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CompletedNCT00519233Updated May 2, 2014

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

A Phase 1 interventional study of AGS-1C4D4 in Prostate Cancer, sponsored by Astellas Pharma Inc. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-02.

Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • HRPC
  • Advanced hormone refractory prostate cancer
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 13 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

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Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has hormone-refractory metastatic prostate cancer

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    1.AGS-1C4D4

    Drug: AGS-1C4D4

Interventions

06

What researchers measure

Primary outcomes

  1. Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.

    Time frame: 3 Months

Secondary outcomes

  1. The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.

    Time frame: 3 Months

07

Study locations

2 sites
  • Baltimore, Maryland 21205, United States
  • New York, New York 10065, United States
08

References and documents

Publications

  • 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. PubMed 22020316 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00519233
Lead sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.
Responsible party
Sponsor
First posted
Aug 22, 2007
Start date
Sep 2007
Primary completion
Sep 2009
Completion
Sep 2009
Last update
May 2, 2014

Study contacts

Central Contact
study director · Agensys, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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