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
3 other identifiers
interventional
13
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
Started Sep 2007
Shorter than P25 for phase_1 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedMay 2, 2014
April 1, 2014
2 years
August 20, 2007
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
3 Months
Secondary Outcomes (1)
The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.
3 Months
Study Arms (1)
1.AGS-1C4D4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient has hormone-refractory metastatic prostate cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Agensys, Inc.collaborator
Study Sites (2)
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 22020316BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Agensys, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 22, 2007
Study Start
September 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
May 2, 2014
Record last verified: 2014-04