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
18 Years
N/A
Both
Neoplasms, Breast, Breast Cancer
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 Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Green Bay, Wisconsin 54301 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | Salem, Virginia 24153 |
