Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Initial Safety and Pharmacokinetic Profiles of Intravenous Administration of SNS-595 in Patients With Advanced Malignancies

Inclusion Criteria:

- Must give written informed consent

- 18 years of age

- Advanced solid malignant tumors

- Tumor can be measured and evaluated

- Blood tests are within standard limits

- Normal blood coagulation

- ECOG Performance Status equal to 0 or 1

Exclusion Criteria:

- Pregnant or breastfeeding.

- Women of childbearing potential unwilling to use an approved, effective means of
contraception according to the institution’s standards.

- Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or
pulmonary embolus) within 6 months before the screen visit.

- Requires kidney dialysis (hemodialysis or peritoneal).

- Known bleeding disorder (ie, hemophilia, von Willebrand Disease, coagulopathy, etc.).

- Received an investigational agent or prior chemotherapy or immunotherapy within 28
days before first dose of SNS-595

- Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).

- Currently receiving corticosteroids (inhaled steroids for breathing diseases are
allowed) or seizure medications.

- Any medical, psychological, or social condition that, in the opinion of the Principal
Investigator, would contraindicate the patient's participation in the clinical trial
due to safety and or compliance with study procedures.