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

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. Identifier: NCT00033215
Recruitment Status : Completed
First Posted : April 10, 2002
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: S-3304 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of S-3304 in Patients With Solid Tumors
Actual Study Start Date : November 2001
Actual Primary Completion Date : February 13, 2003
Actual Study Completion Date : March 12, 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00033215

United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80262
United States, Florida
H. Lee Moffitt Concer Center and Research Institute
Tampa, Florida, United States, 33612
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

Publications of Results:
Responsible Party: Shionogi Identifier: NCT00033215     History of Changes
Other Study ID Numbers: 0110P1416
First Posted: April 10, 2002    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shionogi Inc. ( Shionogi ):
matrix metalloproteinases
type IV collagenases

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