Rollover Study Of Lapatinib In Cancer Patients
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms, Breast; Cancer
Intervention: GW572016 oral tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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 available pending FDA approval.
Clinical Details
Official title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen
Secondary outcome: Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Investigational Site, Tel Aviv 64239, Israel
GSK Investigational Site, Edmonton, Alberta T6G 1Z2, Canada
GSK Investigational Site, Indianapolis, Indiana 46202, United States
GSK Investigational Site, Lebanon, New Hampshire 03756, United States
GSK Investigational Site, Albuquerque, New Mexico 87131, United States
GSK Investigational Site, Chapel Hill, North Carolina 27599, United States
GSK Investigational Site, Durham, North Carolina 27705, United States
GSK Investigational Site, Cleveland, Ohio 44106, United States
GSK Investigational Site, Philadelphia, Pennsylvania 19111, United States
GSK Investigational Site, Nashville, Tennessee 37203, United States
GSK Investigational Site, San Antonio, Texas 78229, United States
Additional Information
Starting date: August 2004
Last updated: April 21, 2011
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