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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SNS-314

• Registration Number: NCT00519662
• Lead Sponsor: Sunesis Pharmaceuticals

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalating cohorts of SNS-314	SNS-314	Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema.

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of SNS-314	1 Year

Trial Locations

Locations (4)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States