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

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT01193257

Run by

Millennium Pharmaceuticals, Inc.

People needed

1099

Starts

2010-11-15

Expected to finish

2016-02-29

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Fort Smith, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Westminster, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — East Syracuse, New York, United States
• Study site — Rochester, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Tualatin, Oregon, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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