Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors
NCT ID: NCT00519662
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2007-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sunesis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Glenn Michelson, MD
Role: STUDY_DIRECTOR
Sunesis Pharmaceuticals
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Stanford, California, United States
University of New Mexico
Albuquerque, New Mexico, United States
Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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SPO-0011
Identifier Type: -
Identifier Source: org_study_id
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