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

Advanced Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519662
• Other study ID #: SPO-0011
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2007
• Last updated: March 30, 2017
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2017
• Source: Sunesis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• SNS-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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Duke University	Durham	North Carolina
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunesis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of SNS-314		1 Year