Posted by Michael Wonder on 16 Feb 2019
OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer
23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation.
OncoGenex Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the investigation of custirsen when administered in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer (CRPC) following prior treatment with a docetaxel-containing regimen.
The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate if custirsen, when combined with second-line chemotherapy cabazitaxel and prednisone, has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone. AFFINITY will enroll approximately 630 men and is expected to complete enrollment in the second half of 2014.
