Prostate Cancer
Conditions
Keywords
HRPC, Advanced hormone refractory prostate cancer
Brief summary
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.
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.
Interventions
DRUGAGS-1C4D4
IV
Sponsors
Agensys, Inc.
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. | 3 Months |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. | 3 Months |
Countries
United States
Outcome results
None listed