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

Prostate Cancer Clinical Trial

Official title:

A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519233
• Other study ID #: 2007001
• Secondary ID: MK4721-0032007_5
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2007
• Last updated: April 30, 2014
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: April 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AGS-1C4D4
IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Agensys, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.		3 Months	No
Secondary	The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.		3 Months	No

External Links

•   Link to Results on JAPIC