Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024063
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-09-13
Brief Title:
SU006668 in Treating Patients With Advanced Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of SU006668 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of SU006668 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of SU006668 in patients with advanced solid tumors II Determine the pharmacokinetics of this drug in these patients III Determine the objective response of patients treated with this drug IV Determine the toxic effects of this drug in these patients
OUTLINE This is a dose-escalation study Patients receive oral SU006668 twice daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity Patients are followed at 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive oral SU006668 twice daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity Patients are followed at 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G01-2010 | None | None | None |
| UCLA-0004061 | None | None | None |
| SUGEN-SU6668004 | None | None | None |