Phase 2 N=37 Treatment

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

GCT · Giant Cell Tumor of Bone

Bottom Line

View on ClinicalTrials.gov: NCT00396279 ↗

Enrolled (actual)

Serious AEs

13.5%

Results posted

Mar 2014

Primary outcome: Primary: Percentage of Participants With Giant Cell Tumor Response — 85.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Denosumab (Biological); Calcium/Vitamin D (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Apr 2008

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	—	—

Summary

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

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.

View full record on ClinicalTrials.gov →

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.