EUCTR2011-002887-26-AT进行中（未招募）1 期
A randomized, double-blind, multicenter, Phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin - RADIANT-4
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
- 302
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
- •1.Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin.
- •2.No history of and no active symptoms related to carcinoid syndrome (or other hypersecretory syndromes).
- •3.Patients treated with prior SSA and/or Interferon (IFN) may be included. These patients must discontinue treatment prior to the day of randomization as follows:
- •4.Radiological documented disease progression within 6 months prior to randomization
- •5.Measurable disease
- •6.WHO performance status =1
- •7.Adequate bone marrow, lifer and renal function
- •Other protocol-defined inclusion/exclusion criteria may apply
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •1.Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, gastrinoma, goblet cell carcinoid, and small cell carcinoma.
- •2.Patients with pancreatic NET or NET of origins other than GI or lung
- •3.Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea).
- •4.Prior systemic cytotoxic chemotherapy or targeted therapy.
- •6.Hepatic intra-arterial embolization within the last 6 months (or 1 month if there is measurable disease in other organs besides the liver)
- •7.Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus).
- •8.Known intolerance or hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus).
- •9.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus.
- •10.Uncontrolled diabetes mellitus.
- •11.Patients who have any severe and/or uncontrolled medical conditions such as:
- •unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =6 months prior to randomization, serious uncontrolled cardiac arrhythmia;
- •active or uncontrolled severe infection;
- •liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA).
- •12.Chronic treatment with corticosteroids or other immunosuppressive agents.
- •13.Known history of HIV seropositivity.
- •14.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •Other protocol-defined exclusion criteria may apply.
研究者
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