Clinical trial · Interventional
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
NCT00519662CI-TRIAL-00026754completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNS-314 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalating cohorts of SNS-314
- description
- 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.
- interventionNames
- Drug: SNS-314
Primary outcomes (1)
- measure
- To assess the safety and tolerability of SNS-314
- timeFrame
- 1 Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.