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Digestive System Neoplasms
August 15, 2011
Genentech issued results from a phase II trial of telotristat etiprate for the treatment of carcinoid syndrome. The U.S-based, randomized, double-blind, placebo-controlled study enrolled 23 subjects with carcinoid syndrome who were refractory to currently available therapy. The subjects received either placebo or one of four doses of telotristat etiprate daily for 28 days. Five subjects in the telotristat etiprate arm achieved clinical responses characterized by reductions of at least 30% in the number of bowel movements per day for two weeks or more during the study. The difference between telotristat etiprate and placebo in bowel movement frequency ranged between 1.6 and 2.9 bowel movements per day across telotristat etiprate doses. In addition, six subjects receiving telotristat etiprate reported adequate relief of carcinoid symptoms at the end of the study and nine subjects showed a complete biochemical response, defined as a reduction of at least 50% in urinary 5-HIAA. Telotristat etiprate was well tolerated and adverse events were mild to moderate.