EUCTR2010-022620-77-GR进行中（未招募）1 期
A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with etoposide, or masitinib in combination with irinotecan in patients with advanced hepatocellular carcinoma and who relapsed after a first line therapy with sorafenib.
AB Science0 个研究点目标入组 34 人开始时间: 2015年8月6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
- 34
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
入选标准
- •1. ?istologically or cytologically confirmed advanced-stage hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) or responding to the Barcelona diagnostic criteria
- •2. Patient who has received sorafenib single agent as 1st line treatment and had discontinued from this treatment for any reason (ie, tumor disease progression, intolerance) at least 14 days prior to baseline (A line of treatment is defined as at least 1 prior therapeutic regimen consisting of chemotherapy or biologic agent). Requirement for sorafenib treatment is not applicable to patients who have not been previously treated with sorafenib for any reason (e.g., contra-indication to sorafenib, patient refusal to sorafenib treatment due to expected toxicity, etc.)
- •3. Patient who has recovered from any significant sorafenib-related treatment toxicities prior to baseline (=Grade 2)
- •4. Patient with at least 1 untreated target lesion that could be measured in 1 dimension:
- •according to the RECIST 1.1
- •and according to Modified RECIST assessment for hepatocellular carcinoma
- •5. Patient who has received local therapy prior to sorafenib administration (surgery, hepatic arterial embolization, chemoembolization, radioembolisation, radiofrequency ablation, percutaneous ethanol injection or cryoablation) are eligible. Local therapy must be completed at least 4 weeks prior to the baseline scan
- •6. Adequate antiviral systemic therapy in symptomatic and asymptomatic HBV Ag carriers
- •7. Patient eligible for receiving etoposide and irinotecan (either as a 2nd line treatment after sorafenib or 1st line for patient not previously treated with sorafenib)
- •8. Child-Pugh liver function class A
- •9. Barcelona Clinic Liver Cancer classification: class C
- •10. ECOG Performance Status = 2
- •11. Patient with adequate organ function:
- •ANC = 1.5 x 109/L
- •Hb = 10 g/dL
- •Platelets = 75 x 109/L
- •AST/ALT = 5 x ULN
- •?GT = 5 x ULN
- •Total bilirubin = 3 x ULN
- •Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •Albumin = 0.75 x LLN
- •Urea < 2 x ULN
- •Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hour
- •12. Patient with life expectancy > 3 months
- •13. = 18 years
- •14. weight > 40 kg and BMI > 18 kg/m²
- •15. Female patient of childbearing potential, who agrees to use 2 highly effective methods (1 for the patient and 1 for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Acceptable forms of contraception include:
- •A documented placement of an IUD or IUS and the use of a barrier method used with spermicidal
- •foam/gel/film/cream/suppository)
- •Documented tubal ligation (female sterilization). In addition, a barrier method should also be used
- •Double barrier method: Condom and occlusive cap with spermicidal foam/gel/film/cream/suppository
- •Any other con
排除标准
- •1. Patient intolerant to etoposide or irinotecan
- •2. Patient who has received a liver transplant
- •3. Patient with clinically significant symptoms of hepatic encephalopathy
- •4. Patient who has previously received more than two line of systemic therapy. One previous therapy must at least be with sorafenib monotherapy unless the patient has not been treated with sorafenib for any reason (e.g. contra-indication to sorafenib, patient refusal to sorafenib due to expected toxicity, etc.) (See Inclusion Criterion 2). Patients participating in surveys or observational studies are eligible to participate in this study.
- •5. Patient with previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 5 years prior to entry is permitted
- •6. Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
- •7. Pregnant or nursing female patient
- •8. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- •9. Patient with history of poor compliance, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
- •10. Patient treated with any investigational agent within 4 weeks prior baseline
- •11. Patient who has had treatment with any of the following within the specified timeframe prior to baseline:
- •Any sorafenib within the 14 days prior to baseline
- •Major surgery within the 4 weeks prior to baseline
- •Any transfusion, treatment with blood component preparation, received erythropoietin, albumin preparation, and granulocyte colony-stimulating factor (G CSF) within the 2 weeks prior to baseline
研究者
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