EUCTR2009-015459-25-BE进行中（未招募）1 期
An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor) therapies
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
- 550
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. Written informed according to local guidelines must be obtained before any study assessments are performed.
- •2. Age = 18 years old.
- •3. Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
- •4. Patients receiving adjuvant VEGF targeted therapy or mTOR inhibitors may have this treatment count as part of one prior VEGF or one prior mTOR therapy if disease progression occurred on or within 6 months of stopping the adjuvant treatment
- •5. Prior treatment with cytokines and anti-cancer vaccines is permitted.
- •6. Patients must have had disease progression on or within 6 months of stopping the last therapy (VEGF-targeted agent and/or the mTOR inhibitor therapy).
- •7. Patients must have at least one measurable lesion at baseline (according to RECIST 1.1) using Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI). If skin lesions are selected as target lesions at baseline, follow procedure specified on Section 7.6.4.
- •8. Karnofsky performance status = 70%
- •9. Patients must have the following laboratory values:
- •Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hemoglobin (Hgb) > 9 g/dL
- •Serum total bilirubin: = 1.5 x ULN
- •ALT and AST = 3.0 x ULN (Patients with or without liver metastases)
- •Serum creatinine = 1.5 x ULN
- •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 250
排除标准
- •1. Patients who have previously received sorafenib therapy in neoadjuvant, adjuvant or metastatic setting
- •2. Patients who have previously received TKI258 or other VEGFR such as brivanib in the neoadjuvant, adjuvant or metastatic setting
- •3. Patients with brain metastases or any history of brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
- •4. Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
- •5. Patients who have received the last administration of an anticancer targeted small molecule therapy = 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from side effects of such therapy
- •6. Patients who have received the last administration of nitrosurea or mitomycin-C = 6 weeks prior to starting study treatment, or who have not recovered from side effects of such therapy
- •7. Patients who have received the last administration of an anticancer monoclonal antibody, immunotherapy, or chemotherapy (except nitrosureas and mitomycin-C) = 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
- •8. Patients who have received radiotherapy = 4 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions = 2 weeks prior to starting study treatment is allowed.
- •9. Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) = 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
- •10. Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months.
- •11. Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- •Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •- History or presence of serious uncontrolled ventricular arrhythmias
- •- Clinically significant resting bradycardia
- •- LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (which ever is higher)
- •- Any of the following within 6 months prior to starting study treatment: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)
- •- Uncontrolled hypertension defined by a SBP = 160 mm Hg and/or DBP = 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •Known diagnosis of human immunodeficiency virus (HIV) infection. HIV testing is not mandatory but ishould be performed if locally required.
- •Patients who are
研究者
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