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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
  Purpose

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


Condition Intervention Phase
Neoplasms
 Drug: SNS-595
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sunesis Pharmaceuticals:

Study Start Date: June 2004
Estimated Study Completion Date: November 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00091585     History of Changes
Other Study ID Numbers: SPO-0001
Study First Received: September 10, 2004
Last Updated: May 9, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013