A Phase 1 Study of S-3304 in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

First Received: April 9, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Shionogi
Information provided by:	Shionogi
ClinicalTrials.gov Identifier:	NCT00033215

Purpose

To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population

Condition	Intervention	Phase
Solid Tumors	Drug: S-3304	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Study of S-3304 in Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: S 3304

U.S. FDA Resources

Further study details as provided by Shionogi:

Estimated Enrollment:	28
Study Start Date:	November 2001
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)
Must be able to tolerate oral medication Exclusion criteria
Patients with other serious illnesses
Patients who are receiving treatments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033215

Locations

United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80262
United States, Illinois
Rush-Presbyterian-St. Lukes Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Shionogi

More Information

No publications provided

Study ID Numbers:	0110P1416
Study First Received:	April 9, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00033215 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shionogi:

neovascularization
matrix metalloproteinases
antiangiogenesis
type IV collagenases

Study placed in the following topic categories:

Neovascularization, Pathologic

ClinicalTrials.gov processed this record on July 02, 2009