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GW572016 For Treatment Of Refractory Metastatic Breast Cancer
This study has been completed.
First Received: June 11, 2003   Last Updated: May 28, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Tumor response rate

Secondary Outcome Measures:
  • clinical benefit rate time to progression 4 and 6 month progression free survival overall survival

Estimated Enrollment: 200
Study Start Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent.
  • Histologically confirmed Stage IIIb or IV breast cancer.
  • Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
  • Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
  • Documented disease progression of the most recent treatment is required.
  • Archived tumor tissue available for testing.
  • Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
  • At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
  • Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

Exclusion criteria:

  • Pregnant or lactating.
  • Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
  • Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
  • History of other malignancy.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Active or uncontrolled infection.
  • Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  • Known history of or clinical evidence of leptomeningeal carcinomatosis.
  • Active infection.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062686

  Hide Study Locations
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:
HERCEPTIN refractory
Metastatic Breast Cancer
Lapatinib

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009