EUCTR2016-005244-42-FR进行中（未招募）1 期
An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Rich Tumors of Bone - DENOEUROSARC-007
eiden University Medical Center0 个研究点目标入组 60 人开始时间: 2019年9月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The population will consist of patients with the following tumor types:
- •- Pathologically proven giant cell rich tumor
- •Other giant cell rich lesions (primary bone, non-malignant, pathology
- •and radiology to be reviewed during multidisciplinary meeting LUMC)
- •- Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
- •- Measurable evidence of active disease within 1 year before study
- •- Albumin-adjusted serum calcium level = 2.0 mmol/L (8.0 mg/dL)
- •- Aged 18 years and up and skeletally mature
- •- ECOG performance status 0, 1 or 2
- •- Written signed informed consent
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Known or suspected current diagnosis of classic GCTB
- •- Known or suspected current diagnosis of underlying malignancy
- •including but not limited to high-grade sarcoma, osteosarcoma,
- •fibrosarcoma, malignant giant cell sarcoma
- •- Known or suspected current diagnosis of brown cell tumor of
- •hyperparathyroidism, Paget's disease or cherubism
- •- Known or suspected current diagnosis of primary soft tissue tumor
- •with invasion of the bone
- •- Known diagnosis of other malignancy within the past 5 years (patients
- •with definitively treated basal cell carcinoma and cervical carcinoma in
- •situ are permitted)
- •- Previous treatment with denosumab (with the exception of patients
- •eligible for re-treatment with denosumab after completing this study)
- •- Prior history or current evidence of osteonecrosis/osteomyelitis of the
- •- Active dental or jaw condition which requires oral surgery, including
- •tooth extraction
- •- Non-healed dental/oral surgery
- •- Planned invasive dental procedure for the course of the study
- •- Known hypersensitivity to denosumab
- •- Known hypersensitivity to products to be administered during the
- •study (calcium and/or vitamin D)
- •- Currently receiving other specific treatment for giant cell rich tumors of
- •bone (e.g., radiation, chemotherapy or embolization)
- •- Concurrent bisphosphonate treatment
- •- Major surgery less than 4 weeks prior to start of treatment
- •- Treatment with other investigational device or drug 30 days prior to
- •study enrollment
- •- Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial
- •infarction within 6 months before study enrollment
- •- Patient is pregnant or breast feeding, or planning to become pregnant
- •within 5 months after the EOT visit
- •- Patient, or partner of patient, of child bearing potential is not willing to
- •use a highly effective method of contraception (Cf. appendix D - Child-bearing potential and effective contraception) during treatment and for 5 months after the EOT visit
- •- Patient has any kind of disorder that compromises the ability of the
- •patient to give written informed consent and/or to comply with study
研究者
相似试验
进行中（未招募）
1 期
Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of BoneEUCTR2008-001606-16-GBAmgen Inc532
进行中（未招募）
1 期
Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of BoneGiant cell tumor of bone (GCTB)MedDRA version: 20.0Level: LLTClassification code 10005968Term: Bone giant cell tumorSystem Organ Class: 100000019081EUCTR2008-001606-16-DEAmgen Inc530
进行中（未招募）
不适用
Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of BoneEUCTR2008-001606-16-Outside-EU/EEAAmgen Inc530
进行中（未招募）
1 期
Denosumab in patients with giant cell rich tumors of bone.Aneurysmal bone cysts, giant cell granuloma, other giant cell rich lesions (primary bone, non-malignant)MedDRA version: 20.1Level: LLTClassification code 10018252Term: Giant cell granuloma peripheralSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10004430Term: Benign osteoblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008686Term: ChondroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10008733Term: Chondromyxoid fibromaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10002362Term: Aneurysmal bone cystSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-005244-42-NLeiden University Medical Center60
进行中（未招募）
1 期
Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of BoneGiant cell tumor of bone (GCTB)MedDRA version: 20.0Level: LLTClassification code 10005968Term: Bone giant cell tumorSystem Organ Class: 100000004864EUCTR2008-001606-16-ATAmgen Inc530