Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00357318
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2006-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bevacizumab and Sunitinib in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of Bevacizumab in Combination With SU11248
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in treating patients with solid tumors. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of bevacizumab in combination with sunitinib malate (SU11248) in patients with solid tumors.
SECONDARY OBJECTIVES:
I. Evaluate the objective response rate, time to disease progression, and overall survival of these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab and SU11248 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.
After completion of study therapy, patients are followed for 30 days.
I. Determine the maximum tolerated dose of bevacizumab in combination with sunitinib malate (SU11248) in patients with solid tumors.
SECONDARY OBJECTIVES:
I. Evaluate the objective response rate, time to disease progression, and overall survival of these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab and SU11248 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.
After completion of study therapy, patients are followed for 30 days.
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 |
|---|---|---|---|---|
| NCI-2009-00185 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000489184 | None | None | View | |
| CASE 5Y05 | OTHER | Case Comprehensive Cancer Center | View | |
| 7537 | OTHER | CTEP | View | |
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062502 | NIH | None | https://reporter.nih.gov/quic… | View |