EUCTR2020-002541-41-AT招募中1 期
A phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3. - CABONE
niversitätsmedizin Göttingen0 个研究点目标入组 0 人开始时间: 2023年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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
- 性别
- All
入选标准
- •1.Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;
- •2.Tumor proliferation rate has to be > Ki67 20% and = Ki67 60% (local assessment);
- •3.Male, female, or diverse patients aged > 18 years without upper age limit;
- •4. Patients with up to four different antitumoral therapies
- •5.At least one measurable tumor lesions in CT or MRI scan;
- •6.Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
- •7.Patients must have a performance status of ECOG 0-2;
- •8.Patients must have a life expectancy of more than 3 months;
- •9.Hb> 9 mg/dl;
- •10.platelets >80T/µl;
- •11.white blood cells >3T/µL;
- •12.total bilirubin <3mg/dl;
- •13.AST and ALT <4xN;
- •14.Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2;
- •15.BUN <5xN;
- •16.lipase <3xN;
- •17.albumin =2.8 g/dL;
- •18.PT/PTT = 1.5 × ULN;
- •19.Urine protein:creatinine ration = 1 (Note: if proteinuria < 2g/l and increased proteinuria is ruled out by an urine teststick the protein:creatinine ratio does not need to be determined);
- •20.Written informed consent obtained according to international guidelines and local laws;
- •21.Ability to understand the nature of the trial and the trial related procedures and to comply with them
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1.Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
- •2.Patients with former treatment with TKI or VEGF receptor antagonist;
- •3.Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);
- •4.Patients with symptomatic brain metastases;
- •5.Patients with known HIV infection, acute and chronic-active hepatitis (type A, B or C) or another uncontrolled infection;
- •6.Patients with known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);
- •7.Patients with class III or IV congestive heart failure;
- •8.Patients with prolonged QTc (for women more than 470 ms, for men 450 ms);
- •9.Patients with uncontrolled hypertension (despite anti-hypertensive medication RR >160/110 mmHg);
- •10.Patients with severely impaired lung function;
- •11.Patients with history of organ transplant (exclusion: cornea transplantation);
- •12.Patients with clinical apparent acute or chronic gastric ulceration;
- •13.Patients with history of hemophilia;
- •14.Patients with surgery at the GI tract within the last 12 weeks;
- •15.Patients with patients with uncontrolled inflammatory bowel disease;
- •16.Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •17.Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- •18.Previous participation in this trial
- •19.concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone);
- •20.Known or persistent abuse of medication, drugs or alcohol;
- •21.Person who is in a relationship of dependence/employment with the sponsor or the investigator;
- •22.Current or planned pregnancy, nursing period
研究者
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