A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
| Registry | NCT00519233 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 13 (Actual) |
| Sponsor | Astellas Pharma Inc (Industry); collaborators: Agensys, Inc. |
| Conditions | Prostate Cancer |
| Interventions | AGS-1C4D4 (Drug) |
| Dates | start 2007-09-01, primary completion 2009-09-01, completion 2009-09-01, first posted 2007-08-22, last updated 2014-05-02 |
| Locations | 2 sites in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 1.AGS-1C4D4 | Experimental | Drug: AGS-1C4D4 |
Sex: Male, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Baltimore, Maryland | United States | ||
| New York, New York | United States |