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news.Genta has dosed first patient with advanced gastric cancer in the new randomized double-blind, placebo-controlled trial of tesetaxel, known as TESEGAST.
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The trial which will be conducted at approximately 40 sites worldwide, including the US, Western Europe, and Asia, is expected to enroll 260 patients.
The overall survival is the primary endpoint of the study and the secondary endpoints consist of overall response, progression-free survival and safety.
Genta president and chief medical officer Loretta M Itri said, "TESEGAST builds on our experience in two Phase 2a studies and more than 80 patients treated with tesetaxel as 2nd-line therapy for advanced gastric cancer."
The company expects to take approximately 12-15 months, with approximately nine months of follow-up after the last patient is randomized.
MD Anderson Cancer Center professor of medicine, principal Investigator for TESEGAST Jaffer Ajani said, "Our Phase 2 experience as 2nd-line therapy for patients with advanced gastric cancer showed that the response rate from tesetaxel has equaled or exceeded that of docetaxel in this patient population."