Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma
Author(s) -
Steven O’Day,
Alexander M.M. Eggermont,
Vanna ChiarionSileni,
Richard Kefford,
JeanJacques Grob,
Laurent Mortier,
Caroline Robert,
Jacob Schachter,
Alessandro Testori,
Jacek Mackiewicz,
Philip Friedlander,
Claus Garbe,
Selma Ugurel,
Frances A. Collichio,
Wei Guo,
Joelle Lufkin,
Safi R. Bahcall,
Vojo Vukovic,
Axel Hauschild
Publication year - 2013
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.2012.44.5585
Subject(s) - medicine , paclitaxel , hazard ratio , oncology , tolerability , clinical endpoint , chemotherapy , proportional hazards model , randomized controlled trial , adverse effect , confidence interval
Elesclomol, an investigational first-in-class compound, induces oxidative stress, triggers mitochondrial-induced apoptosis in cancer cells, and shows synergy with taxanes in tumor models. Following completion of a phase II trial of elesclomol in combination with paclitaxel that met its primary end point of progression-free survival (PFS), this randomized, double-blind, controlled phase III study was conducted to confirm the efficacy and tolerability of elesclomol in combination with paclitaxel versus paclitaxel alone in patients with advanced melanoma.
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