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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 10, 2004

Last Updated Date

May 9, 2007

Start Date ^†

June 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00091585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Neoplasms

Intervention ^†

Drug: SNS-595

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

November 2006

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00091585

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Sunesis Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Daniel C. Adelman, MD

Sunesis Pharmaceuticals

Information Provided By

Sunesis Pharmaceuticals

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.