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


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Cancer, GCT, Giant Cell Tumor of Bone, Benign GCT

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Trial Information

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


To determine how safe denosumab is in treating 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort.

Outcome Time Frame:

Duration of treatment and every 6 months for up to one year post treatment

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20062004

NCT ID:

NCT00680992

Start Date:

June 2008

Completion Date:

October 2014

Related Keywords:

  • Cancer
  • GCT
  • Giant Cell Tumor of Bone
  • Benign GCT
  • Giant Cell Tumor of Bone
  • Bone Neoplasms
  • Giant Cell Tumors
  • Giant Cell Tumor of Bone

Name

Location

Research SiteAnaheim, California  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina