Data Monitoring Committee (DMC) has recommended Celgene International to discontinue its Phase III Mainsail trial.
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The pivotal double-blinded trial was designed to assess the safety and efficacy of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prosta te cancer (CRPC).
The company decided to discontinue the trial based upon the findings that the combination of docetaxel and prednisone plus lenalidomide would not demonstrate a statistically significant treatment effect against the primary endpoint of overall survival versus docetaxel and prednisone plus placebo.