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

This study has been completed.
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: August 20, 2007
Last updated: April 30, 2014
Last verified: April 2014
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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:

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 ]

Secondary Outcome Measures:
  • The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. [ Time Frame: 3 Months ]

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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00519233

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.
Study Director: Central Contact Agensys, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00519233     History of Changes
Other Study ID Numbers: 2007001
Study First Received: August 20, 2007
Last Updated: April 30, 2014

Keywords provided by Astellas Pharma Inc:
Advanced hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 17, 2017