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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGS-1C4D4
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring HRPC, Advanced hormone refractory prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1.AGS-1C4D4

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2007
Last Updated
April 30, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00519233
Brief Title
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Official Title
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
HRPC, Advanced hormone refractory prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.AGS-1C4D4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AGS-1C4D4
Intervention Description
IV
Primary Outcome Measure Information:
Title
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.
Time Frame
3 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Agensys, Inc.
Official's Role
Study Director
Facility Information:
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22020316
Citation
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.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=1036
Description
Link to Results on JAPIC

Learn more about this trial

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

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