Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00519662 |
Recruitment Status :
Completed
First Posted : August 22, 2007
Last Update Posted : April 4, 2017
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors | Drug: SNS-314 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |
Arm | Intervention/treatment |
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Experimental: Dose escalating cohorts of SNS-314
Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema.
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Drug: SNS-314
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 |
- To assess the safety and tolerability of SNS-314 [ Time Frame: 1 Year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519662
United States, Alabama | |
University of Alabama, Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 |
Study Director: | Glenn Michelson, MD | Sunesis Pharmaceuticals |
Responsible Party: | Sunesis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00519662 History of Changes |
Other Study ID Numbers: |
SPO-0011 |
First Posted: | August 22, 2007 Key Record Dates |
Last Update Posted: | April 4, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Solid Tumors Advanced |
Neoplasms |