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Study of Denosumab in Subjects With Giant Cell Tumor of Bone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00680992
First received: May 15, 2008
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
To determine how safe denosumab is in treating subjects with giant cell tumor of bone

Condition Intervention Phase
Cancer
GCT
Giant Cell Tumor of Bone
Benign GCT
Drug: Denosumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort. [ Time Frame: Duration of treatment and every 6 months for up to one year post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to disease progression for Cohort 1 [ Time Frame: Interval (in days) from the enrollment date to the date of disease progression ] [ Designated as safety issue: No ]
  • Proportion of subjects without any surgery at month 6 for Cohort 2 [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Evaluate denosumab pharmacokinetics in adolescent and adult subjects with GCTB (PK subset) [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 530
Study Start Date: June 2008
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
Drug: Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.

Detailed Description:
To determine how safe denosumab is in treating subjects with giant cell tumor of bone
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680992

  Hide Study Locations
Locations
United States, California
Research Site
Santa Monica, California, United States, 90403
Research Site
Stanford, California, United States, 94305
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20010
United States, Florida
Research Site
Gainesville, Florida, United States, 32607
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55455
United States, New York
Research Site
New York, New York, United States, 10003
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2250
Australia, Queensland
Research Site
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Research Site
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia, 6009
Austria
Research Site
Wien, Austria, 1090
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4A 3J1
France
Research Site
Lyon cedex 8, France, 69373
Research Site
Marseille cedex 05, France, 13385
Research Site
Villejuif cedex, France, 94805
Germany
Research Site
Bad Saarow, Germany, 15526
Research Site
Stuttgart, Germany, 70174
Italy
Research Site
Bologna, Italy, 40136
Research Site
Milano, Italy, 20133
Netherlands
Research Site
Leiden, Netherlands, 2333 ZA
Poland
Research Site
Warszawa, Poland, 01-211
Research Site
Warszawa, Poland, 02-781
Spain
Research Site
Palma de Mallorca, Baleares, Spain, 07010
Research Site
Barcelona, Cataluña, Spain, 08025
Research Site
Valencia, Comunidad Valenciana, Spain, 46026
Sweden
Research Site
Lund, Sweden, 221 85
United Kingdom
Research Site
Birmingham, United Kingdom, B31 2AP
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00680992     History of Changes
Other Study ID Numbers: 20062004 
Study First Received: May 15, 2008
Last Updated: April 20, 2016
Health Authority: Australia: Therapeutic Goods Administration
Canada: Health Canada
European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Giant Cell Tumor of Bone

Additional relevant MeSH terms:
Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016