Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01582191
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2012-04-18
Brief Title:
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase 1 Trial of Vandetanib a Multi-Kinase Inhibitor of EGFR VEGFR and RET Inhibitor in Combination With Everolimus an mTOR Inhibitor in Advanced Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 studies the side effects and best dose of vandetanib and everolimus when given together in treating patients with cancer that has spread to other places in the body Vandetanib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD or highest dose level and the dose-limiting toxicity DLT of vandetanib a multi-kinase inhibitor of epidermal growth factor receptor EGFR vascular endothelial growth factor receptor VEGFR and ret proto-oncogene RET inhibitor when used in combination with everolimus a mammalian target of rapamycin mTOR inhibitor in advanced cancer
II Preliminary descriptive assessment of the anti-tumor efficacy of the combination
III Preliminary optional assessment of the pharmacokinetic pharmacodynamic markers of target inhibition and correlates of response
OUTLINE This is a dose-escalation study
Patients receive vandetanib orally PO once daily QD and everolimus PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up between 14-28 days at the discretion of the treating physician
I To determine the maximum tolerated dose MTD or highest dose level and the dose-limiting toxicity DLT of vandetanib a multi-kinase inhibitor of epidermal growth factor receptor EGFR vascular endothelial growth factor receptor VEGFR and ret proto-oncogene RET inhibitor when used in combination with everolimus a mammalian target of rapamycin mTOR inhibitor in advanced cancer
II Preliminary descriptive assessment of the anti-tumor efficacy of the combination
III Preliminary optional assessment of the pharmacokinetic pharmacodynamic markers of target inhibition and correlates of response
OUTLINE This is a dose-escalation study
Patients receive vandetanib orally PO once daily QD and everolimus PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up between 14-28 days at the discretion of the treating physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2012-00782 | REGISTRY | None | None |
| 0953 | None | None | None |
| 2011-0953 | OTHER | M D Anderson Cancer Center | None |