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

Inclusion criteria

• ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
• At least a 14-day period from end of last dose of chemotherapy received
• Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1

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