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|
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 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|