BioCentury
ARTICLE | Clinical News

Entinostat: Phase III start

March 31, 2014 7:00 AM UTC

Syndax said next month the ECOG-ACRIN Cancer Research Group will begin the double-blind, placebo-controlled, international Phase III E2112 trial to evaluate entinostat in combination with Aromasin exemstane in about 600 men and postmenopausal women with advanced estrogen receptor-positive, epidermal growth factor receptor 2 ( EGFR2; HER2; ErbB2; neu)-negative breast cancer who have progressed on a non-steroidal aromatase inhibitor. Syndax has an SPA from FDA for the trial, which is being conducted under the sponsorship of the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) (see BioCentury, Feb. 17). Entinostat has breakthrough therapy designation in the U.S. to treat locally recurrent or metastatic estrogen receptor-positive breast cancer when added to exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy. ...