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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Chemotherapy agent
Chemotherapy agent
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States
Mayo Clinic
Rochester, Maryland, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States
To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
Time frame: Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
Time frame: Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
Time frame: Jan 2011
To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
Time frame: Jan 2011
Evaluate OS
Time frame: Jan 2011
To characterize the pharmacokinetics of elesclomol metabolites
Time frame: Jan 2011
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University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States