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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals

Criteria

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.