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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2003 by Shionogi.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00033215
First Posted: April 10, 2002
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shionogi
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of S-3304 in Patients With Solid Tumors

Further study details as provided by Shionogi:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00033215     History of Changes
Other Study ID Numbers: 0110P1416
First Submitted: April 9, 2002
First Posted: April 10, 2002
Last Update Posted: June 24, 2005
Last Verified: November 2003

Keywords provided by Shionogi:
neovascularization
matrix metalloproteinases
antiangiogenesis
type IV collagenases

Additional relevant MeSH terms:
S 3304
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action