EUCTR2017-005017-31-IT进行中（未招募）1 期
DENOSUMAB IN EBV RELATED NASOPHARYNGEAL CARCINOMA (NPC) AS A MODEL FOR RANK-MEDIATED IMMUNOLOGIC MODULATION OF VIRUS-RELATED TUMOURS – DERN STUDY - DER
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 47 人开始时间: 2021年5月24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
- 47
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
- •1.EBV related nasopharyngeal cancer
- •2.Detectable and quantifiable plasmatic EBV DNA
- •3.Recurrent and/or metastatic disease not suitable for curative treatment
- •5.Suitable for polychemotherapy
- •6.Age = 18 years
- •7.Informed consent signed
- •8.Subject has adequate organ functions, evidenced by the following:
- •a.AST (SGOT), ALT (SGPT) = 2.5 x upper limit of normal range (ULN), or = 5 x ULN range if liver metastasis present
- •b.Total bilirubin = 1.5 x ULN
- •c.creatinine clearance 24/h > 50 mL/min
- •d.Total serum calcium > 8.8 mg/dL
- •e.Absolute neutrophil count = 1.5 x 10*9 cells/L
- •f.Platelets = 100 x 10*9 cells/L
- •g.Haemoglobin = 9 g/dL
- •9.If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 5 months post-dosing.
- •10.Subject understands and voluntarily signs an ICF prior to any study-related assessments/procedures are conducted.
- •11.Subject is able to adhere to the study visit schedule and other protocol requirements.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Having received 1 or more chemotherapy line for recurrent/metastatic disease
- •2.Any residual CTCAE grade = 2 toxicity
- •3.Subject has any other malignancy within 3 years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanoma skin cancer (all treatment of which should have been completed 6 months prior to enrolment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer T1a, Gleason < 7, PSA <10 ng/ml.
- •4.Subject has had radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting IP, and/or from whom = 30% of the bone marrow was irradiated.
- •5.Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry.
- •6.Chronic systemic immunosuppressive therapy that cannot be interrupted during treatment study.
- •7.Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
- •8.Subject has a known or suspected hypersensitivity to study drugs.
- •9.Subject is pregnant or breast feeding.
- •10.Subject is receiving prohibited medication as per section 7.4.2 and suspension of such treatment is considered unsafe.
- •11.Subject has history of prior or current osteonecrosis of the jaw (ONJ).
- •12.Subject has history of prior irradiation to the mandible, specified as:
- •Dose constraints to the mandible: Dmax = 70 Gy, V50 = 62 Gy and V60 = 20 Gy
- •Mandible should be contoured as whole organ, with alveolar bone, excluding teeth.
- •13.Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, contraindicate subject participation in the clinical study.
研究者
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