S-3304 in Treating Patients With Advanced 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. Identifier: NCT00033566
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
Information provided by:
Roswell Park Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: S-3304 Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study of S-3304 in Patients With Solid Tumors
Study Start Date : October 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : January 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 weeks


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


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


  • Creatinine less than 2.0 mg/dL


  • 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


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


  • 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


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


  • No prior significant gastric resection


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033566

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Study Chair: Patrick J. Creaven, MBBS, PhD Roswell Park Cancer Institute

Publications of Results:
Responsible Party: Patrick Creaven, MD, Roswell Park Cancer Institute Identifier: NCT00033566     History of Changes
Other Study ID Numbers: CDR0000069301
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
S 3304
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action