Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies
- 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
- Hemoglobin > or = to 9.0 g/dL
- Absolute Neutrophil Count > or = to 1,500
- Platelets > or = to 100,000
- Calculated or measured creatinine clearance < 50 mL/min
- Serum creatinine < or = 1.5 times the upper limit of normal (ULN)
- AST, ALT, Alkaline Phosphatase < 3 times ULN except if there is hepatic involvement
then AST, ALT, and Alkaline Phosphatase < or = to 5 times ULN
- Total Bilirubin < or = to 2 mg/dL
- Prior exposure to SNS-595
- 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 (i.e., hemophilia, von Willebrand Disease, coagulopathy,
- 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.