Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243074
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2005-10-20
Brief Title:
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 NSC-732208 in Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2014-02
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 study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery AZD2171 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective confirmed complete and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171
SECONDARY OBJECTIVES
I Determine the clinical benefit in terms of objective response and stable disease rates in patients treated with this drug
II Determine the 1-year median overall survival and progression-free survival in patients treated with this drug
III Determine the frequency and severity of toxic effects in patients treated with this drug
IV Correlate preliminarily pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug
V Correlate preliminarily circulating endothelial cells with clinical outcomes in patients treated with this drug
VI Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients
OUTLINE
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 periodically for up to 5 years from study entry
I Determine the objective confirmed complete and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171
SECONDARY OBJECTIVES
I Determine the clinical benefit in terms of objective response and stable disease rates in patients treated with this drug
II Determine the 1-year median overall survival and progression-free survival in patients treated with this drug
III Determine the frequency and severity of toxic effects in patients treated with this drug
IV Correlate preliminarily pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug
V Correlate preliminarily circulating endothelial cells with clinical outcomes in patients treated with this drug
VI Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients
OUTLINE
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 periodically for up to 5 years from study entry
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 |
|---|---|---|---|
| CDR0000446178 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0509 | None | None | None |
| U10CA032102 | NIH | None | None |