Health Condition 1: null- Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Health Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: Experimental: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks: Drug: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks until deno
Sponsors
Amgen Technology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject was previously enrolled in a denosumab phase three study and participated in the Open label Extension portion of that study. Subject or subjects legally acceptable representative has provided informed consent.
Exclusion criteria
Exclusion criteria: Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment. Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment. Subject has known sensitivity to any of the products to be administered during dosing. Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigators knowledge. Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and or to comply with all required study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject incidence of treatment-emergent adverse eventsTimepoint: [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: Yes ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject incidence of anti-denosumab antibodiesTimepoint: [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: No ] | — |
Countries
Argentina, Australia, Brazil, Chile, India, Israel, Panama, Peru, Russian Federation, South Africa, Ukraine, United Kingdom
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt. Ltd
Outcome results
None listed