Abbott axes atrasentan trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott ends Phase III trial of atrasentan for end-stage prostate cancer after preliminary analysis fails to meet the primary endpoint of time to disease progression (a composite including the need for pain medication, chemotherapy or radiation and progression of cancer in bone). The selective endothelin-A receptor antagonist did yield improvements in development of bone pain as an adverse event, prostate-specific antigen levels and biochemical markers of skeletal progression. Study M00-211 enrolled 810 men with advanced metastatic hormone-refractory prostate cancer. Abbott will continue its second Phase III atrasentan trial, which is assessing the drug in men with less advanced, non-metastatic prostate cancer. Also continuing is a 200-patient Phase II study of men with rising PSA following prostate cancer surgery. The firm plans additional studies in earlier prostate cancer, renal cell carcinoma, ovarian, breast, brain, colorectal and non-small cell lung cancer