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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer, Neoplasms, Breast

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Trial Information

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


Inclusion Criteria:

(The patient must meet the following criteria in order to be eligible
for this study.)

- Signed informed consent

- No more than two prior regimens for metastatic breast cancer. Each regimen must have
contained Herceptin.

- Refractory Stage IIIb or IV breast cancer

- HER2/neu tumor overexpression

- Disease progression while receiving a prior chemotherapy regimen with Herceptin alone
or in combination with other chemotherapy.

- Tumor tissue available for testing.

- 2 weeks since treatment with Herceptin (alone or in combination).

- Able to swallow and retain oral medication

- Cardiac ejection fraction within the institutional range of normal as measured by
MUGA (Multiple Gated Acquisition Scan).

- Adequate kidney and liver function

- Adequate bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be
eligible for this study.)

- Prior regimens did not include Herceptin.

- Pregnant or lactating.

- Conditions that would affect absorption of an oral drug

- Serious medical or psychiatric disorder that would interfere with the patient's
safety or informed consent.

- Severe cardiovascular disease or cardiac disease requiring a device.

- Active infection.

- Brain metastases.

- Concurrent cancer therapy or investigational therapy.

- Use of oral or IV steroids.

- Unresolved or unstable serious toxicity from prior therapy.

- Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than
Herceptin.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF 20002

NCT ID:

NCT00051103

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Neoplasms, Breast
  • Refractory
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteSt. Louis, Montana  63110
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SiteFargo, North Dakota  58103
GSK Investigational SiteOklahoma City, Oklahoma  73112
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153