Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
NCT00246662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2017-03-30
Summary
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.
Conditions
- Leukemia, Lymphocytic, Acute
- Leukemia, Nonlymphocytic, Acute
- Leukemia, Myeloid, Chronic
- Myelodysplastic Syndromes
Interventions
- DRUG
-
Vosaroxin
All patients receive vosaroxin Injection
Sponsors & Collaborators
-
Sunesis Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Glenn Michelson, MD · Sunesis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-14
- Primary Completion
- 2008-12-23
- Completion
- 2009-04-30
Countries
- United States
Study Locations
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