MADRID, August 11, 2016 /PRNewswire/ --
PharmaMar (MCE: PHM) announces that it has received the approval from the Independent Data Monitoring Committee (IDMC) to continue with the pivotal CORAIL study of PM1183 (lurbinectedin) in patients with platinum-resistant ovarian cancer up to the recruitment of the 420 patients established in the protocol.
This decision is based on the futility analysis of the first 210 patients (50% of the total 420), in which the safety and efficacy of PM1183 in this indication were evaluated.
CORAIL is a randomized Phase III Trial to evaluate the efficacy of PM1183 in comparison with topotecan or pegylated lyposomal doxorubicin, standard treatment of care for this pathology, in 420 patients. The primary endpoint of this study is to evaluate the Progression Free Survival (PFS), the secondary objectives being to analyze overall survival (OS), objective response rate along with the patients´ quality of life parameters.
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