Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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. "