Avastin trial recruitment suspended after patient deaths
pharmafile | February 16, 2006 | News story | Research and Development |
Roche has stopped recruiting colon cancer patients who have undergone surgery to a trial of Avastin after four suddenly died.
The phase III AVANT trial compares combinations of Avastin with different chemotherapy regimes and the deaths occurred in the patient group taking Avastin with Roche's chemotherapy drug Xeloda.
Patients already enrolled can continue on the trial with close monitoring, but no new patients will be taken on for two months, on the advice of the trial's independent Data Safety Monitoring Board.
With more than 200 patients being enrolled per month, the Board also had an issue with the speed at which patients were being recruited into the study saying "it could prevent adequate and timely intervention".
Ed Holdener, head of global development at Roche said: "Patient safety is of utmost importance to us. Speed of recruitment in the AVANT trial is exceeding expectations and safety should be carefully monitored."
Monitoring was especially important when Avastin was used as an adjuvant treatment, where its risk/benefit profile is different from that in its approved indication, he said.
Roche and its development partner Genentech are investigating Avastin in a number of other cancers including breast, lung, pancreatic cancer, ovarian cancer and renal cell carcinoma.
Avastin was first approved in the EU last January as a first line treatment of patients with metastatic carcinoma of the colon or rectum in combination with two types of chemotherapy.
It is the first treatment to inhibit angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. It does this by targeting the VEGF protein to choke off the blood supply to tumours and thus prevent it spreading.
Avastin is also currently being tested in combination with chemotherapy as an adjuvant treatment for early-stage colon cancer. More than 1,800 patients have been enrolled on the C-08 study and the company said it and any other ongoing Roche studies will continue as planned.
