Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Sponsor

Amgen (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03301857

Collaborator

(none)

Enrollment

Locations

Arms

68.3

Anticipated Duration (Months)

6.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Tumor of Bone	Drug: Denosumab (Cohort A)	Phase 4

Detailed Description

Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Actual Study Start Date :

Nov 13, 2017

Anticipated Primary Completion Date :

Jul 25, 2023

Anticipated Study Completion Date :

Jul 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Denosumab Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.	Drug: Denosumab (Cohort A) Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). Other Names: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand
No Intervention: Safety Follow up Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).

Arm

Intervention/Treatment

Experimental: Denosumab

Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.

Drug: Denosumab (Cohort A)

Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).

Other Names:

AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand

No Intervention: Safety Follow up

Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).

Outcome Measures

Primary Outcome Measures

Rate of adverse events of interest in subjects with GCTB treated with denosumab [Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.]
Evaluate adverse events of interest in subjects with GCTB treated with denosumab.

Secondary Outcome Measures

Rate of treatment-emergent adverse events for subjects who are receiving denosumab. [Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.]
Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.
Rate of serious adverse events for all subjects. [Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.]
Evaluate serious adverse events for all subjects.
Rate of disease progression or recurrence of GCTB for all subjects. [Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.]
Summarize the rate of disease progression or recurrence of GCTB for all subjects.
Rate of GCTB interventions for all subjects. [Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.]
Summarize the use of GCTB interventions for all subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject was previously enrolled in Study 20062004.
Subject or subject's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarcoma Oncology Research Center LLC	Santa Monica	California	United States	90403
2	Washington Cancer Institute at MedStar Washington Hospital	Washington	District of Columbia	United States	20010
3	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota	United States	55455
4	Mount Sinai Beth Israel Downtown	New York	New York	United States	10003
5	Abramson Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19106
6	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
7	Centre Leon Berard	Lyon CEDEX 08		France	69373
8	Institut Gustave Roussy	Villejuif		France	94805
9	Istituti Ortopedici Rizzoli	Bologna		Italy	40136
10	Instytut Matki i Dziecka	Warszawa		Poland	01-211
11	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy	Warszawa		Poland	02-781
12	Hospital Universitari Son Espases	Palma de Mallorca	Baleares	Spain	07010
13	Skane Universitetssjukhus	Lund		Sweden	221 85
14	Royal Orthopaedic Hospital	Birmingham		United Kingdom	B31 2AP