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Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.
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NuTide:121 is a global randomized Phase III study of Acelarin that will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia.
Details :
Acelarin, in combination with cisplatin, is currently being evaluated in a global Phase III study (NuTide:121) for the first-line treatment of patients with biliary tract cancer.
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The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug application (IND) for Acelarin.