A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors

Conditions
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Metastatic Solid Tumors

Intervention / Treatment
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* Drug: Elesclomol Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males and females at least 18 years of age Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy Acceptable organ and marrow function during the Screening Period as defined by the protocol. Reliable venous access suitable for weekly study drug infusions Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria Pregnant or breast-feeding women Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study Primary brain tumors or active brain metastases Treatment with chronic immunosuppressants Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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>|

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 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

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, metastatic, Elesclomol Sodium, tumor, Advanced solid tumors that are metastatic and unresectable