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Safety Study of Denosumab in Subjects With Recurrent or Unresectable 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: November 19, 2012
Last verified: November 2012
History of Changes

May 15, 2008
November 19, 2012
June 2008
September 2014   (final data collection date for primary outcome measure)
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 ]
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 6 months post treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00680992 on ClinicalTrials.gov Archive Site
  • 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 ]
Proportion of subjects able to undergo limb or joint sparing (eg, curettage) surgical procedures [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of Bone
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

To determine how safe denosumab is in treating subjects with giant cell tumor of bone
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • GCT
  • Giant Cell Tumor of Bone
  • Benign GCT
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
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.
Intervention: Drug: Denosumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
511
October 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00680992
20062004
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP