The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Chemotherapy agent
Mayo Clinic
Rochester, Maryland, United States
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
Time frame: Jan 2011
To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion
Time frame: Jan 2011
To inform dose selection for future study using a once-a-week schedule
Time frame: Jan 2011
To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable
Time frame: Jan 2011
To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense
Time frame: Jan 2011
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