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
    1. 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.
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Investigator(s)

Ranjana H Advani
Ranjana H Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma

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

Contact

Sipra Choudhury
6507362563

View on ClinicalTrials.gov