Genentech suspends enrollment in Avastin trial

Avastin, which is already approved by the FDA as a first-line treatment for metastatic colorectal cancer, is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis.

Enrollment was discontinued in the trial following reports of five gastrointestinal (GI) perforations observed in the first 44 patients enrolled in the proposed 53-patient study.

The patients currently enrolled in the trial will be informed of the new safety information and, in consultation with their physician, may continue to receive protocol treatment with Avastin or elect to discontinue treatment.

“GI perforations are a known possible adverse event with Avastin; however, we chose to discontinue enrollment in this phase II study due to the observation of a higher rate seen in this study than in other trials of Avastin in ovarian cancer or other tumor types,” said Dr Hal Barron, Genentech’s senior vice president, development, and chief medical officer.

Dr Barron went on to say that the company is continuing with plans to study Avastin in earlier stage ovarian cancer based on activity seen to date and the unmet medical need for the condition. He also suggested that a possible reason for the higher incidence of GI perforations in this trial could be due to the fact that the patients enrolled had more advanced forms of the disease, and had received more prior chemotherapy than in previous clinical trials of the drug.