Status:
COMPLETED
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT01193257
Start Date
November 15 2010
End Date
February 29 2016
Last Update
December 19 2018
Active Locations (78)
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1
Anchorage, Alaska, United States, 99508
2
Fort Smith, Arkansas, United States, 72903
3
Fountain Valley, California, United States, 92708
4
Los Angeles, California, United States, 90025