EUCTR2018-002096-17-IT进行中（未招募）1 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 (EORTC)0 个研究点目标入组 100 人开始时间: 2020年4月28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
- 100
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
- •* 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
- •* 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.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
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2 期
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