A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
• •Hematological malignancies
• •Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
• •History of seizure disorder
• •Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) \> class II, or uncontrolled hypertension
• •Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
• •Specified concomitant medications
• •Serum creatinine \> 1.5 x upper limit of normal (ULN)
• •Elevated liver enzymes (AST/ALT) \> 2.5 x ULN, or \> 5.0 x ULN if secondary to liver metastases; alkaline phosphatase \> 2.5 x ULN or \> 5.0 x ULN if secondary to liver or bone metastases; total bilirubin \> 1.5 x ULN
• •Radiation therapy within 14 days of study day 1
• •Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
• •Concurrent radiation therapy is not permitted throughout the course of the study