AGS-1C4D4 in Patients With Advanced Hormone Refractory Pr... | NCT00519233

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

NCT00519233

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 2, 2014Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Prostate Cancer

Interventions

AGS-1C4D4

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2014

Last Update Posted Date

May 2, 2014Estimated

Name	Class
Agensys, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Label	Type	Description	Intervention Names
1.AGS-1C4D4	Experimental		Drug: AGS-1C4D4

Name	Type	Description	Arm Group Labels	Other Names
AGS-1C4D4	Drug	IV	1.AGS-1C4D4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.		3 Months

Secondary Outcomes

Measure	Description	Time Frame
The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.		3 Months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Central Contact	Agensys, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Baltimore	Maryland	21205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22020316	Background	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Type	Description	Link
MK4721-003
2007_535