Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02122172
Status:
TERMINATED
Last Update Posted:
2024-05-29
First Post:
2014-04-22
Brief Title:
Afatinib in Advanced Refractory Urothelial Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet accrual goal after several years
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 studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy Afatinib dimaleate may turn off the function of the epidermal growth factor EGF and human epidermal growth factor receptor 2 HER2 receptors which may slow the growth of cancer cells or cause some of the cells to die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the 3-month progression free survival PFS rate in metastatic urothelial cancer patients receiving afatinib afatinib dimaleate who have progressed despite prior platinum-based chemotherapy
SECONDARY OBJECTIVES
I To determine the overall response rate complete response CR partial response PR median progression free survival and overall survival for the same treated population
II To determine whether tumor epidermal growth factor receptor EGFR andor HER2 overexpression influences 3-month PFS in patients treated with afatinib
OUTLINE
Patients receive afatinib dimaleate orally PO once daily QD on days 1-42 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
I To determine the 3-month progression free survival PFS rate in metastatic urothelial cancer patients receiving afatinib afatinib dimaleate who have progressed despite prior platinum-based chemotherapy
SECONDARY OBJECTIVES
I To determine the overall response rate complete response CR partial response PR median progression free survival and overall survival for the same treated population
II To determine whether tumor epidermal growth factor receptor EGFR andor HER2 overexpression influences 3-month PFS in patients treated with afatinib
OUTLINE
Patients receive afatinib dimaleate orally PO once daily QD on days 1-42 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
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-2014-00859 | REGISTRY | None | None |
| IRB13-0540 | None | None | None |
| 13-0540 1200171 | OTHER | None | None |
| P30CA014599 | NIH | University of Chicago | httpsreporternihgovquickSearchP30CA014599 |