Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

• Percentage of patients with serum testosterone levels reduced to ≤ 2 ng/dL [ Time Frame: Serum testosterone level in patients at screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle (upto 140 days) ] [ Designated as safety issue: No ]
• Serum testosterone level [ Time Frame: Change in the serum testosterone level at screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle (upto 140 days) ] [ Designated as safety issue: No ]
• PSA reduction ≥ 50% [ Time Frame: At screening, Cycle 1, 2, 3, 4 and 5- Day 1. Each cycle is a 28-day cycle. ] [ Designated as safety issue: No ]
• Pharmacodynamic effects of orteronel measured by endocrine markers plotted over time [ Time Frame: At screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle ] [ Designated as safety issue: No ]
• PK parameters for orteronel, including, but not limited to, Cmax, Area under Curve (AUC),Tmax, and the cumulative amount of unchanged drug excreted into the urine (Ae) in all treatment groups [ Time Frame: Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose ] [ Designated as safety issue: No ]
• Number of adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, vital sign measurements, physical examination findings, and electrocardiograms (ECGs) in all treatment groups [ Time Frame: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 2.5 years ] [ Designated as safety issue: Yes ]

This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

• Drug: orteronel 200mg/300mg

  Patients will be randomized to receive orteronel 200 mg BID or orteronel 300 mg BID

  Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.

• Drug: orteronel 200mg/400mg

  Patients will be randomized to receive orteronel 200 mg BID or orteronel 400 mg BID.

  Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.

• Drug: Placebo

  Patients will be randomized to receive placebo (Cycle 1 only).

  Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.

• Experimental: orteronel 200mg/300mg
  orteronel + Prednisone
  Intervention: Drug: orteronel 200mg/300mg
• Experimental: orteronel 200mg/400mg
  orteronel + Prednisone
  Intervention: Drug: orteronel 200mg/400mg
• Experimental: Placebo
  Placebo + Prednisone
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male patients 18 years or older
• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
• Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
• Prior surgical castration or concurrent use of an agent for medical castration (e.g. GnRH analogue)
• PSA ≥ 2 ng/mL at screening
• Progressive disease based on PSA and/or radiographic criteria

Exclusion Criteria:

• Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
• Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
• All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
• Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [eg, joint injection] are allowed).
• Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons