NCT03620149终止2 期
Reduced Dose-density of Denosumab for Maintenance Therapy of Unresectable Giant Cell Tumor of Bone: a Multicenter Phase II Study "REDUCE"
European Organisation for Research and Treatment of Cancer - EORTC8 个研究点 分布在 4 个国家目标入组 2 人开始时间: 2019年9月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study is a multi-center, multi-national, open label, single arm phase 2 study of single-agent denosumab.
The objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-term use (> 1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC 12-weekly instead of 4-weekly) will be investigated, starting after 1-year (12-15 months) of denosumab full dose, as per current label. The impact on OsteoNecrosis of the Jaw (ONJ) without compromising disease control will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary or metastatic unresectable GCTB or resectable GCTB but not a candidate for surgery, excluding primary or metastatic GCTB in the jaw.
- •Evidence of active disease at time of registration based on local investigator's assessment (according to RECIST v1.1)
- •Age ≥ 18 years old and skeletally mature (ie, radiographic evidence of at least 1 mature long bone (e.g. humerus with closed growth epiphyseal plate)
- •Patient must have received denosumab before entering this trial:
- •The duration of treatment with full dose denosumab (120 mg SC ) as per current label must be at least 12 months and patient may have received up to 15 months of denosumab.
- •And patient must have received at least 12 doses of denosumab 120 mg before entering into this trial.
- •ECOG/WHO PS 0-2
- •Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
- •Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides, either from the primary tumor or a metastatic lesion, must be available for histological central review.
- •Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first reduced dose of study treatment.
- •WOCBP should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months after the last treatment cycle. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •Intrauterine device (IUD)
- •Intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •Vasectomized partner
- •Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
- •Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 5 months after the last study treatment.
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
- •Concurrent bisphosphonate treatment and calcitonin
- •Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
- •Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
- •Creatinine clearance < 30 mL/min
- •Hemoglobin < 10.0 g/dL or 6.2 mmol/L
- •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 dental/oral surgery
- •Planned invasive dental procedure for the course of the study
- •Known hypersensitivity to the active substance or to any of the excipients (glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20)
- •Treatment with other investigational device or drug 30 days prior to registration
- •Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
- •Unstable systemic disease including active and uncontrolled infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before registration
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究组 & 干预措施
Denosumab
Experimental
denosumab at reduced dose
干预措施: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 5.8 years after first patient in
according to RECIST 1.1
Osteonecrosis of the jaw (ONJ) incidence
时间窗: 5.8 years after first patient in
次要结局
- Occurrence of Adverse Events(5.8 years after first patient in)
- Overall survival(5.8 years after first patient in)
- Denosumab treatment duration(5.8 years after first patient in)
研究者
研究点 (8)
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进行中（未招募）
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Trial assessing modified denosumab treatment as option for patients with a giant cell tumor of the bone, which cannot be treated by surgery or where surgery is not the best optioMedDRA version: 20.0Level: LLTClassification code 10005968Term: Bone giant cell tumorSystem Organ Class: 100000004864Giant cell tumor of boneEUCTR2018-002096-17-GBEuropean Organisation for Research and Treatment of Cancer (EORTC)100