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

NCT03301857 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 201401142017-001758-32
• Study Type: interventional
• Target: 85
• Locations: 8 countries
• Sites: 14

Brief Summary

Study 20140114 will continue to follow participants 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.

Conditions

Giant Cell Tumor of Bone

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)

  EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.

  Up to approximately 5 years

Secondary Outcomes (3)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

  Up to approximately 5 years

• Number of Participants With Disease Progression or Recurrence of GCTB

  Up to approximately 5 years

• Number of Participants Receiving GCTB Interventions

  Up to approximately 5 years

Study Arms (2)

Denosumab

EXPERIMENTAL

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

Drug: Denosumab

Safety Follow-up

NO INTERVENTION

Participants 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.

Interventions

Denosumab DRUG

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

Also known as: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand

Denosumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participant 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 participant 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (14)

Sarcoma Oncology Research Center LLC

Santa Monica, California, 90403, United States

Location

Washington Cancer Institute at MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mount Sinai Beth Israel Downtown

New York, New York, 10003, United States

Location

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Istituti Ortopedici Rizzoli

Bologna, 40136, Italy

Location

Instytut Matki i Dziecka

Warsaw, 01-211, Poland

Location

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Skane Universitetssjukhus

Lund, 221 85, Sweden

Location

Royal Orthopaedic Hospital

Birmingham, B31 2AP, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: November 13, 2017
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

US (5); AU (1); GB (1); SE (1); ES (1); PL (2); FR (2); IT (1)