EUCTR2014-000777-38-IT进行中（未招募）1 期
Activity and safety of second line SOrafenib After Pazopanib in patients with metastatic renal cell carcinoma (SOAP Study) - SOAP
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
- 44
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
- •Age = 18 years
- •Patients with hystological diagnosis of Renal Cell Carcinoma (RCC)
- •Measurable disease
- •ECOG Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •- Hemoglobin ? 10.0 g/dl
- •- Absolute neutrophil count (ANC) >1,500/mm3
- •- Platelet count ? 100,000/ml
- •- Total bilirubin = 1.5 times the upper limit of normal
- •- ALT and AST = 2.5 x upper limit of normal
- •- Alkaline phosphatase = 4 x ULN
- •- PT-INR/PTT = 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
- •Prognosis according to Heng: good or intermediate
- •Previous treatment with pazopanib
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- •Signed informed consent must be obtained prior to any study specific procedures
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •First line treatment for metastatic RCC other than pazopanib.
- •History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).
- •History of HIV infection
- •Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •Brain or meningeal metastases
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •History of organ allograft
- •Patients with evidence or history of bleeding diasthesis
- •Patients undergoing renal dialisis
- •History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
研究者
相似试验
招募中
2 期
Phase II study of sorafenib-regorafneib sequential therapy for the patients with advanced hepatocellular carcinoma previously treated with lenvatinibHepatocellular carcinomaJPRN-jRCT1041190082Yamashita Tatsuya33
进行中（未招募）
不适用
Sorafenib in the first line treatment of advanced hepatocellular carcinoma with ChildPugh liver function class B. Multicentre phase 3 randomized trial - BOOSTadvanced hepatocellular carcinoma with ChildPugh liver function class BMedDRA version: 9.1Level: LLTClassification code 10024720EUCTR2009-013870-42-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
招募中
不适用
The efficacy of sorafenib administration prior to TACE against the patients with intermediate HCC refractory to TACEHCCJPRN-UMIN000012636Keio University, School of Medicine10
已完成
2 期
Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.Hepatocellular carcinomaJPRN-UMIN000007199Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University25
尚未招募
不适用
Efficacy and Safety of Sorafenib in Previously treated Advanced Hepatocellular Carcinoma: SOPT studyNeoplasmsKCT0006739ational Cancer Center50