A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
- Registration Number
- NCT00827203
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort Elesclomol Sodium -
- Primary Outcome Measures
Name Time Method To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors Jan 2011 To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion Jan 2011
- Secondary Outcome Measures
Name Time Method To inform dose selection for future study using a once-a-week schedule Jan 2011 To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable 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 Jan 2011
Trial Locations
- Locations (3)
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