Long-term Safety Follow-up of Subjects… | Clinical Trial

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

About this study

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. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Denosumab

Drug

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

Other names: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand

Primary outcomes

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

Time frame: Up to approximately 5 years

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.

Secondary outcomes

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

Time frame: Up to approximately 5 years

An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 [severe or medically significant but not immediately life-threatening], 4 [life-threatening], and 5 [death related to the AE]) using the Common Terminology Criteria for Adverse Events (CTCAE).
Number of Participants With Disease Progression or Recurrence of GCTB

Time frame: Up to approximately 5 years

Disease progression or recurrence is defined as the best post-baseline response of progressive disease (PD) without any post-baseline complete response (CR) /partial response (PR) /stable disease (SD) or a post-baseline response of PD following a post-baseline CR/PR/SD. PD is defined as the response of progressive disease, locally recurrent disease or distant recurrence. CR is defined as no evidence of disease following surgical resection while on study 20062004. PR is defined as no new lesion or disease progression while enrolled in study 20062004. SD is defined as local disease progression/recurrence or distant metastatic disease while on study 20062004.
Number of Participants Receiving GCTB Interventions

Time frame: Up to approximately 5 years

GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Oct 4, 2017
Registry last updated: May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed