Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033566
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2002-04-09
Brief Title:
S-3304 in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of S-3304 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-0120 | None | None | None |