The trial has been temporarily suspended to allow a data safety monitoring board (DSMB) to conduct a review of 60-day safety data.
Suspension of the trial was recommended by the DSMB after an arm of the trial evaluating Avastin in combination with Xelox was associated with a higher incidence of adverse events than other arms of the trial.
A statement from Genentech said that a total of seven patients had died in this arm of the trial for reasons other than recurrent colon cancer. Of these, two patients died from cardiac complications, while the reasons behind the other three deaths remain unknown at this stage.
“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 Dr Hal Barron, Genentech’s senior vice president of development, and chief medical officer.
Since the trial began recruitment in December 2004, almost two thirds of the target number of 3,450 patients has been enrolled, and in January 2006 alone more than 250 patients were recruited.