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

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

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

Official Title
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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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: SNS-314


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalating cohorts of SNS-314<br>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. | Drug: SNS-314<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of SNS-314 |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid, Tumors, Advanced