Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 10:04 PM
Study NCT ID:
NCT00519233
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2007-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.
Detailed Description:
Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.
Study Oversight
Has Oversight DMC:
True
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?: