Safety and Efficacy Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of Bone - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00396279

Purpose

To determine how safe and effective denosumab is in treating subjects with giant cell tumor of bone.

Condition	Intervention	Phase
GCT Giant Cell Tumor of Bone	Drug: Denosumab	Phase II

MedlinePlus related topics: Bone Cancer Cancer

Drug Information available for: Denosumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects With Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone

Further study details as provided by Amgen:

Primary Outcome Measures:

Proportion of subjects with a response based on histopathology and/or imaging (radiography) [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile of denosumab (PK, antibody, AEs, disease markers during treatment; no PK or disease markers during follow-up) [ Time Frame: Duration of treatment and twenty-four months post-treatment ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	July 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Denosumab: Experimental	Drug: Denosumab 120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Subjects for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab
Radiation to affected region within 28 days before enrollment to study
Known diagnosis of osteosarcoma or brown tumor of bone
Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
Concurrent treatment with bisphosphonates, calcitonin, or interferon.

Other criteria also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396279

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040215
Study First Received:	November 2, 2006
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00396279
Health Authority:	Australia: Therapeutic Goods Administration; European Union: European Medicines Agency; United States: Food and Drug Administration

Keywords provided by Amgen:

Giant Cell Tumor of Bone

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Giant Cell Tumors
Musculoskeletal Diseases
Bone Neoplasms

Bone neoplasms
Giant Cell Tumor of Bone
Bone Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms, Bone Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 14, 2009