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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00519662
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: SNS-314 Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : August 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009
Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519662


Locations
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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
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Study Director: Glenn Michelson, MD Sunesis Pharmaceuticals
More Information
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Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00519662     History of Changes
Other Study ID Numbers: SPO-0011
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sunesis Pharmaceuticals:
Solid
Tumors
Advanced
Additional relevant MeSH terms:
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Neoplasms