NCT00522834

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Synta Pharmaceuticals Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"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. "

Conditions

• Melanoma

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-08-30
• Last updated: 2014-03-04

Locations

101 sites across 8 countries: United States, Australia, Canada, Germany, Puerto Rico, Romania, Spain, United Kingdom