An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone
Phase 2
Completed
- Conditions
- Giant Cell Tumor of BoneGiant Cell Tumor
- Registration Number
- NL-OMON47038
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment
Adults or skeletally mature adolecents >/<= 12 years of age
Measurable evidence of active disease within 1 year before study enrollment
For a complete list of all inclusion criteria please see protocol amendment 2 dated 22 oktober paragraph 4.1 page 24 en 25.
Exclusion Criteria
Currently receiving other GCT specific treatment
Concurrent bisphosphonate treatment
For a complete list of all exclusion criteria please see protocol amendment 2 dated 22 oktober 2009 paragraph 4.2 page 25 and 26.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety profile of denosumab characterized in terms of the type, frequency and<br /><br>severity of adverse events and laboratory abnormalities for each cohort.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- time to disease progression for cohort 1<br /><br>- proportion of subjects able to undergo limb or joint sparing surgical<br /><br>procedures or who do not require surgery</p><br>