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news.AstraZeneca has stopped the Phase III Enthuse Study 15 evaluating zibotentan monotherapy in patients with non-metastatic castrate resistant prostate cancer (CRPC), as a review found that the trial was unlikely meet its primary efficacy endpoints.
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According to AstraZeneca, an early efficacy review by the Independent Data Monitoring Committee (IDMC) revealed that zibotentan monotherapy was unlikely to meet primary efficacy endpoints of progression free survival and overall survival.
As the review result indicates zibotentan monotherapy was unlikely to benefit patients with non-metastatic CRPC, the company has decided to stop the trial.
Study 15 is part of the Phase III clinical trial programme, Enthuse, which consists of three Phase III clinical studies designed to evaluate the efficacy and safety of zibotentan in extending survival in men with CRPC.
With the discontinuation of the monotherapy studies 14 and 15, there is one remaining study, Study 33, in the Enthuse monotherapy programme.
Study 33 will evaluate zibotentan plus chemotherapy, compared to chemotherapy alone, in men whose disease has metastasised and who have been prescribed treatment with chemotherapy Prostate Cancer and CRPC.