A Phase I Investigator sponsored clinical trial, led by Principal Investigator Dr.Andrew Armstrong at Duke University Hospital, US, has been announced for Active Biotech's prostate cancer project TASQ.
The primary objective for the CATCH trial (Cabazitaxel (Jevtana) And Tasquinimod in Men with Castration-Resistant Heavily pre-treated Prostate Cancer) is to determine the recommended dose of TASQ in combination with cabazitaxel based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC). Secondary objectives include efficacy as measured by progression free survival, and overall survival. The study will include about 30 CRPC patients. For further information about the study, please see www.clinicaltrials.gov.
In preclinical model systems of castrate-resistant prostate cancer, TASQ combined with taxane-based chemotherapy has been shown to further delay tumor progression.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III study of TASQ in patients with metastatic CRPC is ongoing. The aim of the study is to confirm TASQ's effect on the disease, with radiological PFS as the primary endpoint and overall survival as secondary endpoint. The study will include about 1,200 patients in more than 250 clinics.