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CompletedNCT00033215Updated Apr 26, 2018

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

A Phase 1 interventional study of S-3304 in Solid Tumors, sponsored by Shionogi. Completed at 4 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Shionogi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2003, 23 years 7 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Nov 2001, registered Apr 2002).
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Solid Tumors

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Keywords

  • neovascularization
  • matrix metalloproteinases
  • antiangiogenesis
  • type IV collagenases
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shionogi is the lead sponsor of 104 studies on the registry; 10 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Interventions

  • DrugS-3304
06

Study locations

4 sites
  • University of Colorado Hospital
    Denver, Colorado 80262, United States
  • H. Lee Moffitt Concer Center and Research Institute
    Tampa, Florida 33612, United States
  • Roswell Park Cancer Center
    Buffalo, New York 14263, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
07

References and documents

Publications

  • 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. doi: 10.1158/1078-0432.CCR-06-1586. PubMed 17404091 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00033215
Lead sponsor
Shionogi
Responsible party
Sponsor
First posted
Apr 10, 2002
Start date
Nov 2001
Primary completion
Feb 13, 2003
Completion
Mar 12, 2003
Last update
Apr 26, 2018

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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