Last updated: 11/04/2018 06:22:09

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

GSK study ID
EGF10027
See study documents
Clinicaltrials.gov ID
NCT00359190
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: A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients with Treatment- Naive Breast Cancer
Trial description: This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.

Timeframe: subjects on study up to 15 days

Secondary outcomes:

Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.

Timeframe: subjects on study up to 15 days

Interventions:
  • Drug: lapatinib
    • Enrollment:
    28
    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)
    June 2004 to January 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Clinical labs are within acceptable ranges.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Clinical labs are within acceptable ranges.
    • A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
    • At least 18 years of age.
    • Females must meet certain criteria specified in protocol.
    • Ability to swallow and retain oral medication.
    • Ability to follow and understand directions. Exclusion criteria:
    • Female who is pregnant or lactating.
    • Medically unfit by the doctor as a result of the medical interview or physicals.
    • Received treatment of an investigational drug within 4 weeks of study start.
    • Currently receiving treatment with prohibited meds listed in protocol.
    • Had major surgery in previous 2 weeks.
    • Had prior radiation therapy to the chest to treat this incidence of breast cancer.
    • Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
    • Has a malabsorption syndrome.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136-1002
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Zrifin, Israel, 70300
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 10 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
    2008-09-01

    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 EGF10027 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website