Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Amgen

Status and phase

Completed

Phase 2

Conditions

Giant Cell Tumor of Bone

Cancer

Benign Giant Cell Tumors

Giant Cell Tumors

Treatments

Drug: Denosumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00680992

20062004

Details and patient eligibility

About

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

Full description

To determine how safe denosumab is in treating subjects with GCTB

Enrollment

535 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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 (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