EUCTR2008-000973-40-HU进行中（未招募）不适用
A prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment
AB SCIENCE0 个研究点目标入组 222 人开始时间: 2009年10月8日最近更新:
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
- 222
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.Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
- •2.Patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
- •3.Measurable tumour lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according RECIST criteria
- •4.C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
- •5.ECOG < 1
- •6.Patient with adequate organ function:
- •absolute neutrophil count (ANC) = 1.5 x 109/L
- •Haemoglobin = 10 g/dL
- •platelets (PTL) = 100 x 109/L
- •AST/ALT = 2.5x ULN (= 5 x ULN in case of liver metastases)
- •bilirubin = 1.5x ULN
- •creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •albumin > 0.75 x LLN
- •urea = 1.5 x ULN
- •proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
- •7.Patient with life expectancy > 6 months
- •8.Men or women, age >18 years
- •9.Men and women of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
- •10.Patient should be able and willing to comply with study procedures as per protocol.
- •11.Patient should be able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
- •2.Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
- •3.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- •4.Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
- •5.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •6.Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
- •?Previous treatment
- •7.Treatment with any investigational agent within 4 weeks prior baseline
- •8.Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
研究者
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