Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

GlaxoSmithKline28 enrolled

Overview

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 dosing schedules of lapatinib.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms, Breast

Interventions

lapatinibDRUG

GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Allentown, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

biomarker analysis of tumor biopsies pre/post dose

Time frame: subjects on study up to 15 days

Secondary Outcomes

Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.

safety assessments of labs, hematology labs, Electrocardiogram, vital signs

Time frame: subjects on study up to 15 days

Data from ClinicalTrials.gov

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