigational Site | |
| Leuven, Belgium, 3000 | |
| GSK Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| GSK Investigational Site | |
| Roeselare, Belgium, 8800 | |
| GSK Investigational Site | |
| Brasschaat, Belgium, 2930 | |
| GSK Investigational Site | |
| Bruxelles, Belgium, 1000 | |
| GSK Investigational Site | |
| Gent, Belgium, 9000 | |
| GSK Investigational Site | |
| Bruxelles, Belgium, 1070 | |
| GSK Investigational Site | |
| Kortrijk, Belgium, 8500 | |
| GSK Investigational Site | |
| Charleroi, Belgium, 6000 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Weston, Ontario, Canada, M9N 1N8 | |
| GSK Investigational Site | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| GSK Investigational Site | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| GSK Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| France | |
| GSK Investigational Site | |
| Dijon Cedex, France, 21079 | |
| GSK Investigational Site | |
| Paris Cedex 20, France, 75970 | |
| GSK Investigational Site | |
| Saint-Herblain, France, 44805 | |
| GSK Investigational Site | |
| Vandoeuvre-Les-Nancy, France, 54511 | |
| GSK Investigational Site | |
| Paris, Cedex, France, 75651 | |
| GSK Investigational Site | |
| Bordeaux Cedex, France, 33076 | |
| GSK Investigational Site | |
| Saint-Cloud, France, 92210 | |
| GSK Investigational Site | |
| Villejuif Cedex, France, 94805 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 13595 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22457 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Stuttgart, Baden-Wuerttemberg, Germany, 70176 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Augsburg, Bayern, Germany, 86150 | |
| GSK Investigational Site | |
| Munchen, Bayern, Germany, 81675 | |
| GSK Investigational Site | |
| Erlangen, Bayern, Germany, 91054 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Ibbenbueren, Nordrhein-Westfalen, Germany, 49477 | |
| Japan | |
| GSK Investigational Site | |
| Hokkaido, Japan, 003-0804 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 814-0180 | |
| GSK Investigational Site | |
| Tokyo, Japan, 113-8677 | |
| GSK Investigational Site | |
| Okayama, Japan, 701-0192 | |
| Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 08035 | |
| GSK Investigational Site | |
| Madrid, Spain, 28041 | |
| GSK Investigational Site | |
| Jaen, Spain, 23007 | |
| GSK Investigational Site | |
| Valencia, Spain, 46009 | |
| GSK Investigational Site | |
| Llobregat, Spain, 08907 | |
| GSK Investigational Site | |
| Tarrasa, Spain, 08221 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08036 | |
| GSK Investigational Site | |
| Valencia, Spain, 46010 | |
| GSK Investigational Site | |
| Sevilla, Spain, 41013 | |
| GSK Investigational Site | |
| Malaga, Spain, 29020 | |
| United Kingdom | |
| GSK Investigational Site | |
| London, United Kingdom, SW3 6JJ | |
| GSK Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
| United Kingdom, Essex | |
| GSK Investigational Site | |
| Epping, Essex, United Kingdom, CM16 6TN | |
| GSK Investigational Site | |
| Chelmsford, Essex, United Kingdom, CM1 7ET | |
| United Kingdom, Surrey | |
| GSK Investigational Site | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| United Kingdom, West Midlands | |
| GSK Investigational Site | |
| Birmingham, West Midlands, United Kingdom, B18 7QH | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | EGF20008 |
| Study First Received: | June 11, 2003 |
| Last Updated: | May 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062686 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HERCEPTIN refractory Metastatic Breast Cancer Lapatinib |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Lapatinib Protein Kinase Inhibitors Pharmacologic Actions Breast Diseases |