S-3304 in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00033566
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2002-04-09
• Primary Completion: 2002-12
• Study Completion: 2003-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States