Rollover Study Of Lapatinib In Cancer Patients

An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.