EUCTR2016-004011-12-ES进行中（未招募）1 期
Phase II study to evaluate efficacy and safety of sunitinib therapy in patients with metastatic renal clear cell carcinoma who have progressed to first-line immunotherapy treatment (INMUNOSUN Study) - INMUNOS
SOGUG (Spanish Oncology Genitourinary Group)0 个研究点开始时间: 2017年1月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Eighteen years or older on the day of consent
- •2. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
- •3. Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, antiPDL1 o antiCTLA4) for the first line
- •4. Measurable disease per RECIST 1.1 as determined by the investigator
- •5. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
- •6. Recovery of toxicities related to any prior treatments to = Grade 1 CTCAE v.4.03, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
- •7. ECOG Performance Status (PS) 0-2
- •8. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP <150/90 mmHg before the start of study treatment.
- •9. Adequate marrow function
- •- Absolute neutrophil count (ANC) = 1500/mm3 (= 1.5 GI/L).
- •- Platelets = 100,000/mm3 (= 100 GI/L).
- •- Hemoglobin = 9 g/dL (= 5,6 mmol/L).
- •10. Adequate liver function
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
- •- Total bilirubin = 1.5 × ULN.
- •11. Adequate kidney function: calculated creatinine clearance = 30 mL/min (= 0.5 mL/sec) using the Cockroft-Gault equation
- •12. Proteinuria <2+ on urine test strip
- •13. Prothrombin Time (PT) or International Standard Ratio (INR) = 1.2 x ULN.
- •14. Life expectancy >3 months.
- •15. Patient able to ingest study drug and meet study follow-up requirements.
- •16. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
- •17. Female subjects of childbearing potential must not be pregnant at screening.
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
- •2. Major surgery within 3 weeks of patient inclusion
- •3. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
- •4. Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken prior to (3 months) patient inclusion
- •5. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •6. Current treatment on another clinical trial.
- •7. Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
- •8. Prior radiation therapy to >25% of the bone marrow.
- •9. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- •10. Any gastrointestinal malabsorption disorder or any other condition that, in the opinion of the investigator, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
- •11. Presence of an unhealed wound or active ulcer.
- •12. Diarrhea grade III/IV in the screening period.
- •13. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •14. Clinically significant cardio-cerebrovascular disease within 6 months prior to initiation of treatment.
- •15. Ongoing cardiac dysrhythmias of NCI CTCAE grade =2, atrial fibrillation of any grade that require treatment.
- •16. QTc interval >500 msec.
- •17. Active hemoptysis within 6 weeks prior to initiation of study treatment.
- •18. Evidence of active bleeding or hemorrhagic diathesis.
- •19. Presence of endobronchial lesions and / or lesions that infiltrate large vessels.
- •20. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •21. Other clinically significant alterations:
- •- Known human immunodeficiency virus (HIV) infection.
- •- Presence of an uncontrolled active infection.
- •- Presence of uncontrolled or symptomatic hypothyroidism.
- •- Moderate-severe liver disease (Child Pugh B-C).
- •- Requirement for hemodialysis or peritoneal dialysis.
- •- History of solid organ transplantation.
- •22. Pregnancy or breastfeeding.
- •23. Any disease that, in the opinion of the investigator, interferes with the patient's ability to participate in the clinical trial.
研究者
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