Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of SNS-314

Outcome Time Frame:

1 Year

Safety Issue:

Yes

Principal Investigator

Glenn Michelson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0011

NCT ID:

NCT00519662

Start Date:

August 2007

Completion Date:

March 2009

Related Keywords:

  • Advanced Solid Tumors
  • Solid
  • Tumors
  • Advanced
  • Neoplasms

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Duke UniversityDurham, North Carolina  27710
University of New MexicoAlbuquerque, New Mexico  87131
University of Alabama, BirminghamBirmingham, Alabama  35233