Status:
COMPLETED
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive 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 (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemothera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2016
Estimated Enrollment :
1560 Patients enrolled
Trial Details
Trial ID
NCT01193244
Start Date
October 1 2010
End Date
April 7 2016
Last Update
May 17 2017
Active Locations (240)
Enter a location and click search to find clinical trials sorted by distance.
1
Anchorage, Alaska, United States
2
Tucson, Arizona, United States
3
Duarte, California, United States
4
Highland, California, United States