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Completed

NCT Number: NCT00519662

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

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

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Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SNS-314

Drug

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

Primary outcomes

  1. To assess the safety and tolerability of SNS-314

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Sunesis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 22, 2007
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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