Safety 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:	NCT00680992

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	Drug: Denosumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Bone Cancer Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

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:

Proportion of subjects able to undergo limb or joint sparing (eg, curettage) surgical procedures [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Denosumab: Experimental 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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key 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 GCT, or multiple lesions including pulmonary metastases) OR subjects whose planned initial surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity, other than curettage with complete resection of tumor
Karnofsky performance status ≥ 50% (ie, ECOG status 0, 1, or 2)
Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate])
- 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

Key exclusion criteria:

Currently receiving other GCT 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 GCT giant cell-rich tumors
Known or suspected current diagnosis of brown cell tumor of bone
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
Women or men unwilling to use adequate contraceptive measures
Women of child-bearing potential are evidently pregnant (eg, positive HCG test) or breast feeding
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
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

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

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, California
Research Site	Recruiting
Santa Monica, California, United States
United States, District of Columbia
Research Site	Recruiting
Washington, District of Columbia, United States
United States, Michigan
Research Site	Recruiting
Ann Arbor, Michigan, United States
United States, Minnesota
Research Site	Recruiting
Minneapolis, Minnesota, United States
United States, Pennsylvania
Research Site	Recruiting
Radnor, Pennsylvania, United States
Australia
Research Site	Recruiting
East Melbourne, Australia
Research Site	Recruiting
Perth, Australia
Austria
Research Site	Recruiting
Wien, Austria
France
Research Site	Recruiting
Lyon, France
Research Site	Recruiting
Villejuif, France
Germany
Research Site	Recruiting
Bad Saarow, Germany
Italy
Research Site	Recruiting
Bologna, Italy
Research Site	Recruiting
Milano, Italy
Netherlands
Research Site	Recruiting
Leiden, Netherlands
Spain
Research Site	Recruiting
Palma de Mallorca, Spain
Research Site	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

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

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20062004
Study First Received:	May 15, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00680992 History of Changes
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

Giant Cell Tumor of Bone
Bone Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Giant Cell Tumors
Neoplasms, Bone Tissue
Neoplasms by Histologic Type
Neoplasms by Site

Musculoskeletal Diseases
Bone Neoplasms
Neoplasms, Connective Tissue
Giant Cell Tumor of Bone
Bone Diseases

ClinicalTrials.gov processed this record on July 02, 2009