SOUTH SAN FRANCISO, Calif., Feb. 13 (UPI) -- Genentech said Monday it has suspended patient enrollment in the phase 3 study of its colon-cancer drug Avastin.
The company said it has halted enrollment in the AVANT study due to a higher rate of adverse events observed in patients taking the chemotherapy combination of Avastin and Xelox, compared to those taking Folfox and those on a Folfox/Avastin combination.
The Data Safety Monitoring Board will conduct a review of 60-day safety data, the company said.
The patients in the Xelox treatment arm of Genentech's study -- where the higher event rate was seen -- are taking capecitabine and oxaliplatin, while the Folfox patients are being given oxaliplatin, 5-FU and leucovorin, the firm said.
Genentech is testing the chemotherapy regimens in patients with early-stage colon cancer.
"Due to the rapid enrollment of patients in the AVANT study and the ongoing need to carefully monitor safety, we believe that the DSMB's recommendation to temporarily suspend enrollment in the study is the right thing to do for patients in order to enable a more detailed analysis of safety data," said Genentech Senior Vice President and Chief Medical Officer Hal Barron.
