S-3304 in Treating Patients With Advanced Solid Tumors
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of S-3304 in Patients With Solid Tumors|
|Study Start Date:||October 2001|
|Study Completion Date:||January 2003|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Patrick J. Creaven, MBBS, PhD||Roswell Park Cancer Institute|