NuCana Gets FDA Approval to Initiate Phase 3 Trial for Biliary Tract Cancer Therapeutic

NuCana (NCNA) said pre-market Friday that the US Food and Drug Administration cleared the company to conduct its phase three study of the investigational drug Acelarin combined with cisplatin for patients with previously untreated locally advanced or metastatic biliary tract cancer.

The trial will aim to determine Acelarin’s potential for improving the survival outcomes of patients with advanced cancer of the bile tract that connect the liver, gallbladder and small intestine. It will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia.

Nucana also said that it secured clearance from other regulatory agencies abroad.

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