Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors

Inclusion criteria

• Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
• ECOG performance status of 0, 1, or 2
• Adequate hematological status
• Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
• 18 years of age or older
• Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
• For phase 1b portion only: metastatic breast cancer

Exclusion criteria

• Hematologic malignancies
• Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
• Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA > class II, uncontrolled hypertension
• Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
• Major surgery within 1 month of study day 1
• History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
• History of seizure disorder or currently on anti-seizure medication
• Systemic chemotherapy or radiation therapy within 28 days of study day 1
• Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
• Evidence of liver disease shown by elevated enzymes
• Evidence of renal disease shown by serum creatinine > 1.5 x upper limit of normal
• Currently receiving platelet of GCF support for any medical condition
• Concurrent use of herbal medications taken with the intent to treat cancer
• Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study