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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elesclomol Sodium | Drug | Chemotherapy agent |
| |
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Jan 2011 | |
| To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel | Jan 2011 | |
| To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population | Jan 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer | Jan 2011 | |
| Evaluate OS | Jan 2011 | |
| To characterize the pharmacokinetics of elesclomol metabolites |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Coast Hematology/Oncology Medical Group | Fountain Valley | California | 92708 | United States | ||
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| Drug |
Chemotherapy agent |
|
| Jan 2011 |
| Mayo Clinic |
| Rochester |
| Maryland |
| 55905 |
| United States |
| Mid Dakota Clinic | Bismarck | North Dakota | 58501 | United States |
| University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development | San Antonio | Texas | 78229 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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