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

• Status: Completed
• Trial end date: 2016-02-29
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy

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

Details

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

Criteria

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria:

• Voluntary written consent

• Male 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

• Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

• Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse

• Screening laboratory values as specified in protocol

• Stable medical condition

• Life expectancy of 6 months or more

• Participants who have had up to 2 prior chemotherapy treatments are eligible to participate

Exclusion Criteria:

Participants 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

• Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug

• Radioisotope therapy or external beam radiation therapy within 4 weeks of 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 (Participants who are in long-term follow-up following active treatment in other trials are eligible)

• 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

• Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel

• Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy

• Prostate cancer confined to just the prostrate bed or immediate adjacent tissue