Status:
COMPLETED
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Lead Sponsor:
Amgen
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with adva...
Eligibility Criteria
Inclusion
- Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
- Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2
- Adequate organ function
Exclusion
- Diagnosis of breast or prostate cancer
- Current or prior intravenous bisphosphonate administration
- Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
1779 Patients enrolled
Trial Details
Trial ID
NCT00330759
Start Date
June 1 2006
End Date
October 1 2011
Last Update
November 7 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.