EUCTR2004-002420-18-DE进行中（未招募）1 期
A prospective, non-randomized, non-controlled, open label, multicenter phase II Study: PTK 787/ ZK222584 in patients with advanced neuroendocrine tumors. - not available
Prof. B. Wiedenmann, Klinik für Gastroenterologie, Charité, Campus Virchow0 个研究点目标入组 54 人开始时间: 2005年2月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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 and immunohistologically confirmed neuroendocrine carcinoma
- •- Neuroendocrine tumor of foregut, midgut, hindgut or CUP with demonstrated progress within the last 6 months
- •- KI 67 < 15%
- •- Presence of measurable tumor lesions as determined by RECIST criteria
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- High grade malignant neuroendocrine tumor (Ki 67 >15%)
- •- Chemotherapy 4 weeks prior to entry on this study
- •- Embolisation or chemoembolisation less than 3 month prior to entry on this study
- •- Major surgery within 2 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy
- •- Patients who have received investigational drugs within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- •- Patients who are pregnant or breast feeding
- •- Adults of reproductive potential not employing an effective method of birth control (such as barrier methods). Oral, implantable or injectable contraceptives are not considered effective for this study due to potential CYP450 interaction
- •- Current severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease or active uncontrolled infection) which could compromise participation in the study
- •- Acute or chronic active liver disease (e.g., hepatitis, cirrhosis)
- •- Presence of clinically symptomatic brain metastasis
- •- Confirmed HIV infection
- •- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea which leads to malabsorption, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
- •- Second malignant tumor (except non-melanoma skin tumors and carcinoma in situ of the cervix)
- •- Patients who are taking Coumadin (warfarin sodium) or other medication metabolized by cytochrome p450, heparin is acceptable
研究者
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