Synta initiates Phase III trial for elesclomol in melanoma

This Phase III trial known as SYMMETRY (synta metastatic melanoma elesclomol trial), is enrolling patients with stage IV metastatic melanoma who have not received prior chemotherapy but who may have already been treated with non-chemotherapeutic agents such as biologics. Approximately 630 patients will be enrolled in the blinded, randomized, controlled study, which will be conducted at approximately 150 centers worldwide.

Patients will be randomized (1:1) to elesclomol (213 mg/m2) plus paclitaxel (80 mg/m2) or paclitaxel alone (80 mg/m2) and will receive three weekly treatments and one week without treatment per each four week cycle. If tolerated, treatment will continue until disease progression.

Patients will be stratified according to LDH levels, M-grade status and prior treatment history. Responses will be assessed using standard RECIST criteria at baseline and at a minimum every other cycle, with radiology scans being assessed by independent, blinded, reviewers at a central site.

Safi Bahcall, president and CEO, Synta, said: “Initiating the SYMMETRY trial is an important step in confirming the benefit to patients observed in our Phase IIb trial and creating a new treatment option for this disease.”