This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
1250mg lapatinib
1250mg lapatinib plus esomeprazole 40mg
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Songpa-gu, Seoul, South Korea
GSK Investigational Site
Hospitalet de Llobregat (Barcelona), Spain
The area under the concentration versus time curve, minimum observed concentration, maximum observed concentration, time at which it occurs, and lag time in the appearance of measurable plasma concentrations of lapatinb
Time frame: Continue until disease progression or withdrawal consent
Safety and tolerability assessments including evaluation of adverse events and changes in laboratory values, and vital signs.
Time frame: Continue until disease progression or withdrawal consent
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