NCT00094159

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2004

Completed
Last Updated

May 10, 2007

Status Verified

May 1, 2007

First QC Date

October 14, 2004

Last Update Submit

May 9, 2007

Conditions

Neoplasms

Interventions

SNS-595DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must give written informed consent
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona Cancer Center

Scottsdale, Arizona, United States

Location

Arizona Cancer Center

Tucson, Arizona, United States

Location

Stanford University Medical Center

Stanford, California, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vosaroxin

Study Officials

  • Daniel C. Adelman, MD

    Sunesis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2004

First Posted

October 15, 2004

Study Start

October 1, 2004

Last Updated

May 10, 2007

Record last verified: 2007-05

Locations

US(4)