A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Confirmed metastatic prostate cancer No more than one prior chemotherapy on which the disease progressed ECOG performance status of less than or equal to 2 Adequate bone marrow, renal and hepatic functions as defined in the protocol Neuropathy less than or equal to 2 Reliable venous access for frequent study drug infusions
Exclusion Criteria
Significant cardiovascular disease Known active brain metastases Subjects that have received treatment for other malignancies with in the past 5 years Other clinically significant uncontrolled conditions