Clinical Trial: AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
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 Summary: 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.
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ]
Original Primary Outcome:
Current Secondary Outcome: The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ]
Original Secondary Outcome:
Information By: Astellas Pharma Inc
Dates:
Date Received: August 20, 2007
Date Started: September 2007
Date Completion:
Last Updated: April 30, 2014
Last Verified: April 2014