Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243061
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2005-10-20
Brief Title:
AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2018-07
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 II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the objective tumor response rate of AZD2171 administered to patients with recurrent or metastatic malignant melanoma
II To assess the toxicity median survival time 1-year survival rate response or stable disease duration time to disease progression and clinical benefit response of AZD2171 administered to patients with recurrent or metastatic malignant melanoma
III To measure baseline and post-treatment levels of angiogenic growth factors and receptors as well as circulating endothelial cells and to explore the relationship between these potential correlative endpoints and clinical outcome
IV To assess changes in blood flow and vessel permeability using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI pre- and post-treatment and to explore the relationship between these potential imaging endpoints and clinical outcome
V To look for polymorphisms of kdrflk-1 and other genes in this pathway by performing pharmacogenetic analysis of pbmcs and correlate genotype with VEGF levels and response to therapy
OUTLINE This is an open-label multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
I To assess the objective tumor response rate of AZD2171 administered to patients with recurrent or metastatic malignant melanoma
II To assess the toxicity median survival time 1-year survival rate response or stable disease duration time to disease progression and clinical benefit response of AZD2171 administered to patients with recurrent or metastatic malignant melanoma
III To measure baseline and post-treatment levels of angiogenic growth factors and receptors as well as circulating endothelial cells and to explore the relationship between these potential correlative endpoints and clinical outcome
IV To assess changes in blood flow and vessel permeability using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI pre- and post-treatment and to explore the relationship between these potential imaging endpoints and clinical outcome
V To look for polymorphisms of kdrflk-1 and other genes in this pathway by performing pharmacogenetic analysis of pbmcs and correlate genotype with VEGF levels and response to therapy
OUTLINE This is an open-label multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
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 |
|---|---|---|---|
| N01CM62201 | NIH | N01CM62203 | httpsreporternihgovquickSearchN01CM62201 |
| PHL-038 | OTHER_GRANT | None | None |
| N01CM62203 | NIH | None | None |