Last updated: 11/04/2018 06:32:25

Rollover Study Of Lapatinib In Cancer Patients

GSK study ID
EGF19060
See study documents
Clinicaltrials.gov ID
NCT00169533
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

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

Secondary outcomes:

Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival

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

Interventions:
  • Drug: GW572016 oral tablets
    • Enrollment:
    31
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    August 2004 to May 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • Permanent discontinuation of lapatinib in the previous study due to intolerance or
    • treatment failure.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87131
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Edmonton, Alberta, Canada, T6G 1Z2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19111
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 12 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-05-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study EGF19060 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website