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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00075270 |
Purpose
The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Paclitaxel Drug: GW572016 (Lapatinib) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer |
| Enrollment: | 570 |
| Study Start Date: | January 2004 |
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, Arizona | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| GSK Investigational Site | |
| Vallejo, California, United States, 94589 | |
| GSK Investigational Site | |
| La Jolla, California, United States, 92093-0987 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| GSK Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| GSK Investigational Site | |
| Altamonte Springs, Florida, United States, 32701 | |
| GSK Investigational Site | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30341 | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31405 | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Glen Burnie, Maryland, United States, 21225 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| GSK Investigational Site | |
| Nyack, New York, United States, 10960 | |
| United States, North Dakota | |
| GSK Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37916 | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Amarillo, Texas, United States, 79106 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, 1425 | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, C1426ANZ | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, C1405CBA | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Malvern, Victoria, Australia, 3144 | |
| GSK Investigational Site | |
| Wodonga, Victoria, Australia, 3690 | |
| Australia, Western Australia | |
| GSK Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Belgium | |
| GSK Investigational Site | |
| Kortrijk, Belgium, 8500 | |
| GSK Investigational Site | |
| Roeselare, Belgium, 8800 | |
| GSK Investigational Site | |
| Leuven, Belgium, 3000 | |
| GSK Investigational Site | |
| Brussels, Belgium, 1070 | |
| GSK Investigational Site | |
| Brussel, Belgium, 1090 | |
| Brazil | |
| GSK Investigational Site | |
| Rio de Janeiro, Brazil, 20560-120 | |
| Brazil, Bahía | |
| GSK Investigational Site | |
| Salvador, Bahía, Brazil, 41825-010 | |
| Canada, Newfoundland and Labrador | |
| GSK Investigational Site | |
| Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| GSK Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Chile, Región Metro De Santiago | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7500921 | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7591046 | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile | |
| Czech Republic | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| GSK Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| GSK Investigational Site | |
| Brno, Czech Republic, 656 53 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 10117 | |
| GSK Investigational Site | |
| Berlin, Germany, 10367 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22457 | |
| GSK Investigational Site | |
| Hamburg, Germany, 20259 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22765 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Stuttgart, Baden-Wuerttemberg, Germany, 70190 | |
| GSK Investigational Site | |
| Ulm, Baden-Wuerttemberg, Germany, 89075 | |
| GSK Investigational Site | |
| Aalen, Baden-Wuerttemberg, Germany, 73428 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80637 | |
| GSK Investigational Site | |
| Coburg, Bayern, Germany, 96450 | |
| Germany, Brandenburg | |
| GSK Investigational Site | |
| Fuerstenwalde, Brandenburg, Germany, 15517 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Ibbenbueren, Nordrhein-Westfalen, Germany, 49477 | |
| Germany, Schleswig-Holstein | |
| GSK Investigational Site | |
| Kiel, Schleswig-Holstein, Germany, 24103 | |
| Germany, Thueringen | |
| GSK Investigational Site | |
| Jena, Thueringen, Germany, 07743 | |
| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1082 | |
| GSK Investigational Site | |
| Szombathely, Hungary, 9700 | |
| GSK Investigational Site | |
| Zalaegerszeg-Pózva, Hungary, 8900 | |
| GSK Investigational Site | |
| Nyíregyháza, Hungary, 4400 | |
| Italy, Campania | |
| GSK Investigational Site | |
| Benevento, Campania, Italy, 82100 | |
| GSK Investigational Site | |
| Napoli, Campania, Italy, 80131 | |
| Italy, Emilia-Romagna | |
| GSK Investigational Site | |
| Parma, Emilia-Romagna, Italy, 43100 | |
| GSK Investigational Site | |
| Forlì, Emilia-Romagna, Italy, 47100 | |
| GSK Investigational Site | |
| Rimini, Emilia-Romagna, Italy, 47900 | |
| GSK Investigational Site | |
| Ravenna, Emilia-Romagna, Italy, 48100 | |
| Italy, Lazio | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00157 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00152 | |
| Italy, Liguria | |
| GSK Investigational Site | |
| Pietra Ligure (SV), Liguria, Italy, 17027 | |
| Italy, Lombardia | |
| GSK Investigational Site | |
| Pavia, Lombardia, Italy, 27100 | |
| GSK Investigational Site | |
| Bergamo, Lombardia, Italy, 24128 | |
| Italy, Piemonte | |
| GSK Investigational Site | |
| Torino, Piemonte, Italy, 10153 | |
| GSK Investigational Site | |
| Candiolo (TO), Piemonte, Italy, 10060 | |
| Italy, Sardegna | |
| GSK Investigational Site | |
| Sassari, Sardegna, Italy, 07100 | |
| Italy, Toscana | |
| GSK Investigational Site | |
| Prato (PO), Toscana, Italy, 59100 | |
| Italy, Umbria | |
| GSK Investigational Site | |
| Perugia, Umbria, Italy, 06156 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| GSK Investigational Site | |
| Gyeonggi-do, Korea, Republic of, 411-769 | |
| Latvia | |
| GSK Investigational Site | |
| Liepaja, Latvia, LV3401 | |
| GSK Investigational Site | |
| Daugavpils, Latvia, LV5420 | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1002 | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1079 | |
| Mexico | |
| GSK Investigational Site | |
| Colima, Mexico, 28010 | |
| GSK Investigational Site | |
| Durango, Mexico, 34000 | |
| Mexico, Guerrero | |
| GSK Investigational Site | |
| Acapulco, Guerrero, Mexico, 39670 | |
| Mexico, Jalisco | |
| GSK Investigational Site | |
| Guadalajara, Jalisco, Mexico, CP44280 | |
| Netherlands | |
| GSK Investigational Site | |
| UTRECHT, Netherlands, 3584 CX | |
| GSK Investigational Site | |
| NIEUWEGEIN, Netherlands, 3435 CM | |
| GSK Investigational Site | |
| AMERSFOORT, Netherlands, 3816 CP | |
| GSK Investigational Site | |
| UTRECHT, Netherlands, 2584 CX | |
| New Zealand | |
| GSK Investigational Site | |
| Christchurch, New Zealand, 8001 | |
| GSK Investigational Site | |
| Auckland, New Zealand, 1001 | |
| Pakistan | |
| GSK Investigational Site | |
| Lahore, Pakistan, 54000 | |
| Peru | |
| GSK Investigational Site | |
| Callao, Peru, Callao 2 | |
| GSK Investigational Site | |
| Lima, Peru, Lima 34 | |
| Poland | |
| GSK Investigational Site | |
| Poznan, Poland, 61-866 | |
| GSK Investigational Site | |
| Warszawa, Poland, 02-781 | |
| GSK Investigational Site | |
| Wroclaw, Poland, 53-413 | |
| GSK Investigational Site | |
| Krakow, Poland, 31-826 | |
| GSK Investigational Site | |
| Olsztyn, Poland, 10-228 | |
| GSK Investigational Site | |
| Olsztyn, Poland, 10-226 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129301 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129 128 | |
| GSK Investigational Site | |
| Moscow Region, Russian Federation, 143 423 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115 478 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 107005 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 197758 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 197022 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117997 | |
| Slovakia | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 833 10 | |
| GSK Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| GSK Investigational Site | |
| Kosice, Slovakia, 041 91 | |
| South Africa | |
| GSK Investigational Site | |
| Pretoria, South Africa, 0084 | |
| GSK Investigational Site | |
| Port Elizabeth, South Africa, 6001 | |
| GSK Investigational Site | |
| OVERPORT, South Africa, 4000 | |
| Spain | |
| GSK Investigational Site | |
| Madrid, Spain, 28035 | |
| GSK Investigational Site | |
| Caceres, Spain, 10003 | |
| GSK Investigational Site | |
| Las Palmas De Gran Canaria, Spain, 35016 | |
| GSK Investigational Site | |
| La Laguna (Santa Cruz de Tenerife), Spain, 38320 | |
| GSK Investigational Site | |
| Palma de Mallorca, Spain, 07014 | |
| GSK Investigational Site | |
| Jaen, Spain, 23007 | |
| GSK Investigational Site | |
| Alcorcon, Spain, 28922 | |
| GSK Investigational Site | |
| Zaragoza, Spain, 50009 | |
| GSK Investigational Site | |
| Baracaldo/Vizcaya, Spain, 48903 | |
| GSK Investigational Site | |
| Cuidad Real, Spain, 13002 | |
| GSK Investigational Site | |
| Zaragoza, Spain | |
| GSK Investigational Site | |
| Móstoles/Madrid, Spain, 28935 | |
| GSK Investigational Site | |
| San Sebastián, Spain, 20014 | |
| GSK Investigational Site | |
| Pontevedra, Spain, 36071 | |
| Turkey | |
| GSK Investigational Site | |
| Istanbul, Turkey, 34865 | |
| GSK Investigational Site | |
| Istanbul, Turkey | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | EGF30001 |
| Study First Received: | January 7, 2004 |
| Last Updated: | December 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00075270 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
|
lapatinib metastatic breast cancer EGFR Her2-neu |
ErbB1 ErbB2 kinase inhibitor |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Lapatinib Antimitotic Agents Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |