A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Elesclomol Sodium
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Confirmed metastatic prostate cancer No more than one prior chemotherapy on which the disease progressed ECOG performance status of less than or equal to 2 Adequate bone marrow, renal and hepatic functions as defined in the protocol Neuropathy less than or equal to 2 Reliable venous access for frequent study drug infusions Exclusion Criteria Significant cardiovascular disease Known active brain metastases Subjects that have received treatment for other malignancies with in the past 5 years Other clinically significant uncontrolled conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort<br> | Drug: Elesclomol Sodium<br>* Chemotherapy agent<br>Drug: Docetaxel<br>* Chemotherapy agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Jan 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, cancer, metastatic, castration, refractory, elesclomol, sodium, docetaxel, prednisone