ClinicalTrials.gov
ClinicalTrials.gov Menu

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

April 9, 2002
April 10, 2002
April 26, 2018
November 2001
February 13, 2003   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00033215 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase 1 Study of S-3304 in Patients With Solid Tumors
A Phase 1 Study of S-3304 in Patients With Solid Tumors
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
Not Provided
Interventional
Phase 1
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
Solid Tumors
Drug: S-3304
Not Provided
Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
28
March 12, 2003
February 13, 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00033215
0110P1416
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Shionogi Inc. ( Shionogi )
Shionogi
Not Provided
Not Provided
Shionogi Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP