Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

Sunesis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: SNS-595

Study type

Interventional

Funder types

Industry

Identifiers

NCT00094159

SPO-0002

Details and patient eligibility

About

The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.

Full description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
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

Exclusion criteria

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, 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.