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

Giant Cell Tumor of Bone Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586660
• Other study ID #: 20180119
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2023
• Est. completion date: October 16, 2027

Study information

• Verified date: February 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: October 16, 2027
• Est. primary completion date: October 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking University Peoples Hospital	Beijing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Third Affiliated Hospital Of Southern Medical University	Guangzhou	Guangdong
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Meidical University Cancer Hospital	Harbin	Heilongjiang
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 36 months
Secondary	Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only)		From baseline until end of treatment, up to a maximum of 36 months
Secondary	Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only)		Month 36
Secondary	Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only)		From time of surgery until end of treatment, up to a maximum of 36 months
Secondary	Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)		Up to 36 months
Secondary	Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)		Up to 36 months
Secondary	Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio)		Baseline to Month 36
Secondary	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.	Baseline to Month 36
Secondary	Number of participants who experience one or more treatment-emergent adverse events (TEAEs)		Baseline to end of safety follow-up, up to approximately 37 months
Secondary	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.	Baseline to end of safety follow-up, up to approximately 37 months
Secondary	Serum XGEVA concentration levels		Up to 36 months

External Links

•   AmgenTrials clinical trials website