Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer

Last updated: July 12, 2012
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

1/2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00788333
CA191-004
EUDRACT #: 2009-013766-78
  • Ages > 18
  • Female

Study Summary

This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure

Eligibility Criteria

Inclusion

For additional information on this trial, please call (910) 558-2913 Inclusion Criteria:

  • Subjects with locally advanced or metastatic Her-2-positive breast cancer who havefailed at least one trastuzumab containing regimen. Prior treatment with otherHer-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed

  • Histologic or cytologic diagnosis of Her-2-positive breast cancer

  • ECOG status 0 - 1

Exclusion

Exclusion Criteria:

  • Symptomatic brain metastasis

  • Any condition requiring chronic use of steroids

  • Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2Diabetes Mellitus or prediabetic symptoms

  • History of glucose intolerance

  • Women of child-bearing potential unwilling or unable to use acceptable contraceptionmethods

Study Design

Total Participants: 40
Study Start date:
July 01, 2009
Estimated Completion Date:
November 30, 2011

Connect with a study center

  • Local Institution

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Local Institution

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Local Institution

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Local Institution

    Brussels, 1000
    Belgium

    Site Not Available

  • Local Institution

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Local Institution

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Local Institution

    Budapest, 1122
    Hungary

    Site Not Available

  • Local Institution

    Miskolc, 3526
    Hungary

    Site Not Available

  • Local Institution

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Local Institution

    Manchester, Greater Manchester M20 4BX
    United Kingdom

    Site Not Available

  • Local Institution

    Edinburgh, Midlothian EH4 2XU
    United Kingdom

    Site Not Available

  • Local Institution

    Newcastle Upon Tyne, Tyne And Wear NE7 7DN
    United Kingdom

    Site Not Available

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