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

Tracking Information

First Received Date ^ICMJE

May 15, 2008

Last Updated Date

October 15, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00680992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of Bone

Official Title ^ICMJE

An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Cancer
GCT
Giant Cell Tumor of Bone

Intervention ^ICMJE

Drug: Denosumab

Study Arms / Comparison Groups

Experimental: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

October 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Amgen Call Center

866-572-6436

Location Countries ^ICMJE

United States, Australia, Austria, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00680992

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20062004

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

October 2009

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