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

• Overall Survival [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
• Objective response rate [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
• Clinical benefit rate [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
• Duration of objective response [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
• Safety [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
• Pharmacokinetics [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

• Overall Survival
• Objective response rate
• Clinical benefit rate
• Duration of objective response
• Safety
• Pharmacokinetics

"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. "

• Drug: Elesclomol (STA-4783)
  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
  Other Name: Elesclomol (STA-4783)
• Drug: Paclitaxel
  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

• Active Comparator: 1
  Elesclomol (STA-4783) in Combination With Paclitaxel
  Intervention: Drug: Elesclomol (STA-4783)
• 2
  Paclitaxel alone
  Intervention: Drug: Paclitaxel

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