None listed
Conditions
Interventions
Group 1 Type of group
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Group name:Group 2 Type of group
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Advanced prostate cancer • At least 1 bone metastasis • Testosterone < 50 ng/dl • Prior treatment with docetaxel
Exclusion criteria
Exclusion criteria: • Brain metastasis • Autoimmune disease • Known HIV, Hep B, or Hep C infection • More than 2 prior systemic anticancer regimens for prostate cancer • Prior treatment on BMS CA180227 for prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive. Measure:Overall Survival (OS) Timepoints:Date of randomization to date of death ; Outcome name:The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates. Measure:Overall Survival Rate Timepoints:Date of randomization to date of death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:All PFS events were based on investigators assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date. Measure:Progression Free Survival (PFS) Timepoints:Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death ; Outcome name:The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period. Measure:Pain Response Timepoints:Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit ; Outcome name:The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date. Measure:Duration of Pain Response Timepoints:Day of initial pain response to day of completion of pain response or date of death ; Outcome name:AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with trea | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, United Kindgdom, United States
Contacts
Public ContactUrsula Noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed