Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma

Study Overview
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Brief Summary
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Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals. Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone. One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. 

Official Title
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A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Elesclomol (STA-4783)
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin ECOG performance status of <=2 Measurable disease according to modified RECIST Life expectancy of greater than 12 weeks LDH <= 2.0 x ULN Clinical lab values within protocol parameters. At least 18 years old and able and willing to provide informed consent to participate Exclusion Criteria: Previous cytotoxic chemotherapy treatment for melanoma Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma. Presence of brain metastases Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ Female subjects who are pregnant or nursing

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Elesclomol (STA-4783) in Combination With Paclitaxel | Drug: Elesclomol (STA-4783)<br>* 213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops<br>|
| Other: 2<br>Paclitaxel alone | Drug: Paclitaxel<br>* 80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | June 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | December 2009 | 
| Objective response rate |  | December 2009 | 
| Clinical benefit rate |  | December 2009 | 
| Duration of objective response |  | December 2009 | 
| Safety |  | December 2009 | 
| Pharmacokinetics |  | December 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, oncology, Stage IV Metastatic Melanoma