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Study Complete
Sponsor ID
20040215

Safety and Efficacy Study of Denosumab in Patients with Recurrent or Unresectable Giant Cell Tumor of Bone

Sponsor ID
20040215
Clinicaltrials.gov ID
NCT00396279
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
37
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants with Giant Cell Tumor Response

Timeframe: From enrollment until 25 weeks

Secondary Outcome Measures

Percent Change from Baseline in Urinary N-telopeptide corrected for urine creatinine

Timeframe: Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81

Percent Change from Baseline in Serum C-terminus peptide (of type 1 collagen)

Timeframe: Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81

Serum Denosumab Trough Concentrations

Timeframe: Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.

Number of participants with Adverse Events (AEs)

Timeframe: From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months

Number of participants with Anti-Denosumab Antibodies

Timeframe: From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Giant Cell Tumor
    • Sex
    All
    Trial Dates
    Jul 2006 - Apr 2008
    Inclusion and Exclusion 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.