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Find Clinical Drug Pipeline Developments & Deals for Acelarin
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.
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.
The study compared a 500mg/m2 dose of Acelarin versus a 750mg/m2 dose of Acelarin in patients who were heavily pre-treated (at least 3 prior lines of chemotherapy).
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.
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.