Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Terminated
Synta Pharmaceuticals Corp.
Phase 3
"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. "
A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
Completed
Synta Pharmaceuticals Corp.
Phase 1
This aim of this study is to determine the safety and tolerability of elesclomol sodium at
escalating doses (ultimately identifying the maximum tolerated dose) when combined with a
fixed dose of docetaxel and concomitant prednisone. This study will also characterize the
pharmacokinetics of elesclomol and docetaxel.
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
Suspended
Synta Pharmaceuticals Corp.
Phase 1
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.
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