AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
- Registration Number
- NCT00519233
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1.AGS-1C4D4 AGS-1C4D4 -
- Primary Outcome Measures
Name Time Method Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. 3 Months
- Secondary Outcome Measures
Name Time Method The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. 3 Months