A new Phase 2 clinical trial of tesetaxel in men with castrate resistant advanced prostate cancer will be conducted through the Prostate Cancer Clinical Trials Consortium (PCCTC). Tesetaxel, an oral taxane which is in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.
The Prostate Cancer Clinical Trials Consortium (PCCTC), which is comprised of 13 leading academic centers focused on prostate cancer research. Memorial Sloan-Kettering Cancer Center, a member of the consortium, will act as the coordinating institution and is the first site to open for enrollment. Funding for the PCCTC is provided by the Department of Defense Prostate Cancer Research Program (DOD) and the Prostate Cancer Foundation.
The trial will evaluate two discrete populations: men who have advanced prostate cancer that is hormone/castrate-resistant who have not previously received chemotherapy; and men who have developed progressive disease after having received at least 3 cycles of docetaxel chemotherapy.
A two-stage design will be employed for each cohort, and a maximum of 96 subjects are projected to be accrued.