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A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms, Breast, Breast Cancer

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Trial Information

A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer

Inclusion Criteria


Inclusion criteria:

- Clinical labs are within acceptable ranges.

- A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater
that can be readily biopsied.

- At least 18 years of age.

- Females must meet certain criteria specified in protocol.

- Ability to swallow and retain oral medication.

- Ability to follow and understand directions.

Exclusion criteria:

- Female who is pregnant or lactating.

- Medically unfit by the doctor as a result of the medical interview or physicals.

- Received treatment of an investigational drug within 4 weeks of study start.

- Currently receiving treatment with prohibited meds listed in protocol.

- Had major surgery in previous 2 weeks.

- Had prior radiation therapy to the chest to treat this incidence of breast cancer.

- Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study
med.

- Has a malabsorption syndrome.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.

Outcome Description:

biomarker analysis of tumor biopsies pre/post dose

Outcome Time Frame:

subjects on study up to 15 days

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Israel: Ministry of Health

Study ID:

EGF10027

NCT ID:

NCT00359190

Start Date:

June 2004

Completion Date:

January 2008

Related Keywords:

  • Neoplasms, Breast
  • Breast Cancer
  • lapatinib
  • breast cancer
  • treatment-naive
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153