A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
Outcome Time Frame:
3 Months
Safety Issue:
No
Principal Investigator
Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Agensys, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
2007001
NCT ID:
NCT00519233
Start Date:
September 2007
Completion Date:
September 2009
Related Keywords:
- Prostate Cancer
- HRPC
- Advanced hormone refractory prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Baltimore, Maryland 21287 |
