Study of Denosumab in Subjects With Giant Cell Tumor of Bone

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00680992
First received: May 15, 2008
Last updated: May 21, 2014
Last verified: May 2014
  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: December 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.
Other Name: Denosumab

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

CURRENTLY ENROLLMENT IS OPEN FOR ADOLESCENT SUBJECTS (12<= subject<18) ONLY

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

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 29 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional 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: May 21, 2014
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:
Bone Neoplasms
Giant Cell Tumors
Giant Cell Tumor of Bone
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue

ClinicalTrials.gov processed this record on August 28, 2014