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
18 Years
N/A
Both
Advanced Solid Tumors
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the safety and tolerability of SNS-314
Outcome Time Frame:
1 Year
Safety Issue:
Yes
Principal Investigator
Glenn Michelson, MD
Investigator Role:
Study Director
Investigator Affiliation:
Sunesis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
SPO-0011
NCT ID:
NCT00519662
Start Date:
August 2007
Completion Date:
March 2009
Related Keywords:
- Advanced Solid Tumors
- Solid
- Tumors
- Advanced
- Neoplasms
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Duke University | Durham, North Carolina 27710 |
| University of New Mexico | Albuquerque, New Mexico 87131 |
| University of Alabama, Birmingham | Birmingham, Alabama 35233 |
