Clinical Trial: Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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
Brief Summary: To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Detailed Summary:
Sponsor: Amgen
Current Primary Outcome: Percentage of Participants With Giant Cell Tumor Response [ Time Frame: From enrollment until 25 weeks ]
Original Primary Outcome: Response rate based on imaging (radiography) and/or tissue samples.
Current Secondary Outcome:
- 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.
- 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.
- 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).
- 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.
- 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.
Original Secondary Outcome: Safety profile of denosumab.
Information By: Amgen
Dates:
Date Received: November 2, 2006
Date Started: July 2006
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014