Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2028-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors

NCT04550949

Bone Metastases

UNKNOWN PHASE3

A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone

NCT05402865

Giant Cell Tumor of Bone

COMPLETED

Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China

NCT03358212

Giant Cell Tumor of Bone

UNKNOWN

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

NCT04494373

Bone Metastasis From Solid Tumors

UNKNOWN PHASE1

A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT

NCT04488822

Tenosynovial Giant Cell Tumor

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Tumor of Bone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgically unsalvageable disease

Participants with surgically unsalvageable disease (eg, sacral, spinal Giant cell tumor of bone \[GCTB\], or multiple lesions including pulmonary metastases).

Group Type EXPERIMENTAL

XGEVA®

Intervention Type DRUG

Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.

Surgically salvageable disease

Participants with surgically salvageable disease whose planned on-study surgery is associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy).

Group Type EXPERIMENTAL

XGEVA®

Intervention Type DRUG

Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

XGEVA®

Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Denosumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Chinese male or female adults aged ≥ 18 years or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) ≥ 12 years of age.
* Skeletally mature adolescents must weigh at least 45 kg.
* Pathologically confirmed giant cell tumor of bone (GCTB) within 1 year before study enrollment (central pathology review).
* Measurable evidence of active disease within 1 year before study enrollment.
* Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR participants whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity.
* Eastern Cooperative Oncology Group performance status (\[ECOG PS\] of ≤ 2).

Exclusion Criteria

* Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma.
* Known diagnosis of malignancy derived from non-musculoskeletal system within the past 5 years (participants with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted).
* Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease.
* Known or suspected current diagnosis of non GCTB giant cell-rich tumors.
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
* Active dental or jaw condition which requires oral surgery, including tooth extraction.
* Non-healed wound after dental/oral surgery.
* Planned invasive dental procedure for the course of the study.
* Any planned treatment with intravenous (IV) or oral bisphosphonates during the study.
* Currently receiving other GCTB-specific treatment (eg, radiation, chemotherapy, or embolization).
* Current or previous XGEVA treatment
* Concurrent bisphosphonate treatment
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of XGEVA.
* Female participants of childbearing potential unwilling to use 2 highly effective method of contraception or acceptable method of effective contraception during treatment and for an additional 5 months after the last dose of XGEVA.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test and/or urine pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of XGEVA.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of XGEVA.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of XGEVA.
* Participant has known sensitivity to any of the products to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
* Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
* Participant has any kind of disorder that compromises the ability of the participant to give written informed consent and/or to comply with study procedures.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No