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Giant Cell Tumor of BonePhase 4NCT04586660

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

A Phase 4 study testing XGEVA® in people with Giant Cell Tumor of Bone, run by Amgen at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 12 years and older
Conditions the study is for
Giant Cell Tumor of Bone
What is being tested?
XGEVA®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
10 sitesin 2 countries
Study dates
17 Aug 2023to 7 Mar 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

China8 sites

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The Third Affiliated Hospital Of Southern Medical University

    Guangzhou, Guangdong, 510630

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510663

  • The Second Affiliated hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Harbin Meidical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Tangdu Hospital of Air Force Medical University

    Xi'an, Shaanxi, 710032

Other trials in China

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: An Open-label, Multi-center, Phase 4 Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

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

Being tested
XGEVA®
Keywords
Giant cell tumor of bone (GCTB), XGEVA®
Medical subject headings
Giant Cell Tumor of Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XGEVA®Drug

    Also called Denosumab

    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.

Study groups in NCT04586660
Study groupRoleWhat they receive
Surgically unsalvageable diseaseExperimentalParticipants with surgically unsalvageable disease (eg, sacral, spinal Giant cell tumor of bone [GCTB], or multiple lesions including pulmonary metastases).
Receives: Drug: XGEVA®
Surgically salvageable diseaseExperimentalParticipants with surgically salvageable disease whose planned on-study surgery is associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy).
Receives: Drug: XGEVA®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response

    Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: Up to 36 months

Secondary outcomes (10)

  1. Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only)

    Measured: From baseline until end of treatment, up to a maximum of 36 months

  2. Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only)

    Measured: Month 36

  3. Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only)

    Measured: From time of surgery until end of treatment, up to a maximum of 36 months

  4. Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)

    Measured: Up to 36 months

  5. Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)

    Measured: Up to 36 months

  6. Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio)

    Measured: Baseline to Month 36

  7. Change from baseline in severity of pain assessed by Brief Pain Inventory - Short Form (BPI-SF) score

    Pain severity will be assessed using Brief Pain Inventory - Short Form. The minimum score is 0 (no pain) and the maximum score is 10 (worst pain imaginable). The higher the score means a worse outcome of more pain.

    Measured: Baseline to Month 36

  8. Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

    Measured: Baseline to end of safety follow-up, up to approximately 37 months

  9. Number of participants who experience adverse events of special interest

    Adverse events of special interest include hypocalcemia, hypercalcemia following investigational product discontinuation, atypical femoral fracture, and osteonecrosis of the jaw.

    Measured: Baseline to end of safety follow-up, up to approximately 37 months

  10. Serum XGEVA concentration levels

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start17 Aug 2023
  3. Primary completion7 Mar 2028 (estimated)
  4. Study completion7 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586660
Sponsor's protocol ID
20180119
Status last verified
Sep 2025
First submitted
7 Oct 2020
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing XGEVA® in people with Giant Cell Tumor of Bone, run by Amgen at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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