NCT04524208进行中（未招募）2 期
CABONEN - A Phase II Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3
Karsten Gavenis15 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 15
- 主要终点
- Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months.
研究概览
简要总结
The main objective of this clinical trial represents the evaluation of efficacy of the tyrosine kinase inhibitor Cabozantinib in patients with NEN G3 with a proliferation rate of Ki67 20 - 60%.
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
- •Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;
- •Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment);
- •Male, female, or diverse patients aged > 18 years without upper age limit;
- •At least one measurable tumor lesions in CT or MRI scan;
- •Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
- •Patients must have a performance status of ECOG 0-2;
- •Patients must have a life expectancy of more than 3 months;
- •Hb> 9 mg/dl;
- •platelets >80T/µl;
- •white blood cells >3T/μL;
- •total bilirubin <3mg/dl;
- •AST and ALT <4xN;
- •Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2;
- •lipase <3xN;
- •albumin ≥2.8 g/dL;
- •PT/PTT ≤ 1.5 × ULN;
- •urine protein: creatinine ratio ≤ 1;
- •Written informed consent obtained according to international guidelines and local laws;
- •Ability to understand the nature of the trial and the trial related procedures and to comply with them;
排除标准
- •Patients younger than 18 years;
- •Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
- •Patients with former treatment with TKI or VEGF receptor antagonist;
- •Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);
- •Patients with symptomatic brain metastases;
- •Patients with Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection;
- •Patients with Known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);
- •Patients with class III or IV congestive heart failure;
- •Patients with QTc more than 500 ms or 140% of normal range according to age;
- •Patients with uncontrolled hypertension;
- •Patients with severely impaired lung function;
- •Patients with history of organ transplant (exclusion: cornea transplantation);
- •Patients with clinical apparent acute or chronic gastric ulceration;
- •Patients with history of hemophilia;
- •Patients with surgery at the GI tract within the last 12 weeks;
- •Patients with patients with uncontrolled inflammatory bowel disease;
- •Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- •Previous participation in this trial
- •concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone);
- •Known or persistent abuse of medication, drugs or alcohol;
- •Person who is in a relationship of dependence/employment with the sponsor or the investigator;
- •Patients who cannot give informed consent;
- •Current or planned pregnancy, nursing period;
研究组 & 干预措施
Treatment-Arm
Experimental
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months.
时间窗: 6 months
Disease control rate (DCR) 6 months after treatment start .
次要结局
- Evaluate exposure time.(12 months)
- Evaluate short- and long term efficacy of Cabozantinib treatment via DCR.(12 months)
- Evaluate short- and long term efficacy of Cabozantinib treatment via ORR.(12 months)
- Assess quality-of-life during and after Cabozantinib treatment.(15 months)
- Evaluate short- and long term efficacy of Cabozantinib treatment via PFS.(24 months)
- Evaluate short- and long term efficacy of Cabozantinib treatment via OS.(24 months)
研究者
Karsten Gavenis
Project Manager
University Medical Center Goettingen
研究点 (15)
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