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NCT Number: NCT00519233

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGS-1C4D4

Drug

IV

Primary outcomes

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

    Time frame: 3 Months

Secondary outcomes

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

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Agensys, Inc.

Registry information

Official study title

A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 22, 2007
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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