Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors
NCT ID: NCT00094159
Last Updated: 2007-05-10
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
INTERVENTIONAL
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SNS-595
Eligibility Criteria
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Inclusion Criteria
* 18 years of age
* Advanced solid malignant tumors
* Tumor can be measured and evaluated
* Blood tests are within standard limits
* Normal blood coagulation
* ECOG Performance Status equal to 0 or 1
* Hemoglobin \> or = to 9.0 g/dL
* Absolute Neutrophil Count \> or = to 1,500
* Platelets \> or = to 100,000
* Calculated or measured creatinine clearance \< 50 mL/min
* Serum creatinine \< or = 1.5 times the upper limit of normal (ULN)
* AST, ALT, Alkaline Phosphatase \< 3 times ULN except if there is hepatic involvement then AST, ALT, and Alkaline Phosphatase \< or = to 5 times ULN
* Total Bilirubin \< or = to 2 mg/dL
Exclusion Criteria
* Pregnant or breastfeeding.
* Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
* Requires kidney dialysis (hemodialysis or peritoneal).
* Known bleeding disorder (i.e., hemophilia, von Willebrand Disease, coagulopathy, etc.).
* Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
* Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
* Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
* Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
18 Years
ALL
No
Sponsors
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Sunesis Pharmaceuticals
INDUSTRY
Principal Investigators
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Daniel C. Adelman, MD
Role: STUDY_DIRECTOR
Sunesis Pharmaceuticals
Locations
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Arizona Cancer Center
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Stanford University Medical Center
Stanford, California, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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SPO-0002
Identifier Type: -
Identifier Source: org_study_id