Exelixis suspended new patient enrollment in the ongoing XL999 clinical trials in November 2006, after cardiovascular events were observed. The FDA subsequently placed the clinical program on partial clinical hold in December, and the company said that there are no plans to restart these trials.
However, the FDA has now accepted a new trial protocol, and the study will evaluate XL999 in patients with non-small cell lung cancer (NSCLC) who have failed at least one previous therapy. The trial will have a dose-escalation format starting at 0.4 mg/kg dosed weekly, while monitoring patients for potential cardiovascular events.
“We have worked closely with the FDA to reinitiate the clinical development of XL999 and believe that the approved protocol will enable us to assess both safety and preliminary anti-tumor activity of the compound in patients with NSCLC,” said George Scangos, president and CEO of Exelixis.
The company expects to begin patient enrollment in the summer.