Status:
COMPLETED
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three do...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 29 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00359190
Start Date
June 29 2004
End Date
January 9 2008
Last Update
November 13 2017
Active Locations (10)
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1
GSK Investigational Site
Miami, Florida, United States, 33136-1002
2
GSK Investigational Site
Durham, North Carolina, United States, 27710
3
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
4
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213