Status:

COMPLETED

Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors.

Lead Sponsor:

Sunesis Pharmaceuticals

Conditions:

Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine whether SNS-595 given intravenously once every 3 weeks is safe.

Detailed Description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595...

Eligibility Criteria

Inclusion

  • Must give written informed consent
  • 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

Exclusion

  • 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 (ie, 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.

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

End Date :

November 1 2006

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00091585

Start Date

June 1 2004

End Date

November 1 2006

Last Update

May 10 2007

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Arizona Cancer Center

Scottsdale, Arizona, United States

2

Arizona Cancer Center

Tucson, Arizona, United States

3

Stanford University Medical Center

Stanford, California, United States

4

Duke University Medical Center

Durham, North Carolina, United States

Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors. | DecenTrialz