Aveo, Astellas to launch new Tivo trial for renal cell carcinoma
Aveo Oncology and Astellas Pharma Inc. will launch a new clinical trial to gather more data for tivozanib, a new VEGF inhibitor for renal cell carcinoma, as a first-line treatment. Tivo has not yet been approved by the FDA to come to market. The trial, called TAURUS (TivozAnib Use veRsUs Sutent in advanced renal cell carcinoma (RCC): Patient Preference), will enroll about 160 patients at sites throughout the United States and Western Europe to compare the tolerability (side effects) of Tivo versus Sutent and which drug is preferred by patients after trying both.
“Patients and their healthcare providers are looking for anti-cancer agents that are more effective and better tolerated than existing therapeutic options,” said Bernard Escudier, M.D., principal investigator for TAURUS, “The TAURUS study will help us better understand how the side effect profiles of drugs affect patients’ treatment choices. The typical patient being treated for metastatic kidney cancer is middle-aged, active and is still in the work force and therefore the impact of side effects may be more important to them.”
TAURUS is a randomized (1:1), double-blind, crossover controlled, multi-center Phase 2 study. The primary objective of the study is to compare patient preference after receiving both tivozanib and sunitinib in sequence. Secondary objectives are to evaluate the incidence of treatment-emergent Grade 3/4 adverse events (AEs) and serious adverse events (SAEs); frequency of dose modifications; and quality of life in patients treated with tivozanib versus sunitinib.