Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Completed · Phase 2

Conditions studied: Cancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors

In brief

To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

Key facts

Study ID: NCT00680992
Run by: Amgen
People needed: 535
Starts: 2008-09-09
Expected to finish: 2018-05-17
Last updated by the study team: 2022-09-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pathologically confirmed GCTB within 1 year before study enrollment
Measurable evidence of active disease within 1 year before study enrollment
Subjects with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
Karnofsky performance status equal or greater than 50% (ie, Eastern Cooperative Oncology Group status 0, 1, or 2)
Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate]) equal or greater than 12 years of age
Skeletally mature adolescents must weigh at least 45 kg
Before any study-specific procedure is performed, the appropriate written informed consent must be obtained

You may not qualify if…

Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
Concurrent bisphosphonate treatment
Known or suspected current diagnosis of underlying malignancy including high grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
Known or suspected current diagnosis of non GCTB giant cell-rich tumors
Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease
Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Active dental or jaw condition which requires oral surgery, including tooth extraction
Non-healed dental/oral surgery
Planned invasive dental procedure for the course of the study
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
Subject has known sensitivity to any of the products to be administered during dosing
Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Where it is running

Research Site — Santa Monica, California, United States
Research Site — Stanford, California, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Gainesville, Florida, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — New York, New York, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Greenville, South Carolina, United States
Research Site — Camperdown, New South Wales, Australia
Research Site — Woolloongabba, Queensland, Australia
Research Site — East Melbourne, Victoria, Australia
Research Site — Nedlands, Western Australia, Australia
Research Site — Vienna, Austria
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Lyon, France
Research Site — Marseille, France
Research Site — Villejuif, France
Research Site — Bad Saarow, Germany
Research Site — Stuttgart, Germany
Research Site — Bologna, Italy
Research Site — Milan, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.