RedHill Biopharma announced that the ongoing single-arm Phase IIa study with orally-administered Yeliva for the treatment of advanced cholangiocarcinoma has achieved its pre-specified efficacy goal for the first stage of the two-stage study design, and as a result, the study will continue to its second stage, enrolling the full cohort of 39 evaluable patients.The primary efficacy endpoint of the study is defined as either partial or complete response, or stable disease at four months treatment with Yeliva. Enrollment of all subjects is expected to be completed by mid-2019. The single-arm Phase IIa study is evaluating the activity of Yeliva as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma. All subjects enrolled in the study have received up to two lines of other systemic therapy for advanced disease. The study is being conducted at renowned clinical institutions in the U.S.
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