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news.A trial of the lung cancer drug Xyotax has been temporarily suspended by Cell Therapeutics in order to evaluate deaths that occurred during the trial.
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The Data Safety Monitoring Board (DSMB) has recommended that Cell Therapeutics suspends enrollment on the trial to assess differences in deaths observed between patients treated with Xyotax and those taking the standard cancer treatment paclitaxel.
Cell Therapeutics said that while most of the deaths were attributed to disease progression, more complete data would be required to analyze this difference.
In addition, following recommendations from the FDA, the company has reviewed current data and plans to amend the study while enrollment is suspended. The study will be amended to focus on the primary efficacy endpoint of survival in women with normal estrogen levels. These are a subset of patients that demonstrated the greatest survival benefit in earlier trials.
This study was initiated in December 2005. Cell Therapeutics expects to submit an amendment to the FDA under a special protocol assessment request. The company anticipates the change to the protocol will push the interim analysis of the trial back by at least six months.