Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00169533
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00169533
Study Brief:
Protocol Section:
NCT00169533