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

Not Recruiting

Trial ID: NCT00519662

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

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

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.

Intervention(s):

drug: SNS-314

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
6507362563

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