Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors

Phase 1 Open-Label Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-314, a Novel Aurora Kinase Inhibitor, Administered to Patients With Advanced Solid Tumors

This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).

Inclusion Criteria:

• Advanced solid tumor and that is measurable by a scan

Exclusion Criteria:

• Uncontrolled or untreated central nervous system metastases
• Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
• Any of the following cardiac conditions:
• History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
• Class III or IV heart failure up to 6 months before Cycle 1 Day 1
• Baseline heart rate corrected QT interval (QTc)> 450 msec
• History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
• Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
• Previous cancer treatment up to 21 days before first dose
• Any investigational therapy up to 28 days before Cycle 1 Day 1
• Known allergy to cyclodextrins

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.