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

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ClinicalTrials.gov Identifier: NCT00091585
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : May 10, 2007
Sponsor:
Information provided by:
Sunesis Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: SNS-595 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2004
Study Completion Date : November 2006




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091585


Locations
United States, Arizona
Arizona Cancer Center
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
United States, California
Stanford University Medical Center
Stanford, California, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
Study Director: Daniel C. Adelman, MD Sunesis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00091585     History of Changes
Other Study ID Numbers: SPO-0001
First Posted: September 14, 2004    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: May 2007