A randomized, controlled, multi-center phase 2b PREDICT (Prostate Response Evaluating Docetaxel-Itraconazole Combination Therapy) trial to review our itraconazole in combination with the current standard of care docetaxel-prednisone chemotherapy. The main objective would be to evaluate the ability to delay the disease progression in high-risk men with metastatic castration-resistant prostate cancer (mCRPC).
Following FDA IND clearance, we will begin our Phase 2b trial planning. The design will have a primary endpoint of rPFS (radiographic progression-free survival) as 2nd line therapy in mCRPC. Potential for registration based on end of phase 2 IND protocol and statistical analysis plan and allowance to leverage itraconazole and itraconazole safety data with a confirmed 505(b)(2) regulatory pathway.
We will determine docetaxel dosing in conjunction with itraconazole and test our itraconazole against placebo in conjunction with docetaxel/prednisone therapy.