Title
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Phase
Phase 1Lead Sponsor
AstellasStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Prostate CancerIntervention/Treatment
ags-1c4d4 ...Study Participants
13The 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.
IV
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