Date: 2017-02-16
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Tracon Pharmaceuticals (USA - CA)
Product: TRC105
Action
mechanism: monoclonal antibody. TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation.
Disease: advanced angiosarcoma
Therapeutic area: Cancer - Oncology
Country: Austria, Belgium, France, Germany, Italy, Poland, Spain, UK, USA
Trial
details: The Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) is a one-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus single agent Votrient® in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously. The trial has an initial enrollment target of 124 patients and, based on an interim analysis, allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of potentially more responsive patients with cutaneous angiosarcoma. The primary endpoint is progression-free survival, with overall survival as a secondary endpoint. (NCT02979899)
Latest
news: * On February 16, 2017, Tracon Pharmaceuticals announced that it has initiated patient dosing in its Phase 3 TAPPAS (TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105.