Millennium, The Takeda Oncology Company, has initiated a Phase III trial for TAK-700 in patients with advanced prostate cancer. In preclinical studies, TAK-700, a selective, oral, non-steroidal androgen synthesis inhibitor, has been shown to selectively bind to and inhibit the enzyme 17,20 lyase1 in both the testes and adrenal glands.

The randomized, double-blind, multi-center, global Phase III study will examine TAK-700 with prednisone compared to placebo with prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Primary endpoints will be Overall Survival (OS) and Progression Free Survival (PFS).

“Our hope is that this trial will demonstrate strong levels of efficacy that address the unmet medical needs in advanced prostate cancer,” said Nancy Simonian, M.D., chief medical officer, Millennium. “The progress of TAK-700 into Phase III study further demonstrates commitment of Millennium and Takeda to advancing the treatment of prostate cancer.

A second Phase III trial2 of TAK-700 is planned for later this year and will compare TAK-700 plus prednisone versus placebo plus prednisone in patients with mCRPC that have progressed during or following docetaxel-based therapy.