NCT00033566

S-3304 in Treating Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	S-3304

Timeline

• Start date: 2001-10-01
• Primary completion: 2002-12-01
• Completion: 2003-01-01
• First posted: 2003-01-27
• Last updated: 2011-03-07

Locations

1 site across 1 country: United States