Rollover Study Of Lapatinib In Cancer Patients

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Neoplasms, Breast

Treatments

Drug: GW572016 oral tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00169533

EGF19060

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.