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CompletedNCT00033566Updated Mar 7, 2011

S-3304 in Treating Patients With Advanced Solid Tumors

A Phase 1 interventional study of S-3304 in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-07.

Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Estimate the starting dose of this drug for subsequent phase II efficacy studies.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

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

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Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
  • Biopsy-accessible lesion
  • No brain metastasis unless clinically stable and off therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • Transaminases less than 2.5 times ULN

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study
  • Able to tolerate oral medication
  • HIV negative
  • No AIDS
  • No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
  • No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
  • No other concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • No prior significant gastric resection

Other:

  • Recovered from prior therapy
  • At least 4 weeks since other prior investigational antitumor drugs
  • No other concurrent investigational antitumor drugs
  • Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • DrugS-3304
06

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, 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 Mar 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00033566
Lead sponsor
Roswell Park Cancer Institute
First posted
Jan 27, 2003
Start date
Oct 2001
Primary completion
Dec 2002
Completion
Jan 2003
Last update
Mar 7, 2011

Study contacts

Patrick J. Creaven, MBBS, PhD
study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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