TRACON Pharmaceuticals, Inc. Reaches Agreement with the U.S. Food and Drug Administration for Protocol Design, Clinical Endpoints and Statistical Analysis Approach for Phase 3 Study

On January 3, 2017, TRACON Pharmaceuticals, Inc. announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the cmpany's Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma. The company intends to conduct the Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) at sites in both the United States and Europe. This one-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus Votrient alone will initially enroll 124 patients. The trial features an adaptive design that, based on an interim analysis, can allow for sample size re-estimation up to a maximum of 200 patients, as well as possible enrichment of more responsive patients with cutaneous angiosarcoma. The primary endpoint of the trial is progression-free survival (PFS), with overall survival (OS) as a secondary endpoint.