Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 6:44 PM
Study NCT ID:
NCT00024206
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2001-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU6668 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID00-184 | None | None | View | |
| U01CA062461 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000068900 | REGISTRY | PDQ (Physician Data Query) | View |