Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024206
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2001-09-13
Brief Title:
SU6668 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors
II Assess the safety and tolerability of this therapy in these patients III Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients
IV Determine the extent frequency and duration of any tumor responses in patients treated with this therapy
V Determine a recommended phase II dose of SU6668 for future clinical studies
OUTLINE This is a dose-escalation study
Patients receive oral SU6668 twice daily on days 1-28 Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100 or more
Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose OBD is determined Once the OBD is reached dose escalation continues until the maximum tolerated dose MTD is determined if possible The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
I Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors
II Assess the safety and tolerability of this therapy in these patients III Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients
IV Determine the extent frequency and duration of any tumor responses in patients treated with this therapy
V Determine a recommended phase II dose of SU6668 for future clinical studies
OUTLINE This is a dose-escalation study
Patients receive oral SU6668 twice daily on days 1-28 Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100 or more
Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose OBD is determined Once the OBD is reached dose escalation continues until the maximum tolerated dose MTD is determined if possible The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| CDR0000068900 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |
| ID00-184 | None | None | None |
| U01CA062461 | NIH | None | None |