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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elesclomol Sodium | Drug | Chemotherapy agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Maryland | 55905 | United States | ||
| University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| San Antonio |
| Texas |
| 78229 |
| United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |