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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519233
First Posted: August 22, 2007
Last Update Posted: May 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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 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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00519233     History of Changes
Other Study ID Numbers: 2007001
MK4721-003
2007_535
First Submitted: August 20, 2007
First Posted: August 22, 2007
Last Update Posted: May 2, 2014
Last Verified: April 2014

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