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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00519662

Enrollment

Registered

2007-08-22

Start date

2007-08-31

Completion date

2009-03-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Solid, Tumors, Advanced

Brief summary

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

Detailed description

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

Interventions

DRUGSNS-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of SNS-314	1 Year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026