The FDA has signed off NuCana’s (NASDAQ:NCNA)
IND for its Phase III study (NuTide:121) of Acelarin (NUC-1031) in
combination with cisplatin for patients with previously untreated
locally advanced or metastatic biliary tract cancer.
The study will enroll up to 828 patients. The primary objectives are Overall Survival (OS) and Objective Response Rate (ORR).
Three interim analyses, including two designed to
support accelerated approval, are planned as part of the Phase III study
protocol in addition to the final analysis.
https://seekingalpha.com/news/3509620-fda-oks-nucanas-late-stage-nucminus-1031-study
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