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

Sponsor:	Astellas Pharma Inc
Collaborator:	Agensys, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00519233

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: AGS-1C4D4	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	September 2007
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1.AGS-1C4D4	Drug: AGS-1C4D4 IV

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519233

Locations

United States, Maryland

Baltimore, Maryland, United States, 21205
United States, New York

New York, New York, United States, 10065

Sponsors and Collaborators

Astellas Pharma Inc

Agensys, Inc.

Investigators

Study Director:

Central Contact

Agensys, Inc.

More Information

No publications provided

Responsible Party:	Vice President, Clinical Research & Development, Agensys, Inc.
ClinicalTrials.gov Identifier:	NCT00519233 History of Changes
Other Study ID Numbers:	2007001, MK4721-003, 2007_535
Study First Received:	August 20, 2007
Last Updated:	December 15, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

HRPC
Advanced hormone refractory prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012