Elesclomol trials suspended because of safety concerns

Synta Pharmaceuticals and GlaxoSmithKline have announced that they are suspending a phase 3 trial of elesclomol in chemotherapy-naïve patients with stage IV metastatic melanoma because of safety concerns.

Synta Pharmaceuticals and GlaxoSmithKline have announced that they are suspending a phase 3 trial of elesclomol in chemotherapy-naïve patients with stage IV metastatic melanoma because of safety concerns.

The trial (SYMMETRY) compared elesclomol in combination with paclitaxel versus paclitaxel alone. An analysis by an independent data monitoring committee demonstrated that a greater number of deaths occurred among patients treated with combination therapy than among patients treated with paclitaxel alone.

Because of these safety concerns, Synta has announced that other ongoing studies of elesclomol, including a trial of elesclomol plus docetaxel in patients with hormone-refractory metastatic prostate cancer and a dose-escalation trial of elesclomol monotherapy, will also be suspended pending further analysis of the SYMMETRY results.

Elesclomol was granted orphan drug designation in January 2008 and a fast-track designation in November 2006 for the treatment of metastatic melanoma.