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news.Pharmacyclics has completed patient enrollment in its pivotal phase III clinical trial of Xcytrin injection for the potential treatment of lung cancer patients with brain metastases.
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This randomized controlled study, known as the SMART trial, has enrolled 550 patients at 94 leading medical centers in the US, 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 (motexafin gadolinium).
The trial’s 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. The trial is intended to demonstrate that Xcytrin, when added to WBRT, delays the time to neurologic progression in patients with brain metastases from lung cancer.
Lung cancer is the most common cause of brain metastases. Spread of lung cancer to the brain occurs early in the course of disease and is often diagnosed concurrently with the primary tumor. The results of recent studies have shown that brain metastases from lung cancer behave differently than other tumor types and are more amenable to treatment.
“Completion of enrollment in the SMART trial is a major milestone,” said Dr Richard Miller, president and CEO of Pharmacyclics. “With enrollment in the SMART trial completed, we will expand clinical development activities with Xcytrin in lung and other types of cancer.”