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

This study has been completed.
Sponsor:
Information provided by:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00091585
First received: September 10, 2004
Last updated: May 9, 2007
Last verified: May 2007
History of Changes

September 10, 2004
May 9, 2007
June 2004
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Complete list of historical versions of study NCT00091585 on ClinicalTrials.gov Archive Site
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Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors.
Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Initial Safety and Pharmacokinetic Profiles of Intravenous Administration of SNS-595 in Patients With Advanced Malignancies

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

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: SNS-595
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2006
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Inclusion Criteria:

  • 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 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 (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00091585
SPO-0001
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Sunesis Pharmaceuticals
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Study Director: Daniel C. Adelman, MD Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP