NCT00033215

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2001

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2003

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2003

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

April 9, 2002

Last Update Submit

April 24, 2018

Conditions

Solid Tumors

Keywords

neovascularizationmatrix metalloproteinasesantiangiogenesistype IV collagenases

Interventions

S-3304DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)

You may not qualify if:

  • Patients with other serious illnesses
  • Patients who are receiving treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado Hospital

Denver, Colorado, 80262, United States

Location

H. Lee Moffitt Concer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Roswell Park Cancer Center

Buffalo, New York, 14263, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 17404091RESULT

MeSH Terms

Conditions

Neovascularization, Pathologic

Interventions

S 3304

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

April 10, 2002

Study Start

November 1, 2001

Primary Completion

February 13, 2003

Study Completion

March 12, 2003

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(4)