AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00519233
First received: August 20, 2007
Last updated: April 30, 2014
Last verified: April 2014

August 20, 2007
April 30, 2014
September 2007
September 2009   (final data collection date for primary outcome measure)
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00519233 on ClinicalTrials.gov Archive Site
The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: AGS-1C4D4
IV
Experimental: 1.AGS-1C4D4
Intervention: Drug: AGS-1C4D4
Antonarakis ES, Carducci MA, Eisenberger MA, Denmeade SR, Slovin SF, Jelaca-Maxwell K, Vincent ME, Scher HI, Morris MJ. Phase I rapid dose-escalation study of AGS-1C4D4, a human anti-PSCA (prostate stem cell antigen) monoclonal antibody, in patients with castration-resistant prostate cancer: a PCCTC trial. Cancer Chemother Pharmacol. 2012 Mar;69(3):763-71. doi: 10.1007/s00280-011-1759-9. Epub 2011 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has hormone-refractory metastatic prostate cancer

Exclusion Criteria:

  • Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects
  • Patient is currently participating or has participated in an investigational study within the past 30 days
  • Patient has illness or circumstance that could limit compliance with the study requirements
  • Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year
  • Patient has Hepatitis B or C
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519233
2007001, MK4721-003, 2007_535
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Agensys, Inc.
Study Director: Central Contact Agensys, Inc.
Astellas Pharma Inc
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP