Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

May 9, 2007 updated by: Sunesis Pharmaceuticals

Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Arizona Cancer Center
      • Tucson, Arizona, United States
        • Arizona Cancer Center
    • California
      • Stanford, California, United States
        • Stanford University Medical Center
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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:

  • Prior exposure to SNS-595
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunesis Pharmaceuticals

Investigators

  • Study Director: Daniel C. Adelman, MD, Sunesis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

October 14, 2004

First Submitted That Met QC Criteria

October 14, 2004

First Posted (Estimate)

October 15, 2004

Study Record Updates

Last Update Posted (Estimate)

May 10, 2007

Last Update Submitted That Met QC Criteria

May 9, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • SPO-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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