RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in treating patients with metastatic solid tumors.
OBJECTIVES: Primary * Determine the maximum tolerated dose, biologically active dose, and recommended phase II dose(s) of BMS-599626 in patients with metastatic HER2/neu-overexpressing primary solid tumors. Secondary * Determine the safety and tolerability of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the effect of this drug on biomarkers and predictive markers of HER1 and HER2 in skin and tumor in these patients. * Evaluate tumor metabolic activity in response to this drug in these patients. * Determine, preliminarily, evidence of anti-tumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral BMS-599626 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-599626 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 patients are treated at that dose level. PROJECTED ACCRUAL: Approximately 3-60 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
maximum tolerated dose of BMS-599626
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.