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

NCT ID: NCT00033215

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-03-12

Brief Summary

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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

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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S-3304

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with other serious illnesses
* Patients who are receiving treatments
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

H. Lee Moffitt Concer Center and Research Institute

Tampa, Florida, United States

Site Status

Roswell Park Cancer Center

Buffalo, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17404091 (View on PubMed)

Other Identifiers

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0110P1416

Identifier Type: -

Identifier Source: org_study_id

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