According to a media release earlier today, Millennium and its parent company Takeda Pharmaceutical have initiated a randomized, double-blind, multi-center, Phase III clinical trial of TAK-700 (to be known in the future as Ortoronel) for the treatment of patients with chemotherapy-naïve, metastatic, castration-resistant prostate cancer (mCRPC).
This study will randomize eligible patients to TAK-700 + prednisone or to placebo + prednisone. Primary endpoints for this study are overall survival (OS) and radiographic progression-free survival (PFS). Additional information about this trial is available on the ClinicalTrials.gov web site.
TAK-700 is a selective, oral, non-steroidal androgen synthesis inhibitor. In preclinical studies TAK-700 has been shown to bind to and inhibit the enzyme 17,20-lyase 1 in the testes and in the adrenal glands.
Later in the year, Millennium and Takeda plan to open enrollment of patients with docetaxel-refractory mCRPC into a second Phase III clinical trial of TAK-700. This second Phase III trial will also randomize patients to TAK-700 + prednisone or to placebo + prednisone.
Three other Phase II clinical trials of TAK-700 are still enrolling patients — one in men with non-metastatic CRPC and a rising PSA and a second in men with mCRPC.
Some time in the not too distant future, The “New” Prostate Cancer InfoLink expects Millennium to initiate at least one Phase III clinical trial in men with non-metastatic CRPC.
Along with abiraterone acetate and MDV3100, TAK-700 is another new pharmaceutical expected to add to the spectrum of pharmacotherapeutic agents that can offer potential survival benefits for men who are no longer responding to traditional hormone therapy and/or chemotherapy.