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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00051103
Other study ID # EGF 20002
Secondary ID
Status Completed
Phase Phase 2
First received January 3, 2003
Last updated April 14, 2015
Start date October 2002
Est. completion date June 2005

Study information

Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.


Other known NCT identifiers
  • NCT00044330
  • NCT00053066

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Investigational Cancer Drug


Locations

Country Name City State
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Bettendorf Iowa
United States GSK Investigational Site Billings Montana
United States GSK Investigational Site Chula Vista California
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Des Moines Iowa
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Fargo North Dakota
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Germantown Tennessee
United States GSK Investigational Site Greenville North Carolina
United States GSK Investigational Site Hickory North Carolina
United States GSK Investigational Site Hooksett New Hampshire
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Memphis Tennessee
United States GSK Investigational Site Memphis Tennessee
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Park Ridge Illinois
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Poway California
United States GSK Investigational Site Royal Oak Michigan
United States GSK Investigational Site Salem Virginia
United States GSK Investigational Site Savannah Georgia
United States GSK Investigational Site Skokie Illinois
United States GSK Investigational Site Skokie Illinois
United States GSK Investigational Site Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29. — View Citation

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