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

Phase 1
18 Years
Not Enrolling
Neoplasms, Breast, Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen

Outcome Time Frame:

Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Israel: Ministry of Health

Study ID:




Start Date:

August 2004

Completion Date:

May 2009

Related Keywords:

  • Neoplasms, Breast
  • Cancer
  • safety
  • tolerating lapatinib
  • Lapatinib
  • Breast Neoplasms
  • Neoplasms



GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Hooksett, New Hampshire  03106
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Germantown, Tennessee  38138