NL-OMON47949已完成2 期
Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study REDUCE - REDUCE
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 9 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Histologically proven primary or metastatic unresectab~e 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.
- •* ECOGNVHO PS 0-2
- •* Albumin-adjusted serum calcium level >_ 2.0 mmollL (8.0 mg/d L)
- •* 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 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
- •* Creatinine clearance &It 30 mL/min
- •* Hemoglobin &It 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
- •registrationKnown 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
研究者
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