Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 8:06 PM
Study NCT ID:
NCT00033566
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2002-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-3304 in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RPCI-DS-0120 | None | None | View |