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

Sponsor:	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 Benign GCT	Drug: Denosumab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

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:

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 ]

Estimated Enrollment:	375
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	September 2014 (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

Eligibility

Ages Eligible for Study:	12 Years and older
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

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

Contacts

Contact: Amgen Call Center

866-572-6436

Show 30 Study Locations

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:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00680992 History of Changes
Other Study ID Numbers:	20062004
Study First Received:	May 15, 2008
Last Updated:	January 10, 2012
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 February 13, 2012