Genta Incorporated has initiated a Phase II clinical of tesetaxel in patients with advanced prostate cancer to assess it as a first and second-line chemotherapy.
The study will evaluate two discrete populations, men with hormone/castrate-resistant prostate cancer and have not previously received chemotherapy, and men who have developed progressive disease after being treated with at least three cycles of docetaxel chemotherapy.
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A two-stage design will be used for each study arm.
The primary endpoint of the study is the estimation of the proportion of patients in each study arm whose disease has not progressed for at least six months.
The study will enrol 96 subjects and will be conducted through Prostate Cancer Clinical Trials Consortium, which is comprised of 13 leading academic centres focused on prostate cancer research.
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