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Study of zibotentan monotherapy in nonmetastatic prostate cancer halted
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AstraZeneca has announced that its phase 3 study of zibotentan monotherapy in patients with nonmetastatic castrate-resistant prostate cancer — ENTHUSE Study 15 — will be stopped after the results of an early efficacy review by an independent data monitoring committee. The review indicated that zibotentan monotherapy was unlikely to meet its primary efficacy endpoints of PFS and OS and, therefore, unlikely to benefit patients with this type of prostate cancer.
In September, the ENTHUSE Study 14, which evaluated zibotentan monotherapy, did not show a significant improvement in OS in patients with metastatic castrate-resistant prostate cancer. Based on this information, the company took an early view of the progress of the study, according to a press release.
Study 15 is part of the ENTHUSE phase 3 clinical trial program that was developed to assess the efficacy and safety of zibotentan in extending survival in men with castrate-resistant prostate cancer. The discontinuation of this study concludes the zibotentan program in this patient population. The full data from the study will be published in the future, according to the release.
The current ENTHUSE Study 33, a trial using zibotentan combined with standard chemotherapy in a more advanced metastatic castrate-resistant prostate cancer, will continue, and full results are expected in the second half of 2011.
Zibotentan — a novel once-daily tablet — works to block the endothelin pathway and slow tumor growth and the spread of cancer cells.
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