Investigating the potential clinical benefit of Selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy. - SEL-I-METRY

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 60 人2015年9月28日

概览

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干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Sheffield Teaching Hospitals NHS Foundation Trust
入组人数: 60
状态: 进行中（未招募）
最后更新: 10年前

概览研究者入排标准结局指标相似试验

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注册库

who.int

开始日期

2015年9月28日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Sheffield Teaching Hospitals NHS Foundation Trust

入排标准

入选标准

•Diagnosed with locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hürthle cell, or poorly differentiated carcinoma) with at least one measurable lesion as measured by computed tomography (CT) or magnetic resonance imaging (MRI)
•Participants must have iodine refractory disease, defined below:
•One or more measurable lesions that do not demonstrate iodine uptake on a previous radioiodine scan (diagnostic uptake or post therapy)
•One or more measurable lesions that have progressed by RECIST 1\.1 criteria within 12 months of I\-131 therapy, despite demonstrable radioiodine avidity at the time of that treatment
•Participants must have radiological progression by RECIST 1\.1 criteria within the prior 12 months
•Measurable disease by RECIST 1\.1 criteria.
•ECOG Performance Status \= 1 and able to tolerate radioiodine therapy
•Life expectancy of at least 12 weeks
•Required laboratory values within 14 days of day 1 of treatment:
•oAdequate thyroid\-stimulating hormone (TSH) suppression \< 0\.5 mU/L

排除标准

•Foci of anaplastic thyroid cancer identified on histology
•Able to receive curative surgery or radiation therapy
•Major surgery with the exception of surgical placement for vascular access, open biopsy, or significant traumatic injury \= 30 days prior to registration
•Previous or concurrent cancer distinct in primary site or histology from thyroid cancer within previous 5 years, except for cervical cancer in situ, treated basal cell carcinoma, squamous cell carcinoma of the skin or superficial bladder tumour
•Have received or are receiving an IMP or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment (6 weeks for nitrosoureas, mitomycin, and suramin), or within a period during which the IMP or anticancer treatment has not been cleared from the body (e.g. a period of 5 ‘half\-lives’), whichever is the most appropriate and as judged by the investigator
•Any unresolved toxicity \=CTCAE Grade 2 from previous anti\-cancer therapy, except for alopecia
•Prior exposure to Tyrosine Kinase, MEK, RAS or RAF inhibitors
•Known or suspected allergy to Selumentinib or hypersensitivity to Selumetinib or any excipient agents or history of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib
•Known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti\-convulsant medications for at least 4 weeks prior to the first dose of study medication
•Requiring medication with high iodine content (e.g. amiodarone)