S-3304 in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00033566|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
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|
- 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)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033566
|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|