Rollover Study Of Lapatinib In Cancer Patients

Completed · Phase 1

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT00169533

Run by

GlaxoSmithKline

People needed

31

Starts

2004-08-19

Expected to finish

2009-05-05

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Tel Aviv, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.