Completed
A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer
Led by Bristol-Myers Squibb · Updated on 2012-07-13
40
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
- 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
Trial Site Locations
Total: 9 locations
1
Local Institution
Kurralta Park, South Australia, Australia, 5037
Status Unknown
2
Local Institution
Frankston, Victoria, Australia, 3199
Status Unknown
3
Local Institution
Geelong, Victoria, Australia, 3220
Status Unknown
4
Local Institution
Brussels, Belgium, 1000
Status Unknown
5
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Status Unknown
6
Local Institution
Toronto, Ontario, Canada, M5G 1X5
Status Unknown
7
Local Institution
Budapest, Hungary, 1122
Status Unknown
8
Local Institution
Miskolc, Hungary, 3526
Status Unknown
9
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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