Bone metastases in subjects with advanced cancer
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study. -Subject or subject's 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 investigator's 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 |
|---|---|
| safety Subject incidence of treatment-emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| other Subject incidence of anti-denosumab antibodies | — |
Countries
Africa, Europe, Japan, South America
Outcome results
None listed