Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary solid (i.e., non-hematologic) tumor - Radiographic or tissue confirmation of metastatic disease - Locally advanced disease allowed if no surgical or local therapeutic treatment exists - HER2/neu overexpression (1+, 2+, or 3 +) by immunohistochemistry - Tumors with HER2 gene amplification by fluorescence in situ hybridization analysis allowed - Tumor paraffin tissue block OR 20-30 unstained slides from tumor tissue block must be available for biomarker and predictive marker analyses - Disease progression during or after standard therapy OR no standard therapy exists - Measurable or non-measurable disease - Measurable disease is required for the expanded cohort treated at the maximum tolerated dose of the study drug - No known brain metastasis - Patients with controlled brain metastasis with no disease progression 60 days after prior therapy and no neurologic signs or symptoms are allowed - Patients with signs or symptoms suggestive of brain metastasis are eligible provided that brain metastasis is ruled out by CT scan or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT and AST ≤ 2.5 times ULN - PT/PTT ≤ 1.5 times ULN - INR ≤ 1.5 times ULN Renal - Creatinine ≤ 1.5 times ULN - Calcium normal Cardiovascular - LVEF ≥ 45% - Heart rate ≥ 50 beats/min on electrocardiogram - No uncontrolled cardiovascular disease - No myocardial infarction within the past 12 months - No uncontrolled angina within the past 6 months - No congestive heart failure within the past 6 months - No prolonged QTc (> 450 msec) on electrocardiogram - No diagnosed or suspected congenital long QT syndrome - No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes) - No history of second- or third-degree heart block - Patients with pacemakers may be eligible - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation - Potassium normal - Magnesium normal - No medical condition that has a risk of causing torsades de pointes - No active infection - No serious uncontrolled medical disorder that would preclude study participation - No dementia or altered mental status that would preclude giving informed consent - No known allergy to BMS-599626 or related compound - No prisoners or patients involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy - At least 2 weeks since prior targeted kinase inhibitor (e.g., trastuzumab [Herceptin^®]) Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) Endocrine therapy - At least 2 weeks since prior anticancer hormonal therapy Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - Not specified Other - Recovered from prior therapy - Prior adjuvant or neoadjuvant therapy allowed - No short-acting antacids (e.g., Maalox^® or TUMS^®) 8 hours before or 4 hours after study drug administration - No recent anticancer therapy - More than 4 weeks since prior investigational agents - At least 5 days (or 5 half-lives) since prior drugs that cause torsades de pointes - At least 48 hours since prior proton pump inhibitors (e.g., omeprazole or lansoprazole) or histamine H_2 antagonists (e.g., ranitidine, famotidine, or cimetidine) - Concurrent low-dose coumadin allowed - No other concurrent investigational agents - No concurrent drugs that may cause torsades de pointes or QTc prolongation


NCT ID:

NCT00093730


Primary Contact:

Study Chair
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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