An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone - Denosumab 20062004

Phase 1

• Conditions: Treatment of Giant Cell Tumor (GCT) of Bone; MedDRA version: 9.1Level: LLTClassification code 10005970Term: Bone giant cell tumour benign

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-27
• Study Completion: 2018-05-17
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 532

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, pr 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 study procedures

Study & Design

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