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

Trial ID or NCT#

NCT00519662

Status

not recruiting iconNOT RECRUITING

Purpose

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

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Advanced solid tumor and that is measurable by a scan
Exclusion Criteria:
  1. - 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.

Investigator(s)

Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor

Contact us to find out if this trial is right for you.

Contact

Sipra Choudhury
6507362563