An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone

Phase 1

• Conditions: Giant Cell Tumor (GCT) of Bone; MedDRA version: 9.1Level: LLTClassification code 10005968Term: Bone giant cell tumor

• Registration Number: EUCTR2008-001606-16-FR
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-25
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment
- Measurable evidence of active disease within 1 year before study enrollment
- Subjects with surgically unsalvageable disease (eg, sacral, spinal GCT, or multiple lesions including pulmonary metastases) OR subjects whose planned initial surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity, other than curettage with complete resection of tumor
- Karnofsky performance status = 50% (ie, ECOG status 0, 1, or 2)
- Adults
- Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Currently receiving other GCT specific treatment (eg, radiation, chemotherapy, or embolization)
- Concurrent bisphosphonate treatment
- Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
- Known or suspected current diagnosis of non GCT giant cell-rich tumors
- Known or suspected current diagnosis of brown cell tumor of bone
- Known diagnosis of second malignancy within the past 5 years
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- Active dental or jaw condition which requires oral surgery
- Non-healed dental/oral surgery
- Planned invasive dental procedure for the course of the study
- Women or men unwilling to use adequate contraceptive measures
- Thirty days or less since receiving an investigational product
- Subject has known sensitivity to any of the products to be administered during dosing
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety profile of denosumab in subjects with GCT of bone;Secondary Objective: - Evaluation of time to disease progression in subjects with unsalvageable GCT treated with denosumab<br> - Evaluation of the proportion of subjects able to undergo limb or joint sparing (eg, curettage) surgical procedures in denosumab treated subjects with salvageable GCT who would have otherwise required en bloc excision;Primary end point(s): The primary endpoint is the safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort of the study.