Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2016-04-07
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Prednisone

Criteria

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