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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunesis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00519662

First received: August 20, 2007

Last updated: March 30, 2017

Last verified: March 2017

History of Changes

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: SNS-314	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
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

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:

To assess the safety and tolerability of SNS-314 [ Time Frame: 1 Year ]


Enrollment:	32
Study Start Date:	August 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dose escalating cohorts of 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.	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

Arms

Assigned Interventions

Experimental: Dose escalating cohorts of 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.

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

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519662

Locations


United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Sunesis Pharmaceuticals

Investigators


Study Director:	Glenn Michelson, MD	Sunesis Pharmaceuticals

More Information


Responsible Party:	Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00519662 History of Changes
Other Study ID Numbers:	SPO-0011
Study First Received:	August 20, 2007
Last Updated:	March 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Sunesis Pharmaceuticals:


Solid Tumors Advanced

ClinicalTrials.gov processed this record on August 16, 2017

To Top