AVEO Oncology and Astellas Pharma have started enrolling patients with advanced triple negative breast cancer not previously treated with any systemic therapy in a Phase II trial of Tivozanib.
The randomised, double-blind trial is the third under the Biomarker Assessment of Tivozanib in Oncology (BATON) clinical development programme, which also involves ongoing trials in advanced metastatic colorectal cancer and advanced RCC.
The multicentre study, led by AVEO, will enrol 147 patients and randomise them with either tivozanib or placebo in a 2:1 ratio.
Astellas Pharma global development medical oncology vice president Dr Stephen Eck said; "While tivozanib is currently under review with the FDA for advanced RCC, we’re committed to investigating the development of tivozanib beyond advanced RCC."
Progression-free survival (PFS) is the primary endpoint of the study while secondary objectives include evaluation of objective response rate, overall survival and safety.
An additional component of BATON-BC is the evaluation of biomarker relationships that may be predictive of clinical response to tivozanib in patients with triple negative breast cancer.
AVEO chief medical officer Dr William Slichenmyer said there are no approved targeted therapies to treat triple negative breast cancer at present.
"Biomarkers derived from AVEO’s Human Response Platform will be evaluated for potential use in identifying breast cancer patients who will be most likely to benefit from treatment with tivozanib," Slichenmyer said.