Metastatic castrate-resistant prostate cancer MedDRA version: 14.0 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection
INN or Proposed INN: denosumab
CAS Number: 615258-40-7
Current Sponsor code: AMG 162
Other descriptive name: I
Sponsors
Amgen Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Men greater than or equal to 18 years of age with histologically-confirmed prostate cancer. -Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis. -Documented failure of at least one hormonal therapy as evidenced by a rising PSA (ie, 3 consecutive determinations, taken at least 2 weeks apart from one another. The third measurement must be greater than or equal to 0.4 ng/mL and taken within 8 weeks prior to randomization). -Serum testosterone level of =65 years) yes F.1.3.1 Number of subjects for this age range 1663
Exclusion criteria
Exclusion criteria: -Current or prior IV bisphosphonate administration for any reason -Current or prior oral bisphosphonate administration for the treatment of bone metastases -Planned radiation therapy or surgery to bone -Prior administration of denosumab -Known brain metastasis -Life expectancy less than 6 months -Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw -Active dental or jaw condition that requires oral surgery -Non-healed dental/oral surgery -Planned invasive dental procedure(s) for the course of the study -Evidence of any of the following conditions per subject self report or medical chart review: 1. Known history of second malignancy within the past 3 years, except for basal cell carcinoma 2. Known infection with human immunodeficiency virus 3. Active infection with hepatitis B or hepatitis C virus -Any disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results -Thirty days or less since receiving an investigational product or device (ie, does not have marketing authorization) in another clinical trial -Subject with reproductive potential who will not agree to use effective contraception (as defined by the investigator or designee) -Known sensitivity to any of the products to be administered during dosing (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with hormone-refractory prostate cancer and bone metastases. SRE is defined as pathological fracture (vertebral or nonvertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.;Secondary Objective: -To determine if denosumab is superior to zoledronic acid with respect to first on-study SRE -To determine if denosumab is superior to zoledronic acid with respect to first-and-subsequent on-study SRE (multiple event analysis) - To assess the safety and tolerability of denosumab compared with zoledronic acid ;Primary end point(s): Time to the first on-study SRE (non-inferiority). SRE is an aggregate endpoint that includes pathologic fracture(s) (vertebral or non vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. ;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 745 subjects have experienced an on-study SRE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to the first on-study SRE (superiority) - Time to first-and-subsequent on-study SRE (superiority) - Subject incidence of treatment-emergent adverse events - Changes in laboratory values - Incidence of anti-denosumab antibody (binding and neutralizing) formation;Timepoint(s) of evaluation of this end point: Analysis cut-off date is event-driven (i.e. when approximately 745 subjects have experienced an on-study SRE) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Costa Rica, Czech Republic, Denmark, Estonia, European Union, Finland, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Panama, Peru, Russian Federation, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info – Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed