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

Study start date: March 1, 2006

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