Bone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate Cancer MedDRA version: 20.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classificatio
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
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 method 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 |
|---|---|
| Main Objective: To facilitate the access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale Safety Objective: To further assess the safety of denosumab for subjects who have participated in open label extensions of a denosumab advanced cancer phase 3 study ;Secondary Objective: Not applicable;Primary end point(s): Subject incidence of treatment-emergent adverse events and anti-denosumab antibodies;Timepoint(s) of evaluation of this end point: End of study (i.e. the time when the last subject is assessed or receives an intervention for evaluation in the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, European Union, France, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Panama, Peru, Poland, Russian Federation, South Africa, Spain, Ukraine
Contacts
Public ContactIHQ Medical Info – Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed