EUCTR2010-023032-17-IT进行中（未招募）不适用
An open-label, multi-center, expanded access study of everolimus in patients with advanced neuroendocrine tumors.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Age = 18 years old; 2. Advanced (unresectable or metastatic) biopsy-proven neuroendocrine tumor of gastrointestinal, lung or pancreatic origin; 3. Performance Status 0-2 on the WHO scale; 4. Adequate bone marrow function as shown by: • ANC = 1.5 x 109/L, • Platelets = 100 x 109/L, • Hemoglobin >9 g/dL; 5. Adequate liver function as shown by: • Serum bilirubin = 1.5 x ULN, • ALT and AST = 2.5 x ULN. Patients with known liver metastases who have an AST and ALT = 5 x ULN, • INR < 1.3 (INR < 3 in patients treated with anticoagulants); 6. Adequate renal function as shown by: serum creatinine = 1.5 x ULN; 7. Fasting serum cholesterol = 300 mg/dL OR = 7.75 mmol/L AND fasting triglycerides = 2.5 x ULN; 8. Written informed consent obtained before any trial related activity and according to local guidelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible; 2. Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to enrollment; 3. Hepatic artery embolization within the last 2 months or cryoablation or radiofrequency ablation of hepatic metastasis within 2 months of enrollment; 4. Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus); 5. Patients with a known hypersensitivity to everolimus or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients; 6. Patients receiving chronic treatment with immunosuppressives; 7. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN; 8. 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 enrollment, serious uncontrolled cardiac arrhythmia, • active or uncontrolled severe infection, • Patients with a history of invasive fungal infections, • severe hepatic impairment (Child-Pugh class C), • severely impaired lung function; 9. Active bleeding diathesis; 10. Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required; 11. No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for = 3 years; 12. Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry. Note: Patients must have recovered from the acute effects of surgery prior to enrollment; 13. Female patients who are pregnant or nursing (lactating);14. Adults of reproductive potential who are not using effective birth control methods. Adequate contraceptives must be used throughout the trial and for 8 weeks after last study drug administration in female patients. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first administration of study drug; 15. Patients unwilling to or unable to comply with the protocol.
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