Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive 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 (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Key facts

Study ID

NCT01193244

Run by

Millennium Pharmaceuticals, Inc.

People needed

1560

Starts

2010-10-01

Expected to finish

2016-04-07

Last updated by the study team

2017-05-17

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Duarte, California, United States
• Study site — Highland, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Lansing, Michigan, United States
• Study site — Duluth, Minnesota, United States
• Study site — Corinth, Mississippi, United States
• Study site — Columbia, Missouri, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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