An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Inclusion Criteria

Inclusion criteria:

- Pathologically confirmed giant cell tumor of bone 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%

- 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

Exclusion criteria:

- 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

- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

- Active dental or jaw condition which requires oral surgery

- 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 7 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 7 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