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news.Genta, a biopharmaceutical company with a diversified cancer product portfolio, has initiated a Phase II clinical of oral taxane tesetaxel in patients with advanced prostate cancer.
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The study will assess tesetaxel as both first- and second-line chemotherapy.
The study will evaluate two discrete populations: men with hormone/castrate-resistant prostate cancer, who have not previously received chemotherapy; and men who have developed progressive disease after being treated with at least 3 cycles of docetaxel chemotherapy.
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 6 months. (6-month progression-free survival)
The study will be conducted through Prostate Cancer Clinical Trials Consortium (PCCTC), which is comprised of 13 leading academic centers focused on prostate cancer research, and will enroll 96 subjects.