Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors
This study has been completed.
Information provided by:
First received: August 20, 2007
Last updated: March 5, 2009
Last verified: March 2009
This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
Advanced Solid Tumors
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To assess the safety and tolerability of SNS-314 [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15
Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Advanced solid tumor and that is measurable by a scan
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519662
|University of Alabama, Birmingham
|Birmingham, Alabama, United States, 35233 |
|Stanford University Medical Center
|Stanford, California, United States, 94305 |
|University of New Mexico
|Albuquerque, New Mexico, United States, 87131 |
|Durham, North Carolina, United States, 27710 |
||Glenn Michelson, MD
No publications provided
||Glenn Michelson, MD, Sunesis Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 20, 2007
||March 5, 2009
||United States: Food and Drug Administration
Keywords provided by Sunesis Pharmaceuticals:
ClinicalTrials.gov processed this record on August 26, 2015