EUCTR2017-001207-68-DE进行中（未招募）1 期
A multicenter single-arm pilot study of ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors - RamuNet
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •- Histologically confirmed unresectable metastatic G1-G3 differentiated pancreatic neuroendocrine tumor (non-functional and functional NET) with a proliferation rate assessed by Ki-67 up to 55% - excluding neuroendocrine carcinomas
- •- Age: 18-80 years
- •- Measurable disease (RECIST 1.1)
- •- Progressive disease under treatment with either non-DTIC-based chemotherapy, SSA analogues, everolimus or sunitinib.
- •- No prior therapy with DTIC is allowed. Prior therapy with temozolomide is allowed with a temozolomide-free interval of at least 6 months prior to trial inclusion. Prior TACE and SIRT allowed with a minimum of 3 months before study entry, prior PRRT with a minimum of 12 months before study entry
- •- ECOG 0-1
- •- Life expectancy > 12 weeks
- •- Adequate renal, hepatic, bone marrow and coagulation function
- •- Sexually active patiens: postmenopausal, surgically sterile, or use of effective contraception (Pearl Index <1). Female patients of childbearing potential: negative serum pregnancy test within 7 days prior to first dose of protocol therapy.
- •- Written informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Pregnancy or lactation.
- •- Secondary malignancy in patient’s history with the exception of: disease-free period > 5 years before randomization or non-melanoma skin cancer or curatively treated cervical carcinoma in situ or other noninvasive in situ neoplasm.
- •- Allergy against dacarbazine or ramucirumab
- •- Current enrolment or participation within the last 4 weeks in a clinical drug trial
- •- Any arterial thromboembolic events within 6 months prior to first dose of protocol therapy.
- •Insufficient liver function
- •- Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management
- •- Chronic antiplatelet therapy, once-daily aspirin use (maximum dose 325 mg/day) permitted
- •- Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy.
- •- History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant”) during the 3 months prior to first dose of protocol therapy
- •- Uncontrolled severe physical or mental disorders
- •- Pathological condition present that carries a high risk of bleeding
- •- History of gastrointestinal perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation.
- •- Major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy. Elective or planned major surgery to be performed during the course of the clinical trial.
- •- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.
- •- officially and/or legally accomodated persons
研究者
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