A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria:
- Voluntary written consent
- Male patients 18 years or older
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Radiograph-documented metastatic disease
- Progressive disease
- Prior surgical castration or concurrent use of an agent for medical castration
- Either absence of pain or pain not requiring use of any opioid or narcotic analgesia
in the 2 weeks prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Even if surgically sterilized, patients must practice effective barrier contraception
during the entire study treatment and for 4 months after the last dose of study drug,
OR abstain from heterosexual intercourse
- Meet screening laboratory values as specified in protocol
- Stable medical condition
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:
- Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone
(GnRH) analogue
- Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
- Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all
others prior to first dose of study drug
- Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days
within 3 months prior to study
- Received prior chemotherapy for prostate cancer with exception of
neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease
that was completed 2 or more years prior to screening
- Exposure to radioisotope therapy within 4 weeks of receiving first dose of study
drug; exposure to external beam radiation within 2 weeks of start of screening until
receiving the first dose of study drug
- Documented central nervous system metastases
- Treatment with any investigational compound within 30 days prior to first dose of
study drug
- Current spinal cord compression, bilateral hydronephrosis or current bladder neck
outlet obstruction
- Diagnosis or treatment of another malignancy within 2 years preceding first dose of
study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- Uncontrolled cardiovascular condition as specified in study protocol
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C
- Unwilling or unable to comply with protocol
- Uncontrolled nausea, vomiting or diarrhea
- Known gastrointestinal disease or procedure that could interfere with oral absorption
or tolerance of orteronel