2024-510863-50-00招募中2 期
CABONEN – a phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3
Universitaetsmedizin Goettingen12 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2024年8月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Disease control rate (DCR) 6 months after treatment start (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))
研究概览
简要总结
Evaluate the efficacy of Cabozantinib treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed diagnosis of neuroendocrine neoplasia
- •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 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)
- •Tumor proliferation rate has to be > Ki67 20% and ≤ Ki67 60% (local assessment)
- •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
- •Male, female, or diverse patients aged ≥ 18 years without upper age limit
- •Patients with upto four different antitumoral therapies
- •At least one measurable tumor lesion 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
排除标准
- •Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN)
- •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 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)
- •Patients with former treatment with TKI or VEGF receptor antagonist
- •Known or persistent abuse of medication, drugs or alcohol
- •Person who is in a relationship of dependence/employment with the sponsor or the investigator
- •Current or planned pregnancy, nursing period
- •Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer)
- •Patients with symptomatic brain metastases
- •Patients with known HIV infection, acute and chronic-active 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 prolonged QTc (for woman more than 470 ms, for men 450 ms)
- •Patients with uncontrolled hypertension (despite anti-hypertensive medication RR:>160/110 mmHg)
结局指标
主要结局
Disease control rate (DCR) 6 months after treatment start (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))
Disease control rate (DCR) 6 months after treatment start (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))
次要结局
- Disease control rate 3 and 12 months after treatment start
- Objective response rate (ORR) 3 months after treatment start and best objective response rate
- Progression free survival (PFS) and overall survival (OS)
- Time on drug (TOD)
- EORTC QLQ-C30 Quality of Life Questionnaire monthly for 12 months after treatment start and after 15 months
- Serious adverse events and adverse events, Data Safety Monitoring Board (DSMB)
研究者
Nicole Kirchhof
Scientific
Universitaetsmedizin Goettingen
研究点 (12)
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