Overview

This trial is active, not recruiting.

Conditions cancer, gct, giant cell tumor of bone, benign gct
Treatment denosumab
Phase phase 2
Sponsor Amgen
Start date June 2008
End date November 2017
Trial size 530 participants
Trial identifier NCT00680992, 20062004

Summary

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

United States Minnesota
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.

Primary Outcomes

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

Secondary Outcomes

Measure
Time to disease progression for Cohort 1
time frame: Interval (in days) from the enrollment date to the date of disease progression
Proportion of subjects without any surgery at month 6 for Cohort 2
time frame: Six months
Evaluate denosumab pharmacokinetics in adolescent and adult subjects with GCTB (PK subset)
time frame: 25 weeks

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

Official title An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Description To determine how safe denosumab is in treating subjects with giant cell tumor of bone
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Amgen.
Location data was received from the National Cancer Institute and was last updated in April 2016.