Status:
COMPLETED
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- For additional information on this trial, please call (910) 558-2913
- Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-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
- Symptomatic brain metastasis
- Any condition requiring chronic use of steroids
- Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms
- History of glucose intolerance
- Women of child-bearing potential unwilling or unable to use acceptable contraception methods
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00788333
Start Date
July 1 2009
End Date
November 1 2011
Last Update
July 13 2012
Active Locations (9)
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1
Local Institution
Kurralta Park, South Australia, Australia, 5037
2
Local Institution
Frankston, Victoria, Australia, 3199
3
Local Institution
Geelong, Victoria, Australia, 3220
4
Local Institution
Brussels, Belgium, 1000