Status:
COMPLETED
Rollover Study Of Lapatinib In Cancer Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00169533
Start Date
August 19 2004
End Date
May 5 2009
Last Update
November 17 2017
Active Locations (12)
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1
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
2
GSK Investigational Site
Detroit, Michigan, United States, 48201
3
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
4
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131