Clinical trial NCT00396279: Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GCT
Giant Cell Tumor of Bone
Keywords: Giant Cell Tumor of Bone
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percentage of Participants With Giant Cell Tumor Response
timeFrame: From enrollment until 25 weeks
Secondary outcomes:
measure: 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
measure: 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
measure: 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.
measure: 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
measure: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Branstetter DG, Nelson SD, Manivel JC, Blay JY, Chawla S, Thomas DM, Jun S, Jacobs I. Denosumab induces tumor reduction and bone formation in patients with giant-cell tumor of bone. Clin Cancer Res. 2012 Aug 15;18(16):4415-24. doi: 10.1158/1078-0432.CCR-12-0578. Epub 2012 Jun 18.
citation: Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. doi: 10.1016/S1470-2045(10)70010-3. Epub 2010 Feb 10.
citation: Engellau J, Seeger L, Grimer R, Henshaw R, Gelderblom H, Choy E, Chawla S, Reichardt P, O'Neal M, Feng A, Jacobs I, Roberts ZJ, Braun A, Bach BA. Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone. World J Surg Oncol. 2018 Sep 19;16(1):191. doi: 10.1186/s12957-018-1478-3.