Pharmacyclics Completes Patient Enrollment in Smart Trial of Xcytrin

Pharmacyclics has announced that patient enrollment has been completed in its pivotal Phase III clinical trial of Xcytrin (motexafin gadolinium) injection for the potential treatment of lung cancer patients with brain metastases.

This randomized, controlled study, known as the SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial, has enrolled 550 patients at 94 leading medical centers in the U.S., Canada, Europe and Australia. The trial is designed to compare the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin.

The primary efficacy endpoint is time to neurologic progression as determined by a blinded events-review committee. Survival is also being assessed as a secondary endpoint of the trial.