Phase 2
Completed N=37
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
GCT · Giant cell tumor of bone
Source: ClinicalTrials.gov NCT00396279 ↗
Enrolled (actual)
37
Serious AEs
13.5%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Giant Cell Tumor Response — 85.7 percentage of participants
Summary
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Giant Cell Tumor Response |
85.7 | — |
| SECONDARY Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine |
-70.9; -77.0; -60.0; -59.5; -64.5; -56.4 | — |
| SECONDARY Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen) |
-78.9; -79.8; -80.4; -82.6; -82.0; -79.5 | — |
| SECONDARY Serum Denosumab Trough Concentrations |
NA; 19000; 31600; 36400; 27500; 23300 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
33; 5; 1; 2; 3; 5 | — |
| SECONDARY Number of Participants With Anti-Denosumab Antibodies |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adults, 18 years and older
- Histologically confirmed and measurable giant cell tumor (GCT)
- Recurrent GCT confirmed by radiology or unresectable GCT
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
- Pateints for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab
- Radiation to affected region within 28 days before enrollment to study
- Known diagnosis of osteosarcoma or brown tumor of bone
- Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
- Concurrent treatment with bisphosphonates, calcitonin, or interferon.
Other criteria also apply.
Data sourced from ClinicalTrials.gov (NCT00396279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.