An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms, Breast, Cancer
Both
Neoplasms, Breast, Cancer
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
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.
Type of Study:
Interventional
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:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Israel: Ministry of Health
Study ID:
EGF19060
NCT ID:
NCT00169533
Start Date:
August 2004
Completion Date:
May 2009
Related Keywords:
- Neoplasms, Breast
- Cancer
- safety
- tolerating lapatinib
- Lapatinib
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| 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 |
