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Completed

NCT Number: NCT00396279

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

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

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Key information

Conditions

GCT Giant Cell Tumor of Bone Giant Cell Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Denosumab

Biological

Administered by subcutaneous injection

Other names: Xgeva®

Calcium/Vitamin D

Dietary Supplement

Primary outcomes

  1. Percentage of Participants With Giant Cell Tumor Response

    Time frame: From enrollment until 25 weeks

    A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent < 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.

Secondary outcomes

  1. Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine

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

    Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.

  2. Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)

    Time frame: 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 C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.

  3. Serum Denosumab Trough Concentrations

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

    Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).

  4. Number of Participants With Adverse Events (AEs)

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

    An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.

  5. Number of Participants With Anti-Denosumab Antibodies

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

    Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects With Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Nov 6, 2006
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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