Rollover Study Of Lapatinib In Cancer Patients

• Status: Completed
• Trial end date: 2009-05-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib

Criteria

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.