EUCTR2011-000882-11-FR进行中（未招募）1 期
A comparison of blood and tissue biomarkers before and after nephrectomy in the firstline setting with everolimus in patients with locally advanced or metastatic renal cell carcinoma - NEORAD
A.R.T.I.C. (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie )0 个研究点目标入组 60 人开始时间: 2011年7月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Patients with advanced RCC or a resectable renal tumor and at least one measurable inoperable metastasis (³1 cm), in whom anti-angiogenic therapy is indicated
- •2. Patients without target lesions, with bone metastasis
- •3. Histologically confirmed clear cells RCC (biopsy) and possibility of adequate tumor sampling prior to treatment
- •4. No prior systemic treatment for RCC
- •5. Male or female, 18 years
- •6. Performance status ECOG 0-1
- •7. Life expectancy 3 months
- •8. Adequate organ function as defined by the following criteria:
- •- Total serum bilirubin £ 2 x ULN (Gilbert’s disease exempted)
- •- Serum transaminases and alkaline phosphatases £2.5 x ULN, or in case of liver or bone metastasis £ 5x ULN
- •- Serum creatinine £ 2 x ULN, creatinine clearance ³ 50 ml/min
- •- Absolute neutrophil count (ANC) ³ 1500/mm3
- •- Platelets ³ 100,000/mm3
- •- Hemoglobin ³ 10.0 g/dL
- •- INR £ 1.7 or prothrombin time (PT) £ 6 sec
- •- Fasting cholesterol < 5 mmol/L, triglycerides < 200 mg/dl, blood glucose < 1.5x
- •9. Negative pregnancy test within 7 days prior to enrollment
- •10. Signed and dated IRB/ICE-approved informed consent form
- •11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
- •tests and other study procedures.
- •12. Patient covered by the national health system
- •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 30
排除标准
- •1. Previous nephrectomy
- •2. Histology: Renal collecting duct carcinoma
- •3. Treatment in a clinical trial in the last 30 days
- •4. Previous treatment with everolimus or other mTOR-inhibitors and anti-angiogenic drugs
- •5. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack.
- •6. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment
- •7. Ongoing cardiac dysrhythmia of grade ³ 2, atrial fibrillation of any grade, QTc interval > 0.45
- •8. Treatment with anticonvulsant agents and vitamin K antagonists. Ongoing treatment with therapeutic doses of coumarin derivative anticoagulants (e.g. warfarin) or treatment within the 2 weeks before the first day of everolimus administration.
- •Prophylaxis with low dose warfarin for deep vein thrombosis is permitted (up to 2 mg/day). Low molecular weight heparin is allowed.
- •9. Any medical condition that might interfere with the absorption of oral medication.
- •10. Brain metastasis. (Note: Brain scan or MRI is mandatory).
- •11. Left ventricular ejection fraction (LVEF) value < 50% as assessed by echocardiography or multigated acquisition (MUGA) scan.
- •12. Pregnancy or breastfeeding. Women and men must agree to use effective contraception during the study period. Acceptable contraception includes implants, oral contraceptives, intrauterine devices, and surgical sterilization.
- •13. Any acute or chronic medical or psychiatric condition or laboratory abnormality that
- •would make the patient unsuited to study participation.
- •14. Any second malignancy within the last 5 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
- •15. Clinically significant gastrointestinal abnormalities including but not limited to:
- •a. Malabsorption syndrome
- •b. Major resection of the stomach or small bowel that could affect the absorption
- •of the study drug
- •c. Active peptic ulcer disease
- •d. Inflammatory bowel disease
- •e. Ulcerative colitis or other gastrointestinal conditions with increased risk of
- •perforation
- •f. History of abdominal fistula, gastrointestinal perforation, or intra abdominal
- •abscess within 28 days prior to beginning study treatment
- •g.Hépatite B/C
- •16. Hypersensitivity to everolimus or any excipient of everolimus.
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