A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects with Advanced Prostate Cancer.
This is an open-label, multi-center, dose escalation study examining the safety and pharmacogenics of ASG-%ME monotherapy in subjects with advanced prostate cancer whose disease has progressed despite hormonal therapy. Based upon the preclinical in vivo efficacy data, treatment with ASG-5ME as a single agent may result in more effective subject outcome.
Histologically-confirmed castration resistant protate cancer after local therapy. Good hematological status, kidney and liver function within normal limits. Must remain on a stable dose of LHRH. Must follow study requirements. No brain metastasis or other primary tumors, no concurrent use of Prenisone of greater than 20 mg/day, cannot have peripheral neuropathy greater than grade 2.
AGS-5ME is an IV infusion over 30 minutes given every 21 days. This is a dose escalation study, and the patient will be dosed per that particular cohort. When a toxicity is reached, this will be the MTD for this study. The patient will have his disease evaluated after every 12 weeks (4 cycles), and will remain on study until disease progression, or the patient requests to come off study, or there are untolerable toxicities.
12/10/2013 04:02 AM