Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.
Ability to understand and provide written informed consent to participate in this trial.
Is male or female.
Female and male subjects agree to the protocol specific birth control measures
You may not be if
Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
Is a pregnant or lactating female.
Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).
Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Has a left ventricular ejection fraction (LVEF) \< 40% based on MUGA or ECHO.
