Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244881
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2005-10-25
Brief Title:
A Phase II Study of AZD2171 in Breast Cancer Stage IV 10006202
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of AZD2171 in Breast Cancer Stage IV 10006202
Status:
COMPLETED
Status Verified Date:
2013-11
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:
AZD2171 cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171
II Estimation of the objective response rate ORR CR PR among patients with refractory breast cancer receiving AZD2171
SECONDARY OBJECTIVES
I Estimation of the responsestable disease rate RSDR CR PR SD II Characterization of the toxicity associated with AZD2171 in this cohort of patients
III Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP
IV Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral AZD2171 once daily for 42 days Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 3 months
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study
I Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171
II Estimation of the objective response rate ORR CR PR among patients with refractory breast cancer receiving AZD2171
SECONDARY OBJECTIVES
I Estimation of the responsestable disease rate RSDR CR PR SD II Characterization of the toxicity associated with AZD2171 in this cohort of patients
III Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP
IV Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral AZD2171 once daily for 42 days Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 3 months
PROJECTED ACCRUAL A total of 26 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 |
|---|---|---|---|
| CDR0000445438 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062490 |
| 05-160 | None | None | None |
| U01CA062490 | NIH | None | None |