None listed
Conditions
Interventions
Group 1 Type of group
Patients will receive 400 mg orteronel twice a day until disease progression is documented.
Group name:Group 2 Type of group
Patients will receive corresponding placebo tablets twice a day until disease progression is documented.
Sponsors
Millennium Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. Measure:Overall Survival Timepoints:Baseline until death (approximately up to 4.5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria. Measure:Radiographic Progression-free Survival (rPFS) Timepoints:Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) ; Outcome name:The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline. Measure:Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 Timepoints:Week 12 ; Outcome name:Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. Measure:Percentage of Participants With Pain Response at Week 12 Timepoints:Week 12 ; Outcome name:ECOG assessed participants performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically s | — |
Countries
Australia, Belgium, Canada, Czech Republic, Estonia, Finland, France, Greece, Hungaria, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed