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Aveo Oncology (Nasdaq: AVEO) of Cambridge and Astellas Pharma Inc. (TSE: 4503) of Tokyo  said they plan to start a new clinical trial in advanced renal cell carcinoma to establish more data for their investigational drug tivozanib when used as a first-line therapy in those cancer patients.

The study is designed to build upon safety profile demonstrated in TIVO-1 study, according to a statement from the companies. In February 2011, Aveo and Astellas entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib to treat a broad range of cancers.

The new trial, called TAURUS, will enroll about 160 patients at sites throughout the United States and Western Europe, the companies noted.

“With more treatment options available for patients living with cancer, it’s becoming increasingly critical to understand how patient preference is influenced by side effects and other related issues,” William Slichenmyer, M.D., and chief medical officer at Aveo, said in a written statement. “Following the positive findings from the Phase 3 TIVO-1 trial, the TAURUS study will allow us to further define the tolerability profile of tivozanib and understand the role that tivozanib could play in the treatment of first line advanced kidney cancer compared to a standard of care drug.”

According to Bernard Escudier, M.D., of Institute Gustave Roussy, who is principal investigator for the TAURUS study, patients and healthcare providers are looking for anti-cancer agents that are more effective and better tolerated than existing therapies. “The TAURUS study will help us better understand how the side effect profiles of drugs affect patients’ treatment choices,” he said in the companies’ press release. “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, double-blind, crossover controlled, multi-center Phase 2 study comparing tivozanib versus sunitinib in patients with advanced renal cell carcinoma who have received no prior systemic therapy. The primary objective of the study is to compare patient preference after receiving both tivozanib and sunitinib in sequence.

According to the companies, renal cell carcinoma is the ninth most commonly diagnosed cancer in men and women in the United States. The disease accounts more than 90 percent of all kidney cancers.

Aveo’s stock is up 2.21 percent in afternoon trading at $11.97.

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