Last updated: 11/04/2018 06:27:22

GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

GSK study ID
EGF105635
See study documents
Clinicaltrials.gov ID
NCT00371488
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: Phase I study of lapatinib in combination with trastuzumab
Trial description: This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly

Timeframe: 6 Months

Secondary outcomes:

Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue

Timeframe: 6 Months

Interventions:
  • Drug: GW572016 oral tablets
    • Enrollment:
    11
    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)
    April 2006 to December 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 74 years
    Accepts healthy volunteers
    No
    • Patients with confirmed breast cancer who have received prior trastuzumab.
    • Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
    • Patients with certain heart problems.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with confirmed breast cancer who have received prior trastuzumab.
    • Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
    • Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
    Exclusion criteria:
    • Patients with certain heart problems.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Saitama, Japan, 350-1298
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 135-8550
    Status
    Study Complete
    Contact us

    Study documents

    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
    2007-10-12

    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 EGF105635 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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