Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Phase 2

Completed

• Conditions: Benign Giant Cell Tumors; Cancer; Giant Cell Tumors; Giant Cell Tumor of Bone
• Interventions: Drug: Denosumab

• Registration Number: NCT00680992
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

To determine how safe denosumab is in treating subjects with GCTB

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-20
• Study Start: 2008-09-09
• Primary Completion: 2018-05-17
• Study Completion: 2018-05-17
• Results First Submitted: 2018-11-12
• Results First Submitted QC: 2018-11-12
• Results First Posted: 2018-12-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Denosumab	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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).	AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity...
Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters	Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).	Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of parti...

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability	From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).	Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease St...
Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2	At month 6.	The percentage of participants without any surgery at month 6 was equivalent to the number of participants without any surgery by month 6 divided by the number of cohort 2 participants who had an opportunity to complete 6 months of treatment, expressed as a percentage.
Mean Serum Denosumab Trough Concentrations	Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.	Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Birmingham, United Kingdom