Trial | NCT00091585  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vosaroxin ...

  • Study Participants

    None
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.
Study Started
Jun 30
2004
Study Completion
Nov 30
2006
Last Update
May 10
2007
Estimate

Drug SNS-595

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.
No Results Posted