EUCTR2008-000077-38-ES进行中（未招募）不适用
Estudio de fase II, aleatorizado, abierto y multicéntrico, que compara el tratamiento con bevacizumab más RAD001 frente a interferón alfa-2a más bevacizumab en el tratamiento de primera línea de pacientes con carcinoma renal metastásico de células clarasA randomized, open label, multi-center phase II study to compare bevacizumab plus RAD001 versus interferon alfa-2a and bevacizumab for the first-line treatment of patients with metastatic clear cell carcinoma of the kidney
ovartis Farmacéutica S.A0 个研究点目标入组 360 人开始时间: 2008年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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. Patients with metastatic renal cell carcinoma and with histological or cytological confirmation of clear cell RCC (pathology report based on the tissue from the original diagnosis of renal cell cancer is acceptable). Any percentage of clear cell histology is acceptable.
- •3. Patients with at least one measurable lesion at baseline as per the RECIST criteria. If skin lesions are reported as target lesions, they must be documented (at baseline and at every physical exam) using color photography and a measuring device (such as a caliper) in clear focus to allow the size of the lesion(s) to be determined from the photograph.
- •4. Patients who had a prior partial or complete nephrectomy. Partial nephrectomy is allowed only if the resection margins were clearly negative.
- •5. Patients with a Karnofsky Performance Status ?70%.
- •6. Adequate bone marrow function as shown by: ANC ? 1.5 x 109/L, Platelets ? 100 x 109/L, Hb >9 g/dL.
- •7. Adequate liver function: serum bilirubin: ? 1.5 x ULN, ALT and AST ? 2.5x ULN. Patients with known liver metastases: AST and ALT ? 5x ULN.
- •8. Adequate renal function: serum creatinine ? 2.0 x ULN.
- •9. INR and PTT < 1.5. (Anticoagulation is allowed if target INR ? 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of randomization.)
- •10. Adequate lipid profile: total cholesterol < 300 mg/dL and triglyceride < 200 mg/dL.
- •11. Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the study treatment start.
- •12. Patients who give a written informed consent obtained according to local guidelines.
- •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
- •1. Age ? 18 years old
- •2. Patients with metastatic renal cell carcinoma and with histological or cytological confirmation of clear cell RCC (pathology report based on the tissue from the original diagnosis of renal cell cancer is acceptable). Any percentage of clear cell histology is acceptable.
- •3. Patients with at least one measurable lesion at baseline as per the RECIST criteria. If skin lesions are reported as target lesions, they must be documented (at baseline and at every physical exam) using color photography and a measuring device (such as a caliper) in clear focus to allow the size of the lesion(s) to be determined from the photograph.
- •4. Patients who had a prior partial or complete nephrectomy. Partial nephrectomy is allowed only if the resection margins were clearly negative.
- •5. Patients with a Karnofsky Performance Status ?70%.
- •6. Adequate bone marrow function as shown by: ANC ? 1.5 x 109/L, Platelets ? 100 x 109/L, Hb >9 g/dL.
- •7. Adequate liver function: serum bilirubin: ? 1.5 x ULN, ALT and AST ? 2.5x ULN. Patients with known liver metastases: AST and ALT ? 5x ULN.
- •8. Adequate renal function: serum creatinine ? 2.0 x ULN.
- •9. INR and PTT < 1.5. (Anticoagulation is allowed if target INR ? 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of randomization.)
- •10. Adequate lipid profile: total cholesterol < 300 mg/dL and triglyceride < 200 mg/dL.
- •11. Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the study treatment start.
- •12. Patients who give a written informed consent obtained according to local guidelines.
- •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
- •1. 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.
- •2. Patients who had radiation therapy within 28 days prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start).
- •3. Patients in anticipation of the need for major surgical procedure during the course of the study.
- •4. Patients with a serious non-healing wound, ulcer, or bone fracture.
- •5. Patients with a history of seizure(s) not controlled with standard medical therapy.
- •6. Patients who have received prior systemic treatment for their metastatic RCC. Adjuvant immunotherapy (vaccines acceptable, but no cytokines) completed 3 months prior to study treatment start is acceptable.
- •7. Patients who received prior therapy with VEGF pathway inhibitor (even in the adjuvant setting), such as sunitinib, sorafenib, and bevacizumab.
- •8. Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- •9. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.
- •10. Patients with evidence of current central nervous system (CNS) metastases or spinal cord compression.
- •11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
- •12. Patients with proteinuria at screening as demonstrated by either:
- •? Urine protein: creatinine (UPC) ratio ? 1.0 at screening.
- •? Urine dipstick for proteinuria ? 2+ (patients discovered to have ?2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ? 1g of protein in 24 hours to be eligible).
- •13. Patients with inadequately controlled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or > 100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy.
- •14. Patients receiving ongoing or with recent (within 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (>75 mg/day).
- •15. Patients receiving chronic systemic treatment with corticosteroids (dose of ? 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
- •16. Patients with a known history of HIV seropositivity.
- •17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
- •18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism (>1 episode of DVT/PE during the past year).
- •19. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- •? unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ? 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents ? 6 months before study treatment start
- •? severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air;
- •1. 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.
- •2. Patients who had radiation therapy within 28 days prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start).
- •3. Patients in anticipation of the need for major surgical procedure during the course of the study.
- •4. Patients with a serious non-healing wound, ulcer, or bone fracture.
- •5. Patients with a history of seizure(s) not controlled with standard medical therapy.
- •6. Patients who have received prior systemic treatment for their metastatic RCC. Adjuvant immunotherapy (vaccines acceptable, but no cytokines) completed 3 months prior to study treatment start is acceptable.
- •7. Patients who received prior therapy with VEGF pathway inhibitor (even in the adjuvant setting), such as sunitinib, sorafenib, and bevacizumab.
- •8. Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- •9. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.
- •10. Patients with evidence of current central nervous system (CNS) metastases or spinal cord compression.
- •11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
- •12. Patients with proteinuria at screening as demonstrated by either:
- •? Urine protein: creatinine (UPC) ratio ? 1.0 at screening.
- •? Urine dipstick for proteinuria ? 2+ (patients discovered to have ?2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ? 1g of protein in 24 hours to be eligible).
- •13. Patients with inadequately controlled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or > 100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy.
- •14. Patients receiving ongoing or with recent (within 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (>75 mg/day).
- •15. Patients receiving chronic systemic treatment with corticosteroids (dose of ? 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
- •16. Patients with a known history of HIV seropositivity.
- •17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
- •18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism (>1 episode of DVT/PE during the past year).
- •19. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- •? unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ? 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents ? 6 months before study treatment start
- •? severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
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