The Phase II clinical trial of ‘tivozanib’ is intended for patients with locally recurrent or metastatic triple negative breast cancer (TNBC).
AVEO, which was developing tivozanib in collaboration with Astellas Pharma, said enrollment in the trial had been slower than expected and did not improve following additional patient recruitment efforts.
AVEO chief medical officer William Slichenmyer said while the company believes in the potential benefits of tivozanib for patients with triple negative breast cancer, it has decided to discontinue the trial because of low patient accrual.
"We want to thank the study investigators and their patients who participated in the trial for their support," Slichenmyer said.
The BATON-BC trial, which began in December 2012, was testing the efficacy of tivozanib in combination with paclitaxel compared to placebo in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer who have received no more than one systemic therapy for advanced or metastatic breast cancer.
All committed expenses related to the randomized, double-blind, multicenter BATON-BC trial, were equally shared by AVEO and Astellas.
The data from a planned interim analysis of the Phase II trial of tivozanib in patients with colorectal cancer show that the trial is unlikely to meet the primary endpoint in the intent-to-treat patient population.