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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tablets, Oral, Dose escalation to MTD, then MTD to response/EOT, once daily, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
IV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
Local Institution
Kurralta Park, South Australia, Australia
Local Institution
Frankston, Victoria, Australia
Local Institution
Geelong, Victoria, Australia
Local Institution
Brussels, Belgium
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Budapest, Hungary
Local Institution
Miskolc, Hungary
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
Time frame: Every 30 days until MTD is reached
Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)
Time frame: Every 8 weeks
Evaluate safety and tolerability of the combination regimen
Time frame: Ongoing
Assess effect of combination therapy on glucose metabolism
Time frame: At 30 days, then every 8 weeks
Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia
Time frame: Ongoing
Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis
Time frame: Days, 1,8,15,22
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